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Andrew M Kaunitz - One of the best experts on this subject based on the ideXlab platform.

  • current options for injectable contraception in the united states
    Seminars in Reproductive Medicine, 2001
    Co-Authors: Andrew M Kaunitz
    Abstract:

    Two injectable forms of hormonal contraception depot medroxyprogesterone acetate (DMPA Depo-Provera) and medroxyprogesterone acetate/Estradiol Cypionate (MPA/E2C Lunelle) are now available to American women. Both formulations have demonstrated high degrees of efficacy safety and ease of use in international and U.S. trials. Data on DMPA have shown a number of noncontraceptive and therapeutic benefits the most prominent of which is an 80% reduction in the risk of endometrial cancer. Although such benefits are less documented for MPA/E2C they are expected to be similar to those seen with DMPA and oral contraceptives. Minor side effects of both formulations include menstrual irregularities in the early months of treatment and amenorrhea with DMPA. Patient counseling about the potential for these side effects as well as possible risks is important to long-term successful use of these contraceptive methods. (authors)

  • current options for injectable contraception in the united states
    Seminars in Reproductive Medicine, 2001
    Co-Authors: Andrew M Kaunitz
    Abstract:

    Two injectable forms of hormonal contraception depot medroxyprogesterone acetate (DMPA Depo-Provera) and medroxyprogesterone acetate/Estradiol Cypionate (MPA/E2C Lunelle) are now available to American women. Both formulations have demonstrated high degrees of efficacy safety and ease of use in international and U.S. trials. Data on DMPA have shown a number of noncontraceptive and therapeutic benefits the most prominent of which is an 80% reduction in the risk of endometrial cancer. Although such benefits are less documented for MPA/E2C they are expected to be similar to those seen with DMPA and oral contraceptives. Minor side effects of both formulations include menstrual irregularities in the early months of treatment and amenorrhea with DMPA. Patient counseling about the potential for these side effects as well as possible risks is important to long-term successful use of these contraceptive methods. (authors)

  • Bleeding patterns of women using Lunelle™ monthly contraceptive injections (medroxyprogesterone acetate and Estradiol Cypionate injectable suspension) compared with those of women using Ortho-Novum® 7/7/7 (norethindrone/ethinyl Estradiol triphasic) o
    Contraception, 2000
    Co-Authors: Roger J. Garceau, Charles J. Wajszczuk, Andrew M Kaunitz
    Abstract:

    Abstract Persistent and/or unpredictable bleeding is a common reason for discontinuation of hormonal contraceptive methods. An open-label, nonrandomized, parallel, controlled study compared the efficacy, safety, and cycle control of the new, highly efficacious monthly injectable contraceptive containing 25 mg medroxyprogesterone acetate (MPA) and 5 mg Estradiol Cypionate (E 2 C) (MPA/E 2 C) (Lunelle™ Monthly Contraceptive Injection) with that of the frequently used norethindrone 0.5, 0.75, 1.0 mg/0.035 mg ethinyl Estradiol (NET/EE) triphasic oral contraceptive (Ortho-Novum ® 7/7/7). This report directly compares the bleeding patterns of women on MPA/E 2 C to those of women on NET/EE and untreated women. Overall, breakthrough bleeding occurred less frequently in women using MPA/E 2 C than in women using NET/EE (p ≤0.01). However, more women using MPA/E 2 C experienced amenorrhea/missed periods than those on NET/EE (p ≤0.01). In addition, the percentage of women experiencing breakthrough bleeding or amenorrhea while using other oral contraceptives is compared to that of women using MPA/E 2 C. A rapidly reversible method, MPA/E 2 C, combines the high contraceptive efficacy of surgical sterilization with the convenience of monthly administration. These data suggest that, for a large proportion of women, MPA/E 2 C offers predictability in bleeding patterns comparable to or greater than that experienced by ovulatory untreated women or those using combination oral contraceptives.

  • Lunelle™ monthly contraceptive injection (medroxyprogesterone acetate and Estradiol Cypionate injectable suspension): a contraceptive method for women in the US and worldwide
    Contraception, 1999
    Co-Authors: Andrew M Kaunitz, Daniel R Mishell
    Abstract:

    This paper presents data from the first large US clinical trial of Lunelle monthly contraceptive injection which is a combination of 25 mg of medroxyprogesterone acetate (MPA) and 5 mg of Estradiol Cypionate (E2C). The lead article reports that there was no occurrence of unintended pregnancies and no contraceptive discontinuation among more than 700 women using the MPA/E2C in a 60-week clinical trial. Most women experienced regular monthly cycles the same as those women using the nonhormonal method. The second article reports the results of a separate trial that studied return ovulation after three monthly injections of MPA/E2C in surgically sterile women. Serum progesterone determinations found that return of ovulation was documented as early as 63 days after the third (final) intramuscular injection of MPA/E2C. Two articles in this issue assess the pharmacokinetics of MPA/E2C injections. Findings indicate that MPA/E2C represents a contraceptive option that combines the advantages of oral contraceptives with the convenience and effectiveness of monthly administration. Accordingly a US Food and Drug Administration approval should play an important role in helping women achieve effective birth control in the US and worldwide.

  • Comparative safety, efficacy, and cycle control of Lunelle™ monthly contraceptive injection (medroxyprogesterone acetate and Estradiol Cypionate injectable suspension) and Ortho-Novum® 7/7/7 oral contraceptive (norethindrone/ ethinyl Estradiol tripha
    Contraception, 1999
    Co-Authors: Andrew M Kaunitz, Roger J. Garceau, Matthew A Cromie
    Abstract:

    Abstract An open-label, nonrandomized, parallel, controlled study compared the efficacy, safety, and cycle control of a new monthly injectable contraceptive containing 25 mg of medroxyprogesterone acetate (MPA) and 5 mg of Estradiol Cypionate (E 2 C) (MPA/E 2 C) (Lunelle™ Monthly Contraceptive Injection) with that of a norethindrone 0.5, 0.75, 1.0 mg/0.035 mg ethinyl Estradiol (NET/EE) triphasic oral contraceptive (Ortho-Novum® 7/7/7). At study enrollment, women chose either the injections or the oral contraceptive. A higher proportion of women in the NET/EE group (65.1%) than in the MPA/E 2 C group (43.7%) had used hormonal contraception during the month before the study (p 2 C users and 67.6% (217/321) of NET/EE users completed the 60-week trial. One-year contraceptive efficacy (13 cycles of 28 days) for MPA/E 2 C and NET/EE was based on 8008 and 3434 woman-cycles of use, respectively. During the first year, one pregnancy occurred in an NET/EE user for a lifetable rate of 0.3; no pregnancies occurred in users of MPA/E 2 C. One additional pregnancy in the NET/EE group occurred during the 15th treatment cycle. After the first treatment cycle, women in both groups experienced regular menses, with an average cycle length of 28 days in MPA/E 2 C users and 27 days in NET/EE users. Although MPA/E 2 C users were more likely to experience bleeding irregularities, only 2.5% (19/775) cited metrorrhagia as a reason for discontinuing treatment. The adverse events reported in both treatment groups are consistent with those expected with the use of combined hormonal contraceptives. Overall, the results of this first Phase III US clinical trial of MPA/E 2 C confirm this method's high contraceptive efficacy and safety, as shown in previous studies by the World Health Organization. These results suggest that a monthly combination injectable would represent a welcome new contraceptive option for women in the US.

Matthew A Cromie - One of the best experts on this subject based on the ideXlab platform.

  • Comparative effects of Lunelle™ Monthly Contraceptive Injection (medroxyprogesterone acetate and Estradiol Cypionate injectable suspension) and Ortho-Novum® 7/7/7 oral contraceptive (norethindrone/ethinyl Estradiol triphasic) on lipid profiles
    Contraception, 2000
    Co-Authors: Matthew A Cromie, Marie H Maile, Charles J. Wajszczuk
    Abstract:

    Abstract As part of a 60-week, open-label, nonrandomized, parallel, controlled study comparing a monthly contraceptive injection containing medroxyprogesterone acetate (MPA) 25 mg and Estradiol Cypionate (E 2 C) 5 mg (Lunelle™ Monthly Contraceptive Injection) and a norethindrone 0.5, 0.75, 1.0 mg/0.035 mg ethinyl Estradiol (NET/EE) triphasic oral contraceptive (Ortho-Novum® 7/7/7), a longitudinal examination of lipid profiles was conducted. Lipid parameters were assessed at screening and at weeks 20, 40, and 60 (or the final visit) in 114 women using MPA/E 2 C and 93 using NET/EE (lipid analysis population). Extra blood samples were obtained at weeks 21, 22, and 23 in 61 MPA/E 2 C users and 51 NET/EE users (index-cycle analysis population) to investigate lipid changes during one cycle of use. In the index-cycle population, median changes from screening to week 60 showed a decrease in apolipoprotein (apo) A-I and apo A-II in both groups. MPA/E 2 C users had a decrease in total cholesterol (C), total triglycerides, low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), with maintenance of the total C/HDL-C ratio. NET/EE users showed an increase in total C and LDL-C, with no change in HDL-C or the total C/HDL-C ratio. Within the index cycle (weeks 20 to 23), median changes in lipid values in both MPA/E 2 C and NET/EE users were generally greatest during the first week after the injection or the start of the pill pack. The results of this first longitudinal examination of serum lipids in US women using MPA/E 2 C confirm earlier findings in women in other countries. However, a direct comparison of the effects of MPA/E 2 C and NET/EE on lipid profiles was not possible in this study because of its design and because of the baseline and pharmacokinetic/pharmacodynamic differences between the two contraceptive groups. The results of this analysis showed that, although overall lipid values decreased, including a significant decrease in HDL cholesterol, the maintenance of the total-C/HDL-C ratio suggests that the effect of MPA/E 2 C on lipid parameters may not negatively affect CVD risk over 1 year of use. However, these results warrant further investigation, given the nature of this trial.

  • Lunelle™ monthly contraceptive injection (medroxyprogesterone acetate and Estradiol Cypionate injectable suspension): effects of body weight and injection sites on pharmacokinetics
    Contraception, 1999
    Co-Authors: Mohamad H Rahimy, Matthew A Cromie, Nancy K. Hopkins, Donald M. Tong
    Abstract:

    Abstract A new contraceptive option, medroxyprogesterone acetate (MPA) and Estradiol Cypionate (E 2 C) (MPA/E 2 C, Lunelle™ Monthly Contraceptive Injection), will soon be available for women in the US. This article reports the results of a US trial that assessed the effects of body weight and injection site on the pharmacokinetics of MPA, the progestin mediating contraceptive efficacy. This assessment was part of a nonrandomized, open-label, multicenter US study in healthy women receiving a monthly injection of MPA/E 2 C for 60 weeks. A total of 77 women (aged 18–47 years) at four centers participated in the pharmacokinetics assessment during the sixth or the seventh injection. For determination of serum MPA concentration-time profiles, blood samples were collected before the sixth and seventh injections (day 0) and on days 3, 7, 14, 21, and 28 after the sixth and seventh monthly administrations. For effects of injection site, MPA pharmacokinetics were compared at injection sites of the arm, hip, and leg. The pharmacokinetics of MPA, determined at the sixth and seventh injection, were not significantly affected by injection sites. The mean area under the curve (AUC 0–28 ), however, was different between the arm and the leg injection sites; the difference was min ) at the fifth and sixth monthly injections were similar (range 0.42–0.51 ng/mL) for the three injection sites and well above the threshold levels of 0.10–0.20 ng/mL required to suppress ovulation. For effects of body mass index (BMI) on pharmacokinetics, women were stratified into three groups: thin/normal (BMI 18–28, n=48), obese (BMI 29–38, n=23), and highly obese (BMI > 38, n=6). There were no significant differences in the pharmacokinetics of MPA among the three BMI categories. The only significant difference (p = 0.0387) was the AUC 0–28 between BMI 18–28 and BMI 29–38. Because of the small sample size in the highly obese group, a reanalysis was performed by pooling subjects of the obese and highly obese groups. Results of the pooled statistical analysis remained the same. In summary, these results suggest that minor differences observed in the MPA pharmacokinetics—whether due to injection site or body weight or both—have no impact on the contraceptive efficacy of MPA/E 2 C, as trough concentrations (C min ) are well above the threshold levels required to suppress ovulation. No dose adjustment is necessary based on body weight or injection site.

  • Comparative safety, efficacy, and cycle control of Lunelle™ monthly contraceptive injection (medroxyprogesterone acetate and Estradiol Cypionate injectable suspension) and Ortho-Novum® 7/7/7 oral contraceptive (norethindrone/ ethinyl Estradiol tripha
    Contraception, 1999
    Co-Authors: Andrew M Kaunitz, Roger J. Garceau, Matthew A Cromie
    Abstract:

    Abstract An open-label, nonrandomized, parallel, controlled study compared the efficacy, safety, and cycle control of a new monthly injectable contraceptive containing 25 mg of medroxyprogesterone acetate (MPA) and 5 mg of Estradiol Cypionate (E 2 C) (MPA/E 2 C) (Lunelle™ Monthly Contraceptive Injection) with that of a norethindrone 0.5, 0.75, 1.0 mg/0.035 mg ethinyl Estradiol (NET/EE) triphasic oral contraceptive (Ortho-Novum® 7/7/7). At study enrollment, women chose either the injections or the oral contraceptive. A higher proportion of women in the NET/EE group (65.1%) than in the MPA/E 2 C group (43.7%) had used hormonal contraception during the month before the study (p 2 C users and 67.6% (217/321) of NET/EE users completed the 60-week trial. One-year contraceptive efficacy (13 cycles of 28 days) for MPA/E 2 C and NET/EE was based on 8008 and 3434 woman-cycles of use, respectively. During the first year, one pregnancy occurred in an NET/EE user for a lifetable rate of 0.3; no pregnancies occurred in users of MPA/E 2 C. One additional pregnancy in the NET/EE group occurred during the 15th treatment cycle. After the first treatment cycle, women in both groups experienced regular menses, with an average cycle length of 28 days in MPA/E 2 C users and 27 days in NET/EE users. Although MPA/E 2 C users were more likely to experience bleeding irregularities, only 2.5% (19/775) cited metrorrhagia as a reason for discontinuing treatment. The adverse events reported in both treatment groups are consistent with those expected with the use of combined hormonal contraceptives. Overall, the results of this first Phase III US clinical trial of MPA/E 2 C confirm this method's high contraceptive efficacy and safety, as shown in previous studies by the World Health Organization. These results suggest that a monthly combination injectable would represent a welcome new contraceptive option for women in the US.

Mohamad H Rahimy - One of the best experts on this subject based on the ideXlab platform.

  • lunelle monthly contraceptive injection medroxyprogesterone acetate and Estradiol Cypionate injectable suspension steady state pharmacokinetics of mpa and e2 in surgically sterile women
    Contraception, 1999
    Co-Authors: Mohamad H Rahimy, Kristi K Ryan, Nancy K. Hopkins
    Abstract:

    The steady-state pharmacokinetics and pharmacodynamics of medroxyprogesterone acetate (MPA) and Estradiol (E2, released from E2C by esterase enzymes) were characterized after administration to surgically sterile women. This report describes the pharmacokinetics of this multiple-dose and open-labeled study (pharmacodynamics are reported in a subsequent article in this issue). Women with regular menstrual cycles were studied for one control cycle, 3 consecutive treatment months, and 3–5 months of follow-up. Blood samples were drawn before each monthly dose and at specified time points after the third monthly injection. A total of 16 women were enrolled, 14 of whom completed the study. These 14 women (13 white, one black) ranged in age from 28 to 43.4 years, in body weight from 47.6 to 68.9 kg, and in height from 150 to 175 cm. Mean serum MPA concentrations peaked in the first week after administration of MPA/E2C (Lunelle™ Monthly Contraceptive Injection). The mean MPA Cmax and AUC0−t(last) were 1.25 ng/mL and 32.13 ng · day/mL, respectively. Serum MPA concentrations declined with a mean terminal half-life of 14.7 days, indicating that absorption from the injection site is prolonged after administration of MPA/E2C. The time for MPA concentrations to fall below the lower limit of quantitation (i.e., <10 pg/mL) after the third injection ranged from 63 to 84 days. The average MPA trough (Cmin, day 28) concentrations for the three consecutive monthly injections ranged from 0.44 to 0.47 pg/mL, indicating that steady-state conditions were achieved after the first injection. The MPA Cmin values were well above threshold levels required to suppress ovulation throughout the injection interval. Absorption of E2 from the injection site was also prolonged after injection of MPA/E2C. Mean concentrations of E2 peaked at approximately 2 days after the third injection, and the average Cmax was 247 pg/mL. Serum E2 levels declined with a terminal half-life of approximately 8 days; E2 levels returned to baseline (typically, approximately 100 pg/mL) by 14 days after each injection. The average trough (Cmin, day 28) levels for E2 ranged from 40 to 55 pg/mL. The results of this study demonstrate that steady-state conditions are achieved after the first injection of MPA/E2C; no further MPA or E2 accumulation occurs beyond the first injection. Furthermore, the E2 peak observed after injection of MPA/E2C is similar to the nontreated preovulatory E2 range and returns to baseline levels by approximately 14 days after injection.

  • Lunelle™ monthly contraceptive injection (medroxyprogesterone acetate and Estradiol Cypionate injectable suspension): effects of body weight and injection sites on pharmacokinetics
    Contraception, 1999
    Co-Authors: Mohamad H Rahimy, Matthew A Cromie, Nancy K. Hopkins, Donald M. Tong
    Abstract:

    Abstract A new contraceptive option, medroxyprogesterone acetate (MPA) and Estradiol Cypionate (E 2 C) (MPA/E 2 C, Lunelle™ Monthly Contraceptive Injection), will soon be available for women in the US. This article reports the results of a US trial that assessed the effects of body weight and injection site on the pharmacokinetics of MPA, the progestin mediating contraceptive efficacy. This assessment was part of a nonrandomized, open-label, multicenter US study in healthy women receiving a monthly injection of MPA/E 2 C for 60 weeks. A total of 77 women (aged 18–47 years) at four centers participated in the pharmacokinetics assessment during the sixth or the seventh injection. For determination of serum MPA concentration-time profiles, blood samples were collected before the sixth and seventh injections (day 0) and on days 3, 7, 14, 21, and 28 after the sixth and seventh monthly administrations. For effects of injection site, MPA pharmacokinetics were compared at injection sites of the arm, hip, and leg. The pharmacokinetics of MPA, determined at the sixth and seventh injection, were not significantly affected by injection sites. The mean area under the curve (AUC 0–28 ), however, was different between the arm and the leg injection sites; the difference was min ) at the fifth and sixth monthly injections were similar (range 0.42–0.51 ng/mL) for the three injection sites and well above the threshold levels of 0.10–0.20 ng/mL required to suppress ovulation. For effects of body mass index (BMI) on pharmacokinetics, women were stratified into three groups: thin/normal (BMI 18–28, n=48), obese (BMI 29–38, n=23), and highly obese (BMI > 38, n=6). There were no significant differences in the pharmacokinetics of MPA among the three BMI categories. The only significant difference (p = 0.0387) was the AUC 0–28 between BMI 18–28 and BMI 29–38. Because of the small sample size in the highly obese group, a reanalysis was performed by pooling subjects of the obese and highly obese groups. Results of the pooled statistical analysis remained the same. In summary, these results suggest that minor differences observed in the MPA pharmacokinetics—whether due to injection site or body weight or both—have no impact on the contraceptive efficacy of MPA/E 2 C, as trough concentrations (C min ) are well above the threshold levels required to suppress ovulation. No dose adjustment is necessary based on body weight or injection site.

  • Lunelle monthly contraceptive injection (medroxyprogesterone acetate and Estradiol Cypionate injectable suspension): assessment of return of ovulation after three monthly injections in surgically sterile women.
    Contraception, 1999
    Co-Authors: Mohamad H Rahimy, Kristi K Ryan
    Abstract:

    Abstract The pharmacodynamic effects of medroxyprogesterone acetate (MPA) and Estradiol Cypionate (E 2 C) (MPA/E 2 C) (Lunelle™ Monthly Contraceptive Injection) on ovarian function were assessed through changes in serum progesterone concentrations. The data described here were obtained simultaneously with pharmacokinetic data presented in another article in this issue. Sixteen surgically sterile women with regular menstrual cycles were studied for one control cycle, three consecutive treatment months, and 3–5 months of follow-up. Suppression, followed by resumption of ovulation (the dynamic end point), was assessed by serum progesterone levels. Return of ovulation was presumptive based on progesterone concentrations ≥4.7 ng/mL, as ultrasound was not used to determine the follicular/ovulatory status of these subjects. Luteal-like serum progesterone peaks were observed in all 16 women before drug administration, confirming the presence of ovulatory cycles. After the third monthly injection of MPA/E 2 C, progesterone concentrations were measured until demonstration of ovulation. Two women discontinued and three were lost to follow-up before this objective was achieved. Serum progesterone levels and, consequently, ovulation were suppressed beyond the entire dosing interval, indicated by the absence of any luteal-like progesterone peaks (serum progesterone concentrations did not exceed 1 ng/mL). The first normal ovulatory cycle, based on progesterone concentrations ≥4.7 ng/mL, was observed in 11 women between days 63 and 112 after the third injection. Select medroxyprogesterone acetate parameters (i.e., area under the curve and minimum concentration) were correlated with return of ovulation. The correlation coefficients (r) were 0.757 and 0.492 for area under the curve and minimum concentration, respectively, indicating that return of ovulation is dependent, in part, on area under the curve and on the magnitude of the serum MPA trough level. In general, the higher the minimum concentration levels, the longer the time to return of ovulation. In conclusion, the return of ovulation, as confirmed by serum progesterone concentrations ≥4.7 ng/mL, was observed as early as 63 days after the third and final monthly intramuscular injection of MPA/E 2 C, suggesting that consistent suppression of the hypothalamic-pituitary-ovarian axis is reversible after discontinuation of dosing.

Charles J. Wajszczuk - One of the best experts on this subject based on the ideXlab platform.

  • Bleeding patterns of women using Lunelle™ monthly contraceptive injections (medroxyprogesterone acetate and Estradiol Cypionate injectable suspension) compared with those of women using Ortho-Novum® 7/7/7 (norethindrone/ethinyl Estradiol triphasic) o
    Contraception, 2000
    Co-Authors: Roger J. Garceau, Charles J. Wajszczuk, Andrew M Kaunitz
    Abstract:

    Abstract Persistent and/or unpredictable bleeding is a common reason for discontinuation of hormonal contraceptive methods. An open-label, nonrandomized, parallel, controlled study compared the efficacy, safety, and cycle control of the new, highly efficacious monthly injectable contraceptive containing 25 mg medroxyprogesterone acetate (MPA) and 5 mg Estradiol Cypionate (E 2 C) (MPA/E 2 C) (Lunelle™ Monthly Contraceptive Injection) with that of the frequently used norethindrone 0.5, 0.75, 1.0 mg/0.035 mg ethinyl Estradiol (NET/EE) triphasic oral contraceptive (Ortho-Novum ® 7/7/7). This report directly compares the bleeding patterns of women on MPA/E 2 C to those of women on NET/EE and untreated women. Overall, breakthrough bleeding occurred less frequently in women using MPA/E 2 C than in women using NET/EE (p ≤0.01). However, more women using MPA/E 2 C experienced amenorrhea/missed periods than those on NET/EE (p ≤0.01). In addition, the percentage of women experiencing breakthrough bleeding or amenorrhea while using other oral contraceptives is compared to that of women using MPA/E 2 C. A rapidly reversible method, MPA/E 2 C, combines the high contraceptive efficacy of surgical sterilization with the convenience of monthly administration. These data suggest that, for a large proportion of women, MPA/E 2 C offers predictability in bleeding patterns comparable to or greater than that experienced by ovulatory untreated women or those using combination oral contraceptives.

  • Comparative effects of Lunelle™ Monthly Contraceptive Injection (medroxyprogesterone acetate and Estradiol Cypionate injectable suspension) and Ortho-Novum® 7/7/7 oral contraceptive (norethindrone/ethinyl Estradiol triphasic) on lipid profiles
    Contraception, 2000
    Co-Authors: Matthew A Cromie, Marie H Maile, Charles J. Wajszczuk
    Abstract:

    Abstract As part of a 60-week, open-label, nonrandomized, parallel, controlled study comparing a monthly contraceptive injection containing medroxyprogesterone acetate (MPA) 25 mg and Estradiol Cypionate (E 2 C) 5 mg (Lunelle™ Monthly Contraceptive Injection) and a norethindrone 0.5, 0.75, 1.0 mg/0.035 mg ethinyl Estradiol (NET/EE) triphasic oral contraceptive (Ortho-Novum® 7/7/7), a longitudinal examination of lipid profiles was conducted. Lipid parameters were assessed at screening and at weeks 20, 40, and 60 (or the final visit) in 114 women using MPA/E 2 C and 93 using NET/EE (lipid analysis population). Extra blood samples were obtained at weeks 21, 22, and 23 in 61 MPA/E 2 C users and 51 NET/EE users (index-cycle analysis population) to investigate lipid changes during one cycle of use. In the index-cycle population, median changes from screening to week 60 showed a decrease in apolipoprotein (apo) A-I and apo A-II in both groups. MPA/E 2 C users had a decrease in total cholesterol (C), total triglycerides, low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), with maintenance of the total C/HDL-C ratio. NET/EE users showed an increase in total C and LDL-C, with no change in HDL-C or the total C/HDL-C ratio. Within the index cycle (weeks 20 to 23), median changes in lipid values in both MPA/E 2 C and NET/EE users were generally greatest during the first week after the injection or the start of the pill pack. The results of this first longitudinal examination of serum lipids in US women using MPA/E 2 C confirm earlier findings in women in other countries. However, a direct comparison of the effects of MPA/E 2 C and NET/EE on lipid profiles was not possible in this study because of its design and because of the baseline and pharmacokinetic/pharmacodynamic differences between the two contraceptive groups. The results of this analysis showed that, although overall lipid values decreased, including a significant decrease in HDL cholesterol, the maintenance of the total-C/HDL-C ratio suggests that the effect of MPA/E 2 C on lipid parameters may not negatively affect CVD risk over 1 year of use. However, these results warrant further investigation, given the nature of this trial.

Roger J. Garceau - One of the best experts on this subject based on the ideXlab platform.

  • Bleeding patterns of women using Lunelle™ monthly contraceptive injections (medroxyprogesterone acetate and Estradiol Cypionate injectable suspension) compared with those of women using Ortho-Novum® 7/7/7 (norethindrone/ethinyl Estradiol triphasic) o
    Contraception, 2000
    Co-Authors: Roger J. Garceau, Charles J. Wajszczuk, Andrew M Kaunitz
    Abstract:

    Abstract Persistent and/or unpredictable bleeding is a common reason for discontinuation of hormonal contraceptive methods. An open-label, nonrandomized, parallel, controlled study compared the efficacy, safety, and cycle control of the new, highly efficacious monthly injectable contraceptive containing 25 mg medroxyprogesterone acetate (MPA) and 5 mg Estradiol Cypionate (E 2 C) (MPA/E 2 C) (Lunelle™ Monthly Contraceptive Injection) with that of the frequently used norethindrone 0.5, 0.75, 1.0 mg/0.035 mg ethinyl Estradiol (NET/EE) triphasic oral contraceptive (Ortho-Novum ® 7/7/7). This report directly compares the bleeding patterns of women on MPA/E 2 C to those of women on NET/EE and untreated women. Overall, breakthrough bleeding occurred less frequently in women using MPA/E 2 C than in women using NET/EE (p ≤0.01). However, more women using MPA/E 2 C experienced amenorrhea/missed periods than those on NET/EE (p ≤0.01). In addition, the percentage of women experiencing breakthrough bleeding or amenorrhea while using other oral contraceptives is compared to that of women using MPA/E 2 C. A rapidly reversible method, MPA/E 2 C, combines the high contraceptive efficacy of surgical sterilization with the convenience of monthly administration. These data suggest that, for a large proportion of women, MPA/E 2 C offers predictability in bleeding patterns comparable to or greater than that experienced by ovulatory untreated women or those using combination oral contraceptives.

  • Comparative safety, efficacy, and cycle control of Lunelle™ monthly contraceptive injection (medroxyprogesterone acetate and Estradiol Cypionate injectable suspension) and Ortho-Novum® 7/7/7 oral contraceptive (norethindrone/ ethinyl Estradiol tripha
    Contraception, 1999
    Co-Authors: Andrew M Kaunitz, Roger J. Garceau, Matthew A Cromie
    Abstract:

    Abstract An open-label, nonrandomized, parallel, controlled study compared the efficacy, safety, and cycle control of a new monthly injectable contraceptive containing 25 mg of medroxyprogesterone acetate (MPA) and 5 mg of Estradiol Cypionate (E 2 C) (MPA/E 2 C) (Lunelle™ Monthly Contraceptive Injection) with that of a norethindrone 0.5, 0.75, 1.0 mg/0.035 mg ethinyl Estradiol (NET/EE) triphasic oral contraceptive (Ortho-Novum® 7/7/7). At study enrollment, women chose either the injections or the oral contraceptive. A higher proportion of women in the NET/EE group (65.1%) than in the MPA/E 2 C group (43.7%) had used hormonal contraception during the month before the study (p 2 C users and 67.6% (217/321) of NET/EE users completed the 60-week trial. One-year contraceptive efficacy (13 cycles of 28 days) for MPA/E 2 C and NET/EE was based on 8008 and 3434 woman-cycles of use, respectively. During the first year, one pregnancy occurred in an NET/EE user for a lifetable rate of 0.3; no pregnancies occurred in users of MPA/E 2 C. One additional pregnancy in the NET/EE group occurred during the 15th treatment cycle. After the first treatment cycle, women in both groups experienced regular menses, with an average cycle length of 28 days in MPA/E 2 C users and 27 days in NET/EE users. Although MPA/E 2 C users were more likely to experience bleeding irregularities, only 2.5% (19/775) cited metrorrhagia as a reason for discontinuing treatment. The adverse events reported in both treatment groups are consistent with those expected with the use of combined hormonal contraceptives. Overall, the results of this first Phase III US clinical trial of MPA/E 2 C confirm this method's high contraceptive efficacy and safety, as shown in previous studies by the World Health Organization. These results suggest that a monthly combination injectable would represent a welcome new contraceptive option for women in the US.