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Mitchell D Creinin - One of the best experts on this subject based on the ideXlab platform.
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six year contraceptive efficacy and continued safety of a Levonorgestrel 52 mg intrauterine system
Contraception, 2020Co-Authors: Carolyn Westhoff, Lisa M Keder, A Gangestad, Stephanie B Teal, Andrea I Olariu, Mitchell D CreininAbstract:Abstract Objective To assess 6-year contraceptive efficacy and safety of a Levonorgestrel 52 mg intrauterine system (IUS). Study Design We assessed pregnancy rates through 72 months in women aged 16–35 years at enrollment and safety in all participants (aged 16–45 years, n = 1751) in an ongoing 10-year phase-3 trial. Results Over six years, nine pregnancies occurred (none in year 6) for a life-table pregnancy rate of 0.87 (95% CI 0.44–1.70). Adverse event rates remain low through 6 or more years of use. Two expulsions occurred in year 6. Conclusion This Levonorgestrel 52 mg IUS is a highly effective and safe contraceptive over 6 years of use. Implications The Levonorgestrel 52 mg IUS shows high 6-year contraceptive efficacy and a low rate of adverse events through 6 or more years of use.
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comparing bleeding patterns for the Levonorgestrel 52 mg 19 5 mg and 13 5 mg intrauterine systems
Contraception, 2019Co-Authors: Lisa M Goldthwaite, Mitchell D CreininAbstract:Abstract Objective Compare bleeding patterns for Levonorgestrel 52 mg, 19.5 mg, and 13.5 mg intrauterine system (IUS) products using the World Health Organization Belsey definitions. Study design We extracted available data on bleeding patterns from published sources. Lower dose products had published data at 1 and 3 years; the 52 mg IUS had available data for 1, 2 and 3 years for amenorrhea and 1 and 2 years for other bleeding patterns. We interpolated 2-year data for the lower dose products based on 1- and 3-year data and compared bleeding pattern rates using Fisher exact testing. Results The studies evaluated bleeding patterns in 1700, 1566 and 1531 women using Levonorgestrel 52 mg, 19.5 mg and 13.5 mg products, respectively. Amenorrhea rates were greater by 180 days after insertion for 52 mg IUS users (11%) as compared to 19.5 mg (5%, p Conclusions Levonorgestrel 52 mg IUS users have more amenorrhea and infrequent bleeding and less irregular bleeding compared to women using lower dose Levonorgestrel IUS products. Implications Statement All women considering Levonorgestrel IUS placement should receive counseling on the differences in bleeding patterns related to the various available doses. Women who are interested in maximizing the likelihood of favorable bleeding should consider a Levonorgestrel 52 mg IUS over the lower dose alternatives.
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progesterone receptor modulator for emergency contraception a randomized controlled trial
Obstetrics & Gynecology, 2006Co-Authors: Mitchell D Creinin, William D Schlaff, David F Archer, Ron G Frezieres, Michael A Thomas, Michael J Rosenberg, Jim HigginsAbstract:OBJECTIVE: Compare the efficacy and adverse effects of CDB-2914, a new progesterone receptor modulator, to Levonorgestrel for emergency contraception. METHODS: We performed a randomized, doubleblinded noninferiority trial, enrolling healthy women seeking emergency contraception within 72 hours of unprotected intercourse. Participants were randomly assigned to receive a single dose of 50 mg of CDB-2914, plus a placebo 12 hours later or two doses of 0.75 mg of Levonorgestrel taken 12 hours apart. Follow-up was scheduled 5 to 7 days after the expected onset of the next menstrual period. Posttreatment pregnancy was established by a positive urine test at follow-up and confirmed by quantitative serum -hCG. Daily diaries were used from the time of emergency contraception use until next menses to record adverse effects and sexual activity. RESULTS: Product efficacy was evaluable in 775 of CDB2914 users and 774 of Levonorgestrel users. Pregnancies occurred in 7 (0.9%, 95% confidence interval 0.2–1.6%) and 13 (1.7%, 95% confidence interval 0.8–2.6%) women, respectively. Based on the estimated cycle day of unprotected intercourse, 85% and 69% of anticipated pregnancies, respectively, were averted. Nausea was reported by a somewhat greater percentage of CDB-2914 than Levonorgestrel users (29% compared with 24%, P.03), but the distribution of other adverse effects was similar in both groups. Women in both groups experienced considerable variation in menstrual cycle length as compared with their reported individual normal cycle lengths. CONCLUSION: CDB-2914 is at least as effective as Levonorgestrel in preventing pregnancies after unprotected intercourse and has a similar side effect profile. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www. clinicaltrials.gov, NCT00271583 (Obstet Gynecol 2006;108:1089–97) LEVEL OF EVIDENCE: I
Hershel Jick - One of the best experts on this subject based on the ideXlab platform.
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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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Original research article Cerebral venous sinus thrombosis in users of four hormonal contraceptives: Levonorgestrel-containing oral contraceptives, norgestimate-containing oral contraceptives, desogestrel-containing oral contraceptives and the contra
2006Co-Authors: Susan S. Jick, Hershel JickAbstract: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 CVSTamong 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 Levonorgestrelcontaining OCs.
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risk of venous thromboembolism with cyproterone or Levonorgestrel contraceptives
The Lancet, 2001Co-Authors: Catherine Vasilakisscaramozza, Hershel JickAbstract:Summary Results of studies have shown that there is an excess risk of venous thromboembolism in users of oral contraceptives containing cyproterone compared with those containing Levonorgestrel. We did a case-control study, in which we assessed the risk of idiopathic venous thromboembolism in women taking combined low-dose oestrogen oral contraceptives containing cyproterone (n=24 401) or Levonorgestrel (n=75 000). We compared the 26 women in this population who had idiopathic venous thromboembolism with 144 matched controls. 12 individuals and 30 controls were taking contraceptives that contained cyproterone. Our results suggest that risk of venous thromboembolism is increased four-fold in women taking contraceptives containing cyproterone by comparison with those exposed to Levonorgestrel.
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risk of idiopathic cardiovascular death and rionfatal venous thromboembolism in women using oral contraceptives with differing progestagen components
The Lancet, 1995Co-Authors: Hershel Jick, Marian Wald Myers, Catherine Vasilakis, Susan S. Jick, Victor GurewichAbstract:Abstract Summary Concern about the risks of cardiovascular illness in women using combined oral contraceptives (OC) containing the progestagens desogestrel and gestodene prompted two studies of data from the UK General Practice Research Database. We compared the risks of certain cardiovascular illnesses in otherwise healthy women exposed to one of three OCs containing In the first study, based on some 470 general practices, there were 15 cases of unexpected idiopathic cardiovascular death among 303 470 women who were current users of one of the study OCs. The estimated incidence rates were 8/184 536 (4·3 per 100 000) woman-years at risk for users of combined OCs containing Levonorgestrel, 2/135567 (1·5 per 100 000) for desogestrel users, and 5/105 201 (4·8 per 100 000) for gestodene users. The relative risk (RR) estimates were 0·4 (95% Cl 0·1-2·1) and 1·4 (Cl 0·5-4·5) for desogestrel and gestodene, respectively, compared with Levonorgestrel. In the second study, derived from some 370 general practices, there were 80 cases of nonfatal venous thromboembolism (VTE) in a cohort of 238 130 otherwise healthy women. The incidence rates of VTE per 100 000 woman-years at risk were 16·1 for Levonorgestrel users, 29·3 for desogestrel, and 28·1 for gestodene. The adjusted RR estimates from the cohort analysis were 1·9 (1·1-3·2) and 1·8 (1·0-3·2) for desogestrel and gestodene users, respectively, compared with users of Levonorgestrel. In a nested case-control analysis the adjusted matched RR estimates were 2·2 (1·1-4·4) and 2·1 (1·0-4·4) for desogestrel and gestodene users, respectively, compared with users of Levonorgestrel. The excess risk for nonfatal VTE associated with the new generation of combined OCs containing low-dose oestrogen and the progestagens desogestrel or gestodene compared with Levonorgestrel is estimated to be 16 per 100 000 woman-years.
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risk of idiopathic cardiovascular death and rionfatal venous thromboembolism in women using oral contraceptives with differing progestagen components
The Lancet, 1995Co-Authors: Hershel Jick, Marian Wald Myers, Catherine Vasilakis, Susan S. Jick, Victor GurewichAbstract:Concern about the risks of cardiovascular illness in women using combined oral contraceptives (OC) containing the progestagens desogestrel and gestodene prompted two studies of data from the UK General Practice Research Database. We compared the risks of certain cardiovascular illnesses in otherwise healthy women exposed to one of three OCs containing < 35 micrograms oestrogen plus Levonorgestrel, desogestrel, or gestodene. In the first study, based on some 470 general practices, there were 15 cases of unexpected idiopathic cardiovascular death among 303,470 women who were current users of one of the study OCs. The estimated incidence rates were 8/184,536 (4.3 per 100,000) woman-years at risk for users of combined OCs containing Levonorgestrel, 2/135,567 (1.5 per 100,000) for desogestrel users, and 5/105,201 (4.8 per 100,000) for gestodene users. The relative risk (RR) estimates were 0.4 (95% CI 0.1-2.1) and 1.4 (CI 0.5-4.5) for desogestrel and gestodene, respectively, compared with Levonorgestrel. In the second study, derived from some 370 general practices, there were 80 cases of nonfatal venous thromboembolism (VTE) in a cohort of 238,130 otherwise healthy women. The incidence rates of VTE per 100,000 woman-years at risk were 16.1 for Levonorgestrel users, 29.3 for desogestrel, and 28.1 for gestodene. The adjusted RR estimates from the cohort analysis were 1.9 (1.1-3.2) and 1.8 (1.0-3.2) for desogestrel and gestodene users, respectively, compared with users of Levonorgestrel. In a nested case-control analysis the adjusted matched RR estimates were 2.2 (1.1-4.4) and 2.1 (1.0-4.4) for desogestrel and gestodene users, respectively, compared with users of Levonorgestrel. The excess risk for nonfatal VTE associated with the new generation of combined OCs containing low-dose oestrogen and the progestagens desogestrel or gestodene compared with Levonorgestrel is estimated to be 16 per 100,000 woman-years.
Patrick F Kiser - One of the best experts on this subject based on the ideXlab platform.
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Engineering a segmented dual-reservoir polyurethane intravaginal ring for simultaneous prevention of HIV transmission and unwanted pregnancy. PLoS One 2014
2016Co-Authors: Justin T. Clark, Meredith R. Clark, Namdev B. Shelke, Todd J. Johnson, Eric M. Smith, Andrew K. Andreasen, Joel S. Nebeker, Judit Fabian, David R. Friend, Patrick F KiserAbstract:The HIV/AIDS pandemic and its impact on women prompt the investigation of prevention strategies to interrupt sexual transmission of HIV. Long-acting drug delivery systems that simultaneously protect womenfrom sexual transmission of HIV and unwanted pregnancy could be important tools in combating the pandemic. We describe the design, in silico, in vitro and in vivo evaluation of a dual-reservoir intravaginal ring that delivers the HIV-1 reverse transcriptase inhibitor tenofovir and the contraceptive Levonorgestrel for 90 days. Two polyether urethanes with two different hard segment volume fractions were used to make coaxial extruded reservoir segments with a 100 mm thick rate controlling membrane and a diameter of 5.5 mm that contain 1.3 wt % Levonorgestrel. A new mechanistic diffusion model accurately described the Levonorgestrel burst release in early time points and pseudo-steady state behavior at later time points. As previously described, tenofovir was formulated as a glycerol paste and filled into a hydrophilic polyurethane, hollow tube reservoir that was melt-sealed by induction welding. These tenofovir-eluting segments and 2 cm long coaxially extruded Levonorgestrel eluting segments were joined by induction welding to form rings that released an average of 7.5 mg tenofovir and 21 mg Levonorgestrel per day in vitro for 90 days. Levonorgestrel segments placed intravaginally in rabbits resulted in sustained, dose-dependent levels of Levonorgestrel in plasma and cervical tissue for 90 days. Polyurethane caps placed between segments successfully prevented diffusion of Levonorgestrel into the tenofovir-releasing segment during storage.Hydrate
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engineering a segmented dual reservoir polyurethane intravaginal ring for simultaneous prevention of hiv transmission and unwanted pregnancy
PLOS ONE, 2014Co-Authors: Justin T. Clark, Meredith R. Clark, Namdev B. Shelke, Todd J. Johnson, Andrew K. Andreasen, Joel S. Nebeker, Judit Fabian, David R. Friend, Eric Smith, Patrick F KiserAbstract:The HIV/AIDS pandemic and its impact on women prompt the investigation of prevention strategies to interrupt sexual transmission of HIV. Long-acting drug delivery systems that simultaneously protect womenfrom sexual transmission of HIV and unwanted pregnancy could be important tools in combating the pandemic. We describe the design, in silico, in vitro and in vivo evaluation of a dual-reservoir intravaginal ring that delivers the HIV-1 reverse transcriptase inhibitor tenofovir and the contraceptive Levonorgestrel for 90 days. Two polyether urethanes with two different hard segment volume fractions were used to make coaxial extruded reservoir segments with a 100 µm thick rate controlling membrane and a diameter of 5.5 mm that contain 1.3 wt% Levonorgestrel. A new mechanistic diffusion model accurately described the Levonorgestrel burst release in early time points and pseudo-steady state behavior at later time points. As previously described, tenofovir was formulated as a glycerol paste and filled into a hydrophilic polyurethane, hollow tube reservoir that was melt-sealed by induction welding. These tenofovir-eluting segments and 2 cm long coaxially extruded Levonorgestrel eluting segments were joined by induction welding to form rings that released an average of 7.5 mg tenofovir and 21 µg Levonorgestrel per day in vitro for 90 days. Levonorgestrel segments placed intravaginally in rabbits resulted in sustained, dose-dependent levels of Levonorgestrel in plasma and cervical tissue for 90 days. Polyurethane caps placed between segments successfully prevented diffusion of Levonorgestrel into the tenofovir-releasing segment during storage.Hydrated rings endured between 152 N and 354 N tensile load before failure during uniaxial extension testing. In summary, this system represents a significant advance in vaginal drug delivery technology, and is the first in a new class of long-acting multipurpose prevention drug delivery systems.
Susan S. Jick - One of the best experts on this subject based on the ideXlab platform.
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risk of venous thromboembolism in users of oral contraceptives containing drospirenone or Levonorgestrel nested case control study based on uk general practice research database
BMJ, 2011Co-Authors: Lianne Parkin, Katrina Sharples, Rohini K Hernandez, Susan S. JickAbstract:Objective To examine the risk of non-fatal idiopathic venous thromboembolism in current users of a combined oral contraceptive containing drospirenone, relative to current users of preparations containing Levonorgestrel. Design Nested case-control study. Setting UK General Practice Research Database. Participants Women aged 15-44 years without major risk factors for venous thromboembolism who started a new episode of use of an oral contraceptive containing 30 µg oestrogen in combination with either drospirenone or Levonorgestrel between May 2002 and September 2009. Cases were women with a first diagnosis of venous thromboembolism; up to four controls, matched by age, duration of recorded information, and general practice, were randomly selected for each case. Main outcome measures Odds ratios and 95% confidence intervals estimated with conditional logistic regression; age adjusted incidence rate ratio estimated with Poisson regression. Results 61 cases of idiopathic venous thromboembolism and 215 matched controls were identified. In the case-control analysis, current use of the drospirenone contraceptive was associated with a threefold higher risk of non-fatal idiopathic venous thromboembolism compared with Levonorgestrel use; the odds ratio adjusted for body mass index was 3.3 (95% confidence interval 1.4 to 7.6). Subanalyses suggested that referral, diagnostic, first time user, duration of use, and switching biases were unlikely explanations for this finding. The crude incidence rate was 23.0 (95% confidence interval 13.4 to 36.9) per 100 000 woman years in current users of drospirenone and 9.1 (6.6 to 12.2) per 100 000 woman years in current users of Levonorgestrel oral contraceptives. The age adjusted incidence rate ratio was 2.7 (1.5 to 4.7). Conclusions These findings contribute to emerging evidence that the combined oral contraceptive containing drospirenone carries a higher risk of venous thromboembolism than do formulations containing Levonorgestrel.
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risk of non fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing Levonorgestrel case control study using united states claims data
BMJ, 2011Co-Authors: Susan S. Jick, Rohini K HernandezAbstract:Objective To compare the risk of non-fatal venous thromboembolism in women receiving oral contraceptives containing drospirenone with that in women receiving oral contraceptives containing Levonorgestrel. Design Nested case-control and cohort study. Setting The study was based on information from PharMetrics, a United States based company that collects information on claims paid by managed care plans. Participants The study encompassed all women aged 15 to 44 years who received an oral contraceptive containing either drospirenone or Levonorgestrel after 1 January 2002. Cases were women with current use of a study oral contraceptive and a diagnosis of venous thromboembolism in the absence of identifiable clinical risk factors (idiopathic venous thromboembolism). Up to four controls were matched to each case by age and calendar time. Main outcome measures Odds ratios comparing the risk of non-fatal venous thromboembolism in users of the two contraceptives; incidence rates and rate ratios of non-fatal venous thromboembolism for users of each of the study contraceptives. Results 186 newly diagnosed, idiopathic cases of venous thromboembolism were identified in the study population and matched with 681 controls. In the case-control analysis, the conditional odds ratio for venous thromboembolism comparing use of oral contraceptives containing drospirenone with use of those containing Levonorgestrel was 2.3 (95% confidence interval 1.6 to 3.2). The incidence rates for venous thromboembolism in the study population were 30.8 (95% confidence interval 25.6 to 36.8) per 100 000 woman years among users of oral contraceptives containing drospirenone and 12.5 (9.61 to 15.9) per 100 000 woman years among users of oral contraceptives containing Levonorgestrel. The age adjusted incidence rate ratio for venous thromboembolism for current use of oral contraceptives containing drospirenone compared with those containing Levonorgestrel was 2.8 (2.1 to 3.8). Conclusions The risk of non-fatal venous thromboembolism among users of oral contraceptives containing drospirenone seems to be around twice that of users of oral contraceptives containing Levonorgestrel, after the effects of potential confounders and prescribing biases have been taken into account.
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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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Original research article Cerebral venous sinus thrombosis in users of four hormonal contraceptives: Levonorgestrel-containing oral contraceptives, norgestimate-containing oral contraceptives, desogestrel-containing oral contraceptives and the contra
2006Co-Authors: Susan S. Jick, Hershel JickAbstract: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 CVSTamong 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 Levonorgestrelcontaining OCs.
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risk of idiopathic cardiovascular death and rionfatal venous thromboembolism in women using oral contraceptives with differing progestagen components
The Lancet, 1995Co-Authors: Hershel Jick, Marian Wald Myers, Catherine Vasilakis, Susan S. Jick, Victor GurewichAbstract:Abstract Summary Concern about the risks of cardiovascular illness in women using combined oral contraceptives (OC) containing the progestagens desogestrel and gestodene prompted two studies of data from the UK General Practice Research Database. We compared the risks of certain cardiovascular illnesses in otherwise healthy women exposed to one of three OCs containing In the first study, based on some 470 general practices, there were 15 cases of unexpected idiopathic cardiovascular death among 303 470 women who were current users of one of the study OCs. The estimated incidence rates were 8/184 536 (4·3 per 100 000) woman-years at risk for users of combined OCs containing Levonorgestrel, 2/135567 (1·5 per 100 000) for desogestrel users, and 5/105 201 (4·8 per 100 000) for gestodene users. The relative risk (RR) estimates were 0·4 (95% Cl 0·1-2·1) and 1·4 (Cl 0·5-4·5) for desogestrel and gestodene, respectively, compared with Levonorgestrel. In the second study, derived from some 370 general practices, there were 80 cases of nonfatal venous thromboembolism (VTE) in a cohort of 238 130 otherwise healthy women. The incidence rates of VTE per 100 000 woman-years at risk were 16·1 for Levonorgestrel users, 29·3 for desogestrel, and 28·1 for gestodene. The adjusted RR estimates from the cohort analysis were 1·9 (1·1-3·2) and 1·8 (1·0-3·2) for desogestrel and gestodene users, respectively, compared with users of Levonorgestrel. In a nested case-control analysis the adjusted matched RR estimates were 2·2 (1·1-4·4) and 2·1 (1·0-4·4) for desogestrel and gestodene users, respectively, compared with users of Levonorgestrel. The excess risk for nonfatal VTE associated with the new generation of combined OCs containing low-dose oestrogen and the progestagens desogestrel or gestodene compared with Levonorgestrel is estimated to be 16 per 100 000 woman-years.
Justin T. Clark - One of the best experts on this subject based on the ideXlab platform.
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Engineering a segmented dual-reservoir polyurethane intravaginal ring for simultaneous prevention of HIV transmission and unwanted pregnancy. PLoS One 2014
2016Co-Authors: Justin T. Clark, Meredith R. Clark, Namdev B. Shelke, Todd J. Johnson, Eric M. Smith, Andrew K. Andreasen, Joel S. Nebeker, Judit Fabian, David R. Friend, Patrick F KiserAbstract:The HIV/AIDS pandemic and its impact on women prompt the investigation of prevention strategies to interrupt sexual transmission of HIV. Long-acting drug delivery systems that simultaneously protect womenfrom sexual transmission of HIV and unwanted pregnancy could be important tools in combating the pandemic. We describe the design, in silico, in vitro and in vivo evaluation of a dual-reservoir intravaginal ring that delivers the HIV-1 reverse transcriptase inhibitor tenofovir and the contraceptive Levonorgestrel for 90 days. Two polyether urethanes with two different hard segment volume fractions were used to make coaxial extruded reservoir segments with a 100 mm thick rate controlling membrane and a diameter of 5.5 mm that contain 1.3 wt % Levonorgestrel. A new mechanistic diffusion model accurately described the Levonorgestrel burst release in early time points and pseudo-steady state behavior at later time points. As previously described, tenofovir was formulated as a glycerol paste and filled into a hydrophilic polyurethane, hollow tube reservoir that was melt-sealed by induction welding. These tenofovir-eluting segments and 2 cm long coaxially extruded Levonorgestrel eluting segments were joined by induction welding to form rings that released an average of 7.5 mg tenofovir and 21 mg Levonorgestrel per day in vitro for 90 days. Levonorgestrel segments placed intravaginally in rabbits resulted in sustained, dose-dependent levels of Levonorgestrel in plasma and cervical tissue for 90 days. Polyurethane caps placed between segments successfully prevented diffusion of Levonorgestrel into the tenofovir-releasing segment during storage.Hydrate
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engineering a segmented dual reservoir polyurethane intravaginal ring for simultaneous prevention of hiv transmission and unwanted pregnancy
PLOS ONE, 2014Co-Authors: Justin T. Clark, Meredith R. Clark, Namdev B. Shelke, Todd J. Johnson, Andrew K. Andreasen, Joel S. Nebeker, Judit Fabian, David R. Friend, Eric Smith, Patrick F KiserAbstract:The HIV/AIDS pandemic and its impact on women prompt the investigation of prevention strategies to interrupt sexual transmission of HIV. Long-acting drug delivery systems that simultaneously protect womenfrom sexual transmission of HIV and unwanted pregnancy could be important tools in combating the pandemic. We describe the design, in silico, in vitro and in vivo evaluation of a dual-reservoir intravaginal ring that delivers the HIV-1 reverse transcriptase inhibitor tenofovir and the contraceptive Levonorgestrel for 90 days. Two polyether urethanes with two different hard segment volume fractions were used to make coaxial extruded reservoir segments with a 100 µm thick rate controlling membrane and a diameter of 5.5 mm that contain 1.3 wt% Levonorgestrel. A new mechanistic diffusion model accurately described the Levonorgestrel burst release in early time points and pseudo-steady state behavior at later time points. As previously described, tenofovir was formulated as a glycerol paste and filled into a hydrophilic polyurethane, hollow tube reservoir that was melt-sealed by induction welding. These tenofovir-eluting segments and 2 cm long coaxially extruded Levonorgestrel eluting segments were joined by induction welding to form rings that released an average of 7.5 mg tenofovir and 21 µg Levonorgestrel per day in vitro for 90 days. Levonorgestrel segments placed intravaginally in rabbits resulted in sustained, dose-dependent levels of Levonorgestrel in plasma and cervical tissue for 90 days. Polyurethane caps placed between segments successfully prevented diffusion of Levonorgestrel into the tenofovir-releasing segment during storage.Hydrated rings endured between 152 N and 354 N tensile load before failure during uniaxial extension testing. In summary, this system represents a significant advance in vaginal drug delivery technology, and is the first in a new class of long-acting multipurpose prevention drug delivery systems.
