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Hershel Jick - One of the best experts on this subject based on the ideXlab platform.
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the risk of unintended pregnancies in users of the Contraceptive Patch compared to users of oral Contraceptives in the uk general practice research database
Contraception, 2009Co-Authors: Susan S Jick, James A Kaye, Katrina Wilcox Hagberg, Hershel JickAbstract:Abstract Background The transdermal Contraceptive Patch EVRA has been marketed since 2002 as an alternative to oral Contraceptives (OCs), but large follow-up studies of effectiveness are lacking. Study Design We used a cohort plus a nested case-control study to estimate rates and hazard ratios of unintended pregnancy among users of different hormonal Contraceptives (HC) and to evaluate the effects of various potential predictors on unintended pregnancy. Results Rates of unintended pregnancy were all low (overall rate 0.17 per 100 women-years), though they were slightly higher in users of progestogen-only OCs and EVRA compared to users of second-generation OCs. The hazard ratios for unintended pregnancy were also higher for users of progestogen-only OCs and the Patch compared to users of second-generation OCs, although these estimates may be confounded by compliance. Rates of unintended pregnancy were inversely associated with age and duration of HC use as well as with other predictors of pregnancy but not body mass index or use of antibiotics. Conclusion The rates of unintended pregnancy were low for all study HCs, and while the data on unintended pregnancy in EVRA users compared to OC users are sufficient to rule out major differences in the rate of unintended pregnancy, they are not sufficient to rule out modest ones.
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further results on the risk of nonfatal venous thromboembolism in users of the Contraceptive transdermal Patch compared to users of oral Contraceptives containing norgestimate and 35 μg of ethinyl estradiol
Contraception, 2007Co-Authors: Susan S Jick, James A Kaye, Hershel JickAbstract:Abstract Context In 2006, we published a study that indicated that the new transdermal Contraceptive Patch containing ethinyl estradiol (EE) and the progestin norelgestromin did not increase the risk for venous thromboembolism (VTE) compared to oral Contraceptive containing norgestimate and 35 μg of EE. Objective This report updates information on the risk of nonfatal VTE in women using the Contraceptive Patch in comparison to women using oral Contraceptives containing norgestimate (either monophasic or triphasic) and 35 μg of EE (norgestimate-35) using an additional 17months of data. Design, Setting and Participants Nested case-control design based on information from PharMetrics, a US-based company that collects and organizes information on claims paid by managed care plans. The study was nested among all women, aged 15 to 44 years, who started either the Contraceptive Patch or norgestimate-35 after April 1, 2002. Cases were women with current use of one of these two study drugs and a documented diagnosis of VTE in the absence of identifiable clinical risk factors (idiopathic VTE) who were not in the earlier study. Up to four controls were matched to each case by age and calendar time. Main Outcome Measures Odds ratios (ORs) comparing the risk of nonfatal VTE in new users of the two Contraceptives. Results We identified 56 new cases of newly diagnosed, idiopathic VTE in the updated study population. The OR comparing the Contraceptive Patch to norgestimate-35 was 1.1 (95% CI 0.6–2.1). Conclusions After evaluating an additional 17 months of data, the results indicate that the risk of nonfatal VTE for the Contraceptive Patch is closely similar to the risk for oral Contraceptives containing 35 μg of EE and norgestimate.
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Original research article Further results on the risk of nonfatal venous thromboembolism in users of the Contraceptive transdermal Patch compared to users of oral Contraceptives containing norgestimate and 35 μg of ethinyl estradiol
2007Co-Authors: Susan S Jick, James A Kaye, Hershel JickAbstract:Context: In 2006, we published a study that indicated that the new transdermal Contraceptive Patch containing ethinyl estradiol (EE) and the progestin norelgestromin did not increase the risk for venous thromboembolism (VTE) compared to oral Contraceptive containing norgestimate and 35 μg of EE. Objective: This report updates information on the risk of nonfatal VTE in women using the Contraceptive Patch in comparison to women using oral Contraceptives containing norgestimate (either monophasic or triphasic) and 35 μg of EE (norgestimate-35) using an additional 17 months of data. Design, Setting and Participants: Nested case-control design based on information from PharMetrics, a US-based company that collects and organizes information on claims paid by managed care plans. The study was nested among all women, aged 15 to 44 years, who started either the Contraceptive Patch or norgestimate-35 after April 1, 2002. Cases were women with current use of one of these two study drugs and a documented diagnosis of VTE in the absence of identifiable clinical risk factors (idiopathic VTE) who were not in the earlier study. Up to four controls were matched to each case by age and calendar time. Main Outcome Measures: Odds ratios (ORs) comparing the risk of nonfatal VTE in new users of the two Contraceptives. Results: We identified 56 new cases of newly diagnosed, idiopathic VTE in the updated study population. The OR comparing the Contraceptive Patch to norgestimate-35 was 1.1 (95% CI 0.6–2.1). Conclusions: After evaluating an additional 17 months of data, the results indicate that the risk of nonfatal VTE for the Contraceptive Patch is closely similar to the risk for oral Contraceptives containing 35 μg of EE and norgestimate.
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Cerebral venous sinus thrombosis in users of four hormonal Contraceptives: levonorgestrel-containing oral Contraceptives, norgestimate-containing oral Contraceptives, desogestrel-containing oral Contraceptives and the Contraceptive Patch.
Contraception, 2006Co-Authors: Susan S Jick, Hershel JickAbstract:Abstract Background It has been suggested that the risk for cerebral venous sinus thrombosis (CVST) may be greater among users of the Contraceptive Patch than among users of oral Contraceptives (OCs). Methods From the PharMetrics database, we identified women aged 15–44 years who filled at least one prescription for either the Contraceptive Patch or desogestrel-containing, norgestimate-containing or levonorgestrel-containing OCs to assess the risk of CVST. The person-time of current exposure to each study drug, as well as the incidence rates (IRs) and incidence rate ratios (IRRs) of CVST, was calculated. Results We identified over 1 million users of the four study drugs. There were five cases of CVST among current users of desogestrel, seven cases among current users of norgestimate, two cases among current users of levonorgestrel and none among current users of the Contraceptive Patch. The IRs per 100,000 woman-years were 2.7 [95% confidence interval (95% CI)=0.9–6.3], 1.6 (95% CI=0.7–3.3), 0.7 (95% CI=0.1–2.4) and 0.0 (95% CI=0.0–4.8), respectively, in users of desogestrel, norgestimate, levonorgestrel and the Contraceptive Patch. There were two women who had CVST while not currently taking a hormonal Contraceptive (IR=0.4 per 100,000 woman-years; 95% CI=0.1–1.3). The IRRs were 4.0 (95% CI=0.7–42.4) for desogestrel-containing versus levonorgestrel-containing OCs, and 2.4 (95% CI=0.5–24.0) for norgestimate-containing versus levonorgestrel-containing OCs. The IRR for the Patch could not be calculated. Conclusions There is no evidence of an increased risk of CVST in users of the Contraceptive Patch compared to users of levonorgestrel-containing OCs.
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risk of nonfatal venous thromboembolism in women using a Contraceptive transdermal Patch and oral Contraceptives containing norgestimate and 35 μg of ethinyl estradiol
Contraception, 2006Co-Authors: Susan S Jick, James A Kaye, Stefan Russmann, Hershel JickAbstract:Abstract Context There is concern that a new transdermal Contraceptive Patch containing ethinyl estradiol (EE) and the progestin norelgestromin increases the risk for venous thromboembolism (VTE) compared to previously marketed oral Contraceptives (OCs). Objective Quantitative information was obtained on the risk of nonfatal VTE in women using the Contraceptive Patch in comparison to women using OCs, norgestimate (either monophasic or triphasic) and 35 μg EE (norgestimate-35), an OC that has been marketed for over a decade. Design, Setting and Participants Nested case-control design based on information from PharMetrics, a US-based company that collects and organizes information on claims paid by managed care plans. The study was nested among all women aged 15 to 44, who started either the Contraceptive Patch or norgestimate-35 after April 1, 2002. Cases were women with current use of one of these two study drugs and a documented diagnosis of VTE in the absence of identifiable clinical risk factors (idiopathic VTE). Up to four controls were matched to each case by age and calendar time. Main Outcome Measures Odds ratios (ORs) comparing the risk of nonfatal VTE in new users of the two Contraceptives and incidence rates of nonfatal VTE for new users of each of the study Contraceptives. Results We identified 68 newly diagnosed, idiopathic cases of VTE in the study population. In the case-control analysis, the OR comparing the Contraceptive Patch to norgestimate-35 was 0.9 (95% CI 0.5–1.6). The overall incidence rate for VTE was 52.8 per 100,000 women-years (95% CI 35.8–74.9) among users of the Contraceptive Patch and 41.8 per 100,000 women-years among users of norgestimate-35 (95% CI 29.4–57.6), and the age-adjusted VTE incidence rate ratio (IRR) for current use of the Contraceptive Patch vs. norgestimate-35 was 1.1 (95% CI 0.7–1.8). Conclusions The risk of nonfatal VTE for the Contraceptive Patch is similar to the risk for OCs containing 35 μg ethinylestradiol and norgestimate.
Alan C Fisher - One of the best experts on this subject based on the ideXlab platform.
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comparison of a transdermal Contraceptive Patch vs oral Contraceptives on hemostasis variables
Contraception, 2008Co-Authors: Cornelis Kluft, Katherine D. Laguardia, Piet Meijer, Alan C FisherAbstract:Purpose: The aim of this study was to compare effects of the transdermal Contraceptive Patch, a desogestrel/ethinyl estradiol (EE)-containing, monophasic combination oral Contraceptive (COC) and a levonorgestrel/EE-containing, triphasic COC on hemostasis variables. Study Design: This was a randomized, open-label study of 104 young women who received six cycles of treatment. Blood was collected at baseline and on treatment; changes by Day 20/Cycle 6 in baseline hemostasis markers [prothrombin fragment 1+2 (F 1+2), plasmin-plasmin inhibitor complex (PAP) and fibrin degradation products (d-dimer)] were assessed. Results: All Contraceptives induced similar increases in F 1+2 and d-dimer. Patch-induced PAP increases were less than with the monophasic and similar to the triphasic COC. Decreases in protein S and increases in sex hormone-binding globulin were greater with the Patch than with either COC. Patch-induced increases in activated protein C resistance were greater than with the triphasic and similar to the monophasic COC. Conclusion: These Contraceptives appeared to accelerate baseline procoagulation processes to a similar extent and to change coagulation potency variables differently. © 2008 Elsevier Inc. All rights reserved.
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original research article comparison of a transdermal Contraceptive Patch vs oral Contraceptives on hemostasis variables
2008Co-Authors: Cornelis Kluft, Katherine D. Laguardia, Piet Meijer, Alan C FisherAbstract:Purpose: The aim of this study was to compare effects of the transdermal Contraceptive Patch, a desogestrel/ethinyl estradiol (EE)containing, monophasic combination oral Contraceptive (COC) and a levonorgestrel/EE-containing, triphasic COC on hemostasis variables. Study Design: This was a randomized, open-label study of 104 young women who received six cycles of treatment. Blood was collected at baseline and on treatment; changes by Day 20/Cycle 6 in baseline hemostasis markers [prothrombin fragment 1+2 (F 1+2), plasmin–plasmin inhibitor complex (PAP) and fibrin degradation products (D-dimer)] were assessed. Results: All Contraceptives induced similar increases in F 1+2 and D-dimer. Patch-induced PAP increases were less than with the monophasic and similar to the triphasic COC. Decreases in protein S and increases in sex hormone-binding globulin were greater with the Patch than with either COC. Patch-induced increases in activated protein C resistance were greater than with the triphasic and similar to the monophasic COC. Conclusion: These Contraceptives appeared to accelerate baseline procoagulation processes to a similar extent and to change coagulation potency variables differently.
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Contraceptive efficacy compliance and beyond factors related to satisfaction with once weekly transdermal compared with oral contraception
European Journal of Obstetrics & Gynecology and Reproductive Biology, 2005Co-Authors: Wolfgang Urdl, Alan C Fisher, Dan Apter, Alan Alperstein, Peter Koll, Siegfried Schonian, Jacques Bringer, Michael PreikAbstract:Abstract Objective: To investigate Contraceptive efficacy, compliance and user's satisfaction with transdermal versus oral contraception (OC). Study design: Randomized, open-label, parallel-group trial conducted at 65 centers in Europe and South Africa. One thousand four hundred and eighty-nine women received a Contraceptive Patch ( n = 846) or an OC ( n = 643) for 6 or 13 cycles. Results: Overall/method-failure Pearl Indices were 0.88/0.66 with the Patch and 0.56/0.28 with the OC ( p = n.s.). Compliance was higher at all age groups with the Patch compared to the OC. Significantly more users were very satisfied with the Contraceptive Patch than with the OC. The percentage of Patch users being very satisfied increased with age whereas it did not in the OC group. Likewise, improvements of premenstrual symptoms as well as emotional and physical well-being increased with age in the Patch-group in contrast to the OC group. Ratings of satisfaction with the study medication correlated weakly with emotional ( r = 0.33) and physical well-being ( r = 0.39) as well as premenstrual symptoms ( r = 0.30; p Conclusion: Contraceptive efficacy of the Patch is comparable to OC, but compliance is consistently better at all age groups. Higher satisfaction with the Patch at increasing age may be attributed to improvements in emotional and physical well-being as well as reduction of premenstrual symptoms.
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extended use of transdermal norelgestromin ethinyl estradiol a randomized trial
Obstetrics & Gynecology, 2005Co-Authors: Felicia H Stewart, Katherine D. Laguardia, Andrew M Kaunitz, Debra L Karvois, Alan C Fisher, Andrew J FriedmanAbstract:OBJECTIVE:To compare bleeding profiles and satisfaction among women using a norelgestromin/ethinyl estradiol (E2) transdermal Contraceptive Patch in an extended regimen to those among women using a traditional 28-day Patch regimen.METHODS:Healthy, regularly menstruating women (N = 239) were randomly
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ortho evra evra versus oral Contraceptives follicular development and ovulation in normal cycles and after an intentional dosing error
Fertility and Sterility, 2003Co-Authors: R A Pierson, Alan C Fisher, David F Archer, Gary A Shangold, Michele Moreau, George W CreasyAbstract:Abstract Objective To compare the effects of the Contraceptive Patch to oral Contraceptives (OCs) on follicular size and incidence of ovulation in normal cycles and after dosing errors. Design Randomized, open-label. Setting Twelve centers. Patient(s) One hundred twenty-four ovulatory women. Intervention(s) Subjects received either the Patch (groups 1 and 2) or one of three OCs. Correct dosing occurred in cycles 1, 2, 3, and 5. The following dosing errors were planned during cycle 4, a shortened 10-day cycle: [1] Patch group 1 subjects wore one Patch for 10 consecutive days; [2] for Patch group 2 and OC subjects, 7 dosing days were followed by 3 drug-free days. Main outcome measure(s) Follicular size, as determined at each cycle by the maximum mean follicular diameter. Result(s) After a 3-day dosing error, follicular size was significantly smaller in the Patch group (mean, 7.0 mm) vs. each OC group (range of means, 11.8–17.1 mm). Similar results were seen after proper dosing. The incidence of ovulation was significantly lower for the Patch users than for women using OCs. Conclusion(s) Follicular size and incidence of ovulation were significantly reduced among Contraceptive Patch users compared with women using OCs in normal cycles and after planned dosing errors.
Kenneth F Schulz - One of the best experts on this subject based on the ideXlab platform.
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skin Patch and vaginal ring versus combined oral Contraceptives for contraception
Cochrane Database of Systematic Reviews, 2013Co-Authors: Laureen M. Lopez, Laurie L Stockton, Maria F Gallo, David A Grimes, Kenneth F SchulzAbstract:BACKGROUND: The delivery of combination Contraceptive steroids from a transdermal Contraceptive Patch or a Contraceptive vaginal ring offers potential advantages over the traditional oral route. The transdermal Patch and vaginal ring could require a lower dose due to increased bioavailability and improved user compliance. OBJECTIVES: To compare the Contraceptive effectiveness cycle control compliance (adherence) and safety of the Contraceptive Patch or the vaginal ring versus combination oral Contraceptives (COCs). SEARCH METHODS: Through February 2013 we searched MEDLINE POPLINE CENTRAL LILACS ClinicalTrials.gov and ICTRP for trials of the Contraceptive Patch or the vaginal ring. Earlier searches also included EMBASE. For the initial review we contacted known researchers and manufacturers to identify other trials. SELECTION CRITERIA: We considered randomized controlled trials comparing a transdermal Contraceptive Patch or a Contraceptive vaginal ring with a COC. DATA COLLECTION AND ANALYSIS: Data were abstracted by two authors and entered into RevMan. For dichotomous variables the Peto odds ratio (OR) with 95% confidence intervals (CI) was calculated. For continuous variables the mean difference was computed. We also assessed the quality of evidence for this review. MAIN RESULTS: We found 18 trials that met our inclusion criteria. Of six Patch studies five examined the marketed Patch containing norelgestromin plus ethinyl estradiol (EE); one studied a Patch in development that contains levonorgestrel (LNG) plus EE. Of 12 vaginal ring trials 11 examined the same marketing ring containing etonogestrel plus EE; one studied a ring being developed that contains nesterone plus EE.Contraceptive effectiveness was not significantly different for the Patch or ring versus the comparison COC. Compliance data were limited. Patch users showed better compliance than COC users in three trials. For the norelgestromin plus EE Patch ORs were 2.05 (95% CI 1.83 to 2.29) and 2.76 (95% CI 2.35 to 3.24). In the levonorgestrel plus EE Patch report Patch users were less likely to have missed days of therapy (OR 0.36; 95% CI 0.25 to 0.51). Of four vaginal ring trials one found ring users had more noncompliance (OR 3.99; 95% CI 1.87 to 8.52) while another showed more compliance with the regimen (OR 1.67; 95% CI 1.04 to 2.68).More Patch users discontinued early than COC users. ORs from two meta-analyses were 1.59 (95% CI 1.26 to 2.00) and 1.56 (95% CI 1.18 to 2.06) and another trial showed OR 2.57 (95% CI 0.99 to 6.64). Patch users also had more discontinuation due to adverse events than COC users. Users of the norelgestromin-containing Patch reported more breast discomfort dysmenorrhea nausea and vomiting. In the levonorgestrel-containing Patch trial Patch users reported less vomiting headaches and fatigue.Of 11 ring trials with discontinuation data two showed the ring group discontinued less than the COC group: OR 0.32 (95% CI 0.16 to 0.66) and OR 0.52 (95% CI 0.31 to 0.88). Ring users were less likely to discontinue due to adverse events in one study (OR 0.32; 95% CI 0.15 to 0.70). Compared to the COC users ring users had more vaginitis and leukorrhea but less vaginal dryness. Ring users also reported less nausea acne irritability depression and emotional lability than COC users.For cycle control only one trial study showed a significant difference. Women in the Patch group were less likely to have breakthrough bleeding and spotting. Seven ring studies had bleeding data; four trials showed the ring group generally had better cycle control than the COC group. AUTHORS CONCLUSIONS: Effectiveness was not significantly different for the methods compared. Pregnancy data were available from half of the Patch trials but two-thirds of ring trials. The Patch could lead to more discontinuation than the COC. The Patch group had better compliance than the COC group. Compliance data came from half of the Patch studies and one-third of the ring trials. Patch users had more side effects than the COC group. Ring users generally had fewer adverse events than COC users but more vaginal irritation and discharge.The quality of the evidence for this review was considered low for the Patch and moderate for the ring. The main reasons for downgrading were lack of information on the randomization sequence generation or allocation concealment the outcome assessment methods high losses to follow up and exclusions after randomization.
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skin Patch and vaginal ring versus combined oral Contraceptives for contraception
Cochrane Database of Systematic Reviews, 2013Co-Authors: Laureen M. Lopez, Laurie L Stockton, Maria F Gallo, David A Grimes, Kenneth F SchulzAbstract:BACKGROUND: The delivery of combination Contraceptive steroids from a transdermal Contraceptive Patch or a Contraceptive vaginal ring offers potential advantages over the traditional oral route. The transdermal Patch and vaginal ring could require a lower dose due to increased bioavailability and improved user compliance. OBJECTIVES: To compare the Contraceptive effectiveness cycle control compliance (adherence) and safety of the Contraceptive Patch or the vaginal ring versus combination oral Contraceptives (COCs). SEARCH METHODS: Through February 2013 we searched MEDLINE POPLINE CENTRAL LILACS ClinicalTrials.gov and ICTRP for trials of the Contraceptive Patch or the vaginal ring. Earlier searches also included EMBASE. For the initial review we contacted known researchers and manufacturers to identify other trials. SELECTION CRITERIA: We considered randomized controlled trials comparing a transdermal Contraceptive Patch or a Contraceptive vaginal ring with a COC. DATA COLLECTION AND ANALYSIS: Data were abstracted by two authors and entered into RevMan. For dichotomous variables the Peto odds ratio (OR) with 95% confidence intervals (CI) was calculated. For continuous variables the mean difference was computed. We also assessed the quality of evidence for this review. MAIN RESULTS: We found 18 trials that met our inclusion criteria. Of six Patch studies five examined the marketed Patch containing norelgestromin plus ethinyl estradiol (EE); one studied a Patch in development that contains levonorgestrel (LNG) plus EE. Of 12 vaginal ring trials 11 examined the same marketing ring containing etonogestrel plus EE; one studied a ring being developed that contains nesterone plus EE.Contraceptive effectiveness was not significantly different for the Patch or ring versus the comparison COC. Compliance data were limited. Patch users showed better compliance than COC users in three trials. For the norelgestromin plus EE Patch ORs were 2.05 (95% CI 1.83 to 2.29) and 2.76 (95% CI 2.35 to 3.24). In the levonorgestrel plus EE Patch report Patch users were less likely to have missed days of therapy (OR 0.36; 95% CI 0.25 to 0.51). Of four vaginal ring trials one found ring users had more noncompliance (OR 3.99; 95% CI 1.87 to 8.52) while another showed more compliance with the regimen (OR 1.67; 95% CI 1.04 to 2.68).More Patch users discontinued early than COC users. ORs from two meta-analyses were 1.59 (95% CI 1.26 to 2.00) and 1.56 (95% CI 1.18 to 2.06) and another trial showed OR 2.57 (95% CI 0.99 to 6.64). Patch users also had more discontinuation due to adverse events than COC users. Users of the norelgestromin-containing Patch reported more breast discomfort dysmenorrhea nausea and vomiting. In the levonorgestrel-containing Patch trial Patch users reported less vomiting headaches and fatigue.Of 11 ring trials with discontinuation data two showed the ring group discontinued less than the COC group: OR 0.32 (95% CI 0.16 to 0.66) and OR 0.52 (95% CI 0.31 to 0.88). Ring users were less likely to discontinue due to adverse events in one study (OR 0.32; 95% CI 0.15 to 0.70). Compared to the COC users ring users had more vaginitis and leukorrhea but less vaginal dryness. Ring users also reported less nausea acne irritability depression and emotional lability than COC users.For cycle control only one trial study showed a significant difference. Women in the Patch group were less likely to have breakthrough bleeding and spotting. Seven ring studies had bleeding data; four trials showed the ring group generally had better cycle control than the COC group. AUTHORS CONCLUSIONS: Effectiveness was not significantly different for the methods compared. Pregnancy data were available from half of the Patch trials but two-thirds of ring trials. The Patch could lead to more discontinuation than the COC. The Patch group had better compliance than the COC group. Compliance data came from half of the Patch studies and one-third of the ring trials. Patch users had more side effects than the COC group. Ring users generally had fewer adverse events than COC users but more vaginal irritation and discharge.The quality of the evidence for this review was considered low for the Patch and moderate for the ring. The main reasons for downgrading were lack of information on the randomization sequence generation or allocation concealment the outcome assessment methods high losses to follow up and exclusions after randomization.
Susan S Jick - One of the best experts on this subject based on the ideXlab platform.
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the risk of unintended pregnancies in users of the Contraceptive Patch compared to users of oral Contraceptives in the uk general practice research database
Contraception, 2009Co-Authors: Susan S Jick, James A Kaye, Katrina Wilcox Hagberg, Hershel JickAbstract:Abstract Background The transdermal Contraceptive Patch EVRA has been marketed since 2002 as an alternative to oral Contraceptives (OCs), but large follow-up studies of effectiveness are lacking. Study Design We used a cohort plus a nested case-control study to estimate rates and hazard ratios of unintended pregnancy among users of different hormonal Contraceptives (HC) and to evaluate the effects of various potential predictors on unintended pregnancy. Results Rates of unintended pregnancy were all low (overall rate 0.17 per 100 women-years), though they were slightly higher in users of progestogen-only OCs and EVRA compared to users of second-generation OCs. The hazard ratios for unintended pregnancy were also higher for users of progestogen-only OCs and the Patch compared to users of second-generation OCs, although these estimates may be confounded by compliance. Rates of unintended pregnancy were inversely associated with age and duration of HC use as well as with other predictors of pregnancy but not body mass index or use of antibiotics. Conclusion The rates of unintended pregnancy were low for all study HCs, and while the data on unintended pregnancy in EVRA users compared to OC users are sufficient to rule out major differences in the rate of unintended pregnancy, they are not sufficient to rule out modest ones.
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further results on the risk of nonfatal venous thromboembolism in users of the Contraceptive transdermal Patch compared to users of oral Contraceptives containing norgestimate and 35 μg of ethinyl estradiol
Contraception, 2007Co-Authors: Susan S Jick, James A Kaye, Hershel JickAbstract:Abstract Context In 2006, we published a study that indicated that the new transdermal Contraceptive Patch containing ethinyl estradiol (EE) and the progestin norelgestromin did not increase the risk for venous thromboembolism (VTE) compared to oral Contraceptive containing norgestimate and 35 μg of EE. Objective This report updates information on the risk of nonfatal VTE in women using the Contraceptive Patch in comparison to women using oral Contraceptives containing norgestimate (either monophasic or triphasic) and 35 μg of EE (norgestimate-35) using an additional 17months of data. Design, Setting and Participants Nested case-control design based on information from PharMetrics, a US-based company that collects and organizes information on claims paid by managed care plans. The study was nested among all women, aged 15 to 44 years, who started either the Contraceptive Patch or norgestimate-35 after April 1, 2002. Cases were women with current use of one of these two study drugs and a documented diagnosis of VTE in the absence of identifiable clinical risk factors (idiopathic VTE) who were not in the earlier study. Up to four controls were matched to each case by age and calendar time. Main Outcome Measures Odds ratios (ORs) comparing the risk of nonfatal VTE in new users of the two Contraceptives. Results We identified 56 new cases of newly diagnosed, idiopathic VTE in the updated study population. The OR comparing the Contraceptive Patch to norgestimate-35 was 1.1 (95% CI 0.6–2.1). Conclusions After evaluating an additional 17 months of data, the results indicate that the risk of nonfatal VTE for the Contraceptive Patch is closely similar to the risk for oral Contraceptives containing 35 μg of EE and norgestimate.
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the Contraceptive Patch in relation to ischemic stroke and acute myocardial infarction
Pharmacotherapy, 2007Co-Authors: Susan S Jick, M Hershel D JickAbstract:Study Objective. To compare rates of stroke and acute myocardial infarction in users of the Ortho EVRA Contraceptive Patch with these rates in users of norgestimate-containing oral Contraceptives (OCs) with 35 μg of ethinyl estradiol. Design. Retrospective, population-based, epidemiologic study. Data Source. PharMetrics database. Subjects. Females aged 15–45 years in the PharMetrics database who had filled at least one prescription for the Ortho EVRA Contraceptive Patch or a norgestimate OC between April 1, 2002, and March 31, 2005. Measurements and Main Results. Incidence rates and 95% confidence intervals (CI) were estimated for the outcomes of ischemic stroke and acute myocardial infarction by exposure. Crude incidence rates of ischemic stroke among users of the Patch and users of norgestimate OCs were 13.6/100,000 woman-years (95% CI 5.9–26.8) and 11.3/100,000 woman-years (95% CI 5.4–20.8), respectively. The crude incidence rate of acute myocardial infarction was 1.7/100,000 woman-years (95% CI 0.04–9.5) in current Patch users and 7.9/100,000 woman-years (95% CI 3.2–16.3) in current users of norgestimate OCs. Incidence rate ratios (IRRs) were estimated for the outcomes by comparing data for users of the Patch and users of a norgestimate OC. The IRR for stroke was 1.2 (95% CI 0.41–3.4) and for acute myocardial infarction was 0.2 (95% CI 0.004–1.7). Conclusion. Ischemic stroke and acute myocardial infarction are rare among young women who use hormonal Contraceptives, and the current data provide no suggestion of an increased risk of either ischemic stroke or acute myocardial infarction in users of the Ortho EVRA Contraceptive Patch compared with users of norgestimate OCs.
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Original research article Further results on the risk of nonfatal venous thromboembolism in users of the Contraceptive transdermal Patch compared to users of oral Contraceptives containing norgestimate and 35 μg of ethinyl estradiol
2007Co-Authors: Susan S Jick, James A Kaye, Hershel JickAbstract:Context: In 2006, we published a study that indicated that the new transdermal Contraceptive Patch containing ethinyl estradiol (EE) and the progestin norelgestromin did not increase the risk for venous thromboembolism (VTE) compared to oral Contraceptive containing norgestimate and 35 μg of EE. Objective: This report updates information on the risk of nonfatal VTE in women using the Contraceptive Patch in comparison to women using oral Contraceptives containing norgestimate (either monophasic or triphasic) and 35 μg of EE (norgestimate-35) using an additional 17 months of data. Design, Setting and Participants: Nested case-control design based on information from PharMetrics, a US-based company that collects and organizes information on claims paid by managed care plans. The study was nested among all women, aged 15 to 44 years, who started either the Contraceptive Patch or norgestimate-35 after April 1, 2002. Cases were women with current use of one of these two study drugs and a documented diagnosis of VTE in the absence of identifiable clinical risk factors (idiopathic VTE) who were not in the earlier study. Up to four controls were matched to each case by age and calendar time. Main Outcome Measures: Odds ratios (ORs) comparing the risk of nonfatal VTE in new users of the two Contraceptives. Results: We identified 56 new cases of newly diagnosed, idiopathic VTE in the updated study population. The OR comparing the Contraceptive Patch to norgestimate-35 was 1.1 (95% CI 0.6–2.1). Conclusions: After evaluating an additional 17 months of data, the results indicate that the risk of nonfatal VTE for the Contraceptive Patch is closely similar to the risk for oral Contraceptives containing 35 μg of EE and norgestimate.
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Cerebral venous sinus thrombosis in users of four hormonal Contraceptives: levonorgestrel-containing oral Contraceptives, norgestimate-containing oral Contraceptives, desogestrel-containing oral Contraceptives and the Contraceptive Patch.
Contraception, 2006Co-Authors: Susan S Jick, Hershel JickAbstract:Abstract Background It has been suggested that the risk for cerebral venous sinus thrombosis (CVST) may be greater among users of the Contraceptive Patch than among users of oral Contraceptives (OCs). Methods From the PharMetrics database, we identified women aged 15–44 years who filled at least one prescription for either the Contraceptive Patch or desogestrel-containing, norgestimate-containing or levonorgestrel-containing OCs to assess the risk of CVST. The person-time of current exposure to each study drug, as well as the incidence rates (IRs) and incidence rate ratios (IRRs) of CVST, was calculated. Results We identified over 1 million users of the four study drugs. There were five cases of CVST among current users of desogestrel, seven cases among current users of norgestimate, two cases among current users of levonorgestrel and none among current users of the Contraceptive Patch. The IRs per 100,000 woman-years were 2.7 [95% confidence interval (95% CI)=0.9–6.3], 1.6 (95% CI=0.7–3.3), 0.7 (95% CI=0.1–2.4) and 0.0 (95% CI=0.0–4.8), respectively, in users of desogestrel, norgestimate, levonorgestrel and the Contraceptive Patch. There were two women who had CVST while not currently taking a hormonal Contraceptive (IR=0.4 per 100,000 woman-years; 95% CI=0.1–1.3). The IRRs were 4.0 (95% CI=0.7–42.4) for desogestrel-containing versus levonorgestrel-containing OCs, and 2.4 (95% CI=0.5–24.0) for norgestimate-containing versus levonorgestrel-containing OCs. The IRR for the Patch could not be calculated. Conclusions There is no evidence of an increased risk of CVST in users of the Contraceptive Patch compared to users of levonorgestrel-containing OCs.
Laureen M. Lopez - One of the best experts on this subject based on the ideXlab platform.
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skin Patch and vaginal ring versus combined oral Contraceptives for contraception
Cochrane Database of Systematic Reviews, 2013Co-Authors: Laureen M. Lopez, Laurie L Stockton, Maria F Gallo, David A Grimes, Kenneth F SchulzAbstract:BACKGROUND: The delivery of combination Contraceptive steroids from a transdermal Contraceptive Patch or a Contraceptive vaginal ring offers potential advantages over the traditional oral route. The transdermal Patch and vaginal ring could require a lower dose due to increased bioavailability and improved user compliance. OBJECTIVES: To compare the Contraceptive effectiveness cycle control compliance (adherence) and safety of the Contraceptive Patch or the vaginal ring versus combination oral Contraceptives (COCs). SEARCH METHODS: Through February 2013 we searched MEDLINE POPLINE CENTRAL LILACS ClinicalTrials.gov and ICTRP for trials of the Contraceptive Patch or the vaginal ring. Earlier searches also included EMBASE. For the initial review we contacted known researchers and manufacturers to identify other trials. SELECTION CRITERIA: We considered randomized controlled trials comparing a transdermal Contraceptive Patch or a Contraceptive vaginal ring with a COC. DATA COLLECTION AND ANALYSIS: Data were abstracted by two authors and entered into RevMan. For dichotomous variables the Peto odds ratio (OR) with 95% confidence intervals (CI) was calculated. For continuous variables the mean difference was computed. We also assessed the quality of evidence for this review. MAIN RESULTS: We found 18 trials that met our inclusion criteria. Of six Patch studies five examined the marketed Patch containing norelgestromin plus ethinyl estradiol (EE); one studied a Patch in development that contains levonorgestrel (LNG) plus EE. Of 12 vaginal ring trials 11 examined the same marketing ring containing etonogestrel plus EE; one studied a ring being developed that contains nesterone plus EE.Contraceptive effectiveness was not significantly different for the Patch or ring versus the comparison COC. Compliance data were limited. Patch users showed better compliance than COC users in three trials. For the norelgestromin plus EE Patch ORs were 2.05 (95% CI 1.83 to 2.29) and 2.76 (95% CI 2.35 to 3.24). In the levonorgestrel plus EE Patch report Patch users were less likely to have missed days of therapy (OR 0.36; 95% CI 0.25 to 0.51). Of four vaginal ring trials one found ring users had more noncompliance (OR 3.99; 95% CI 1.87 to 8.52) while another showed more compliance with the regimen (OR 1.67; 95% CI 1.04 to 2.68).More Patch users discontinued early than COC users. ORs from two meta-analyses were 1.59 (95% CI 1.26 to 2.00) and 1.56 (95% CI 1.18 to 2.06) and another trial showed OR 2.57 (95% CI 0.99 to 6.64). Patch users also had more discontinuation due to adverse events than COC users. Users of the norelgestromin-containing Patch reported more breast discomfort dysmenorrhea nausea and vomiting. In the levonorgestrel-containing Patch trial Patch users reported less vomiting headaches and fatigue.Of 11 ring trials with discontinuation data two showed the ring group discontinued less than the COC group: OR 0.32 (95% CI 0.16 to 0.66) and OR 0.52 (95% CI 0.31 to 0.88). Ring users were less likely to discontinue due to adverse events in one study (OR 0.32; 95% CI 0.15 to 0.70). Compared to the COC users ring users had more vaginitis and leukorrhea but less vaginal dryness. Ring users also reported less nausea acne irritability depression and emotional lability than COC users.For cycle control only one trial study showed a significant difference. Women in the Patch group were less likely to have breakthrough bleeding and spotting. Seven ring studies had bleeding data; four trials showed the ring group generally had better cycle control than the COC group. AUTHORS CONCLUSIONS: Effectiveness was not significantly different for the methods compared. Pregnancy data were available from half of the Patch trials but two-thirds of ring trials. The Patch could lead to more discontinuation than the COC. The Patch group had better compliance than the COC group. Compliance data came from half of the Patch studies and one-third of the ring trials. Patch users had more side effects than the COC group. Ring users generally had fewer adverse events than COC users but more vaginal irritation and discharge.The quality of the evidence for this review was considered low for the Patch and moderate for the ring. The main reasons for downgrading were lack of information on the randomization sequence generation or allocation concealment the outcome assessment methods high losses to follow up and exclusions after randomization.
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skin Patch and vaginal ring versus combined oral Contraceptives for contraception
Cochrane Database of Systematic Reviews, 2013Co-Authors: Laureen M. Lopez, Laurie L Stockton, Maria F Gallo, David A Grimes, Kenneth F SchulzAbstract:BACKGROUND: The delivery of combination Contraceptive steroids from a transdermal Contraceptive Patch or a Contraceptive vaginal ring offers potential advantages over the traditional oral route. The transdermal Patch and vaginal ring could require a lower dose due to increased bioavailability and improved user compliance. OBJECTIVES: To compare the Contraceptive effectiveness cycle control compliance (adherence) and safety of the Contraceptive Patch or the vaginal ring versus combination oral Contraceptives (COCs). SEARCH METHODS: Through February 2013 we searched MEDLINE POPLINE CENTRAL LILACS ClinicalTrials.gov and ICTRP for trials of the Contraceptive Patch or the vaginal ring. Earlier searches also included EMBASE. For the initial review we contacted known researchers and manufacturers to identify other trials. SELECTION CRITERIA: We considered randomized controlled trials comparing a transdermal Contraceptive Patch or a Contraceptive vaginal ring with a COC. DATA COLLECTION AND ANALYSIS: Data were abstracted by two authors and entered into RevMan. For dichotomous variables the Peto odds ratio (OR) with 95% confidence intervals (CI) was calculated. For continuous variables the mean difference was computed. We also assessed the quality of evidence for this review. MAIN RESULTS: We found 18 trials that met our inclusion criteria. Of six Patch studies five examined the marketed Patch containing norelgestromin plus ethinyl estradiol (EE); one studied a Patch in development that contains levonorgestrel (LNG) plus EE. Of 12 vaginal ring trials 11 examined the same marketing ring containing etonogestrel plus EE; one studied a ring being developed that contains nesterone plus EE.Contraceptive effectiveness was not significantly different for the Patch or ring versus the comparison COC. Compliance data were limited. Patch users showed better compliance than COC users in three trials. For the norelgestromin plus EE Patch ORs were 2.05 (95% CI 1.83 to 2.29) and 2.76 (95% CI 2.35 to 3.24). In the levonorgestrel plus EE Patch report Patch users were less likely to have missed days of therapy (OR 0.36; 95% CI 0.25 to 0.51). Of four vaginal ring trials one found ring users had more noncompliance (OR 3.99; 95% CI 1.87 to 8.52) while another showed more compliance with the regimen (OR 1.67; 95% CI 1.04 to 2.68).More Patch users discontinued early than COC users. ORs from two meta-analyses were 1.59 (95% CI 1.26 to 2.00) and 1.56 (95% CI 1.18 to 2.06) and another trial showed OR 2.57 (95% CI 0.99 to 6.64). Patch users also had more discontinuation due to adverse events than COC users. Users of the norelgestromin-containing Patch reported more breast discomfort dysmenorrhea nausea and vomiting. In the levonorgestrel-containing Patch trial Patch users reported less vomiting headaches and fatigue.Of 11 ring trials with discontinuation data two showed the ring group discontinued less than the COC group: OR 0.32 (95% CI 0.16 to 0.66) and OR 0.52 (95% CI 0.31 to 0.88). Ring users were less likely to discontinue due to adverse events in one study (OR 0.32; 95% CI 0.15 to 0.70). Compared to the COC users ring users had more vaginitis and leukorrhea but less vaginal dryness. Ring users also reported less nausea acne irritability depression and emotional lability than COC users.For cycle control only one trial study showed a significant difference. Women in the Patch group were less likely to have breakthrough bleeding and spotting. Seven ring studies had bleeding data; four trials showed the ring group generally had better cycle control than the COC group. AUTHORS CONCLUSIONS: Effectiveness was not significantly different for the methods compared. Pregnancy data were available from half of the Patch trials but two-thirds of ring trials. The Patch could lead to more discontinuation than the COC. The Patch group had better compliance than the COC group. Compliance data came from half of the Patch studies and one-third of the ring trials. Patch users had more side effects than the COC group. Ring users generally had fewer adverse events than COC users but more vaginal irritation and discharge.The quality of the evidence for this review was considered low for the Patch and moderate for the ring. The main reasons for downgrading were lack of information on the randomization sequence generation or allocation concealment the outcome assessment methods high losses to follow up and exclusions after randomization.