Μg Levonorgestrel Research Articles

Efficacy and safety of a low-dose monophasic combination oral contraceptive containing 100 μg levonorgestrel and 20 μg ethinyl estradiol (Alesse ®)

The efficacy and safety of a low-dose 21-day combination oral contraceptive containing 100 μg levonorgestrel and 20 μg ethinyl estradiol were evaluated in an open-label, multicenter trial. A total of 1708 subjects with regular menstrual cycles (27,011 cycles) were evaluated. The oral contraceptive was administered once a day for 21 days, followed by 7 days of placebo for a complete cycle. During 26,554 cycles evaluated for efficacy, 18 pregnancies occurred (Pearl index of 0.88); 6 of these events were attributable to subject noncompliance. After 30 cycles of exposure the cumulative rate of withdrawal as a result of accidental pregnancy was 1.9%. Breakthrough bleeding (with or without spotting) occurred in 12.9% of the cycles and spotting alone occurred in 10.1% of the cycles. The 2 most common adverse events cited as reasons for discontinuation were headache (2% of subjects) and metrorrhagia (2%). One serious event led to withdrawal of a subject. Overall, the results of this study demonstrate that the monophasic regimen of 100 μg levonorgestrel and 20 μg ethinyl estradiol offers effective contraception, acceptable cycle control, and a good tolerability profile. (Am J Obstet Gynecol 1999;181:S39-44.)

A multicenter randomized comparison of cycle control and laboratory findings with oral contraceptive agents containing 100 μg levonorgestrel with 20 μg ethinyl estradiol or triphasic norethindrone with ethinyl estradiol

Objective: This study was undertaken to compare the effects of 2 oral contraceptive regimens on menstrual cycle control and laboratory findings. Methods: In a multicenter randomized study 100 μg levonorgestrel with 20 μg ethinyl estradiol (Alesse or Loette) was given to 155 healthy women. A triphasic preparation of 500, 750, and 1000 μg norethindrone with 35 μg ethinyl estradiol (Ortho-Novum 7/7/7 or TriNovum) was given to 167 women for 1 to 4 cycles of treatment. Results: Overall, the percentages of normal menstrual cycles and the percentages of cycles with intermenstrual and withdrawal bleeding were similar between the 2 treatment groups. In the levonorgestrel with ethinyl estradiol group, there was a statistically significantly longer latent period and a statistically significantly shorter withdrawal bleeding episode. Adverse events were similar between treatment groups, and none were serious. Most mean changes from baseline laboratory values were comparable between groups, although the mean increase in cholesterol concentration was statistically significantly lower in the levonorgestrel with ethinyl estradiol group. Changes in triglyceride and glucose concentrations were not statistically significantly different between groups. Conclusions: Levonorgestrel (100 μg) with ethinyl estradiol (20 μg) provides menstrual cycle control equivalent to that obtained with triphasic norethindrone with ethinyl estradiol (75% higher estrogen dose) with similar safety and tolerability. (Am J Obstet Gynecol 1999;181:S45-52.)

The effects of a low-dose monophasic preparation of levonorgestrel and ethinyl estradiol on coagulation and other hemostatic factors

Objective: This study was undertaken to evaluate the effects on hemostatic factors of a low-dose preparation of levonorgestrel and ethinyl estradiol in a 12-cycle study. Study Design: Thirty healthy women began taking 100 μg levonorgestrel and 20 μg ethinyl estradiol on the first day of the menstrual cycle, continued to take the preparation for the next 21 days, and then took placebo for 7 days. Mean changes in prothrombin time, partial thromboplastin time, and levels of factors VII and X, antithrombin, plasminogen, fibrinogen, protein S, thrombin-antithrombin complexes, and D-dimer were analyzed at baseline and at cycles 3, 6, and 12 with paired Student t tests. Results: Factor X, plasminogen antigen and activity, and D-dimer levels were significantly increased ( P ≤ .01) during all 3 cycle periods. Antithrombin antigen and protein S total antigen levels were significantly ( P ≤ .001 ) decreased at cycles 3, 6, and 12, whereas factor VII and protein S activity levels were significantly ( P ≤ .05) decreased at cycle 3 and at cycles 3 and 6, respectively. Conclusion: The effects on hemostatic factors in healthy women of a monophasic preparation of 100 μg levonorgestrel and 20 μg ethinyl estradiol were similar to those of other low-dose oral contraceptives. (Am J Obstet Gynecol 1999;181:S63-6.)

The effects of oral contraceptive use on iron and copper concentrations in breast milk

Objective: To determine the effects of oral contraceptive (OC) treatment on maternal iron and copper metabolism during lactation.Design: Observational study.Setting: Private and public clinics in Brazil.Patient(s): Lactating mothers attending the family planning clinic of the University of Brasilia.Intervention(s): The OCs used were a combination pill (0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol) and a minipill (0.35 mg of norethidrone). Blood and breast milk samples were collected before and after a measured period of OC treatment.Main Outcome Measure(s): Iron and copper concentrations were studied in the serum and breast milk of 54 breast-feeding mothers who had been advised by their physicians to use an OC, and in a control group.Result(s): Regression analysis was performed using a model that took into consideration socioeconomic status, number of children, duration of previous lactation, type of OC, length of treatment, and age. Repeated measurements (before and after OC treatment) showed that only copper concentrations in breast milk were significantly affected by stage of lactation. During the study period, which varied from 2–15 weeks, the decline in iron concentrations in breast milk was negligible, whereas copper concentrations decreased by 50%.Conclusion(s): The use of OCs does not appear to affect significantly the secretion of iron and copper in breast milk during the first 6 months of lactation.

Cycle control with oral contraceptives containing 20 μg of ethinyl estradiol: A multicenter, randomized comparison of levonorgestrel/ethinyl estradiol (100 μg/20 μg) and norethindrone/ethinyl estradiol (1000 μg/20 μg)

A randomized, open-label, multicenter study was undertaken to compare the effects of oral contraceptives (OC) containing 100 μg levonorgestrel (LNG)/20 μg ethinyl estradiol (EE) (Aless®/Loette®) and 1000 μg norethindrone acetate (NETA)/20 μg EE (Loestrin Fe 1/20®) on menstrual cycle control over four cycles of use. A total of 84 evaluable women provided 274 cycles of exposure in the LNG/EE group, and 89 women provided 289 cycles of exposure in the NETA/EE group. Overall, the LNG/EE group achieved a consistently higher percentage of normal menstrual cycles as well as a lower rate of intermenstrual bleeding and amenorrhea than the NETA/EE group. In cycle 4, 63.8% of cycles were normal in the LNG/EE group compared with 41.9% in the NETA/EE group (p < 0.005). Of the total cycles in the NETA/EE group, 10% were amenorrheic, compared with 1.1% in the LNG/EE group. The occurrence of bleeding and/or spotting was significantly lower in cycles 2 and 3 in the LNG/EE group (41.7% and 34.8%, respectively) compared with the NETA/EE group (62.3% and 56.3%; p < 0.05). Other cycle variables were generally similar between groups, as was the incidence of adverse events. These results demonstrate that good cycle control was achieved with an OC containing 20 μg EE and that 100 μg LNG/20 μg EE produces better cycle control than 1000 μg NETA/20 μg EE.

Large observational trial of a new low-dose oral contraceptive containing 20 μg ethinylestradiol and 100 μg levonorgestrel (Miranovar`) in Germany

The aim of this observational trial was to obtain clinical data from a large cohort of women using the new low-dose contraceptive (Miranovar`) and therefore to eliminate the restrictions which are normally present in clinical studies. Data were gathered in a clinical practice setting regarding cycle control and tolerance from women who were using Miranova (20 μg ethinylestradiol and 100 μg levonorgestrel). A total of 13 085 subjects were initially evaluated for this observational trial; data were available for 12 843 subjects during the treatment cycles. A total of 10 736 subjects (84.2%) completed all six treatment cycles. The method failure (Pearl index), calculated for 70 796 cycles, was 0.44. Cycle control was considered good during the trial; the length of cycle, duration of withdrawal bleeding and intensity of withdrawal bleeding did not significantly change during treatment. Intracyclic bleeding occurred mainly in the first cycle (31.4%) and declined significantly thereafter to a value of 14.5% in the third cycle. In the sixth (final) cycle, the intracyclic bleeding rate was 7.0%. There were no clinically relevant changes in mean systolic blood pressure, mean diastolic blood pressure or body weight. Miranova was shown to be an effective, well-tolerated oral contraceptive with good cycle control.

International clinical experience with a new low-dose, Monophasic oral contraceptive containing levonorgestrel 100 μg and ethinyl estradiol 20 μg

Manufacturers have steadily been decreasing the amounts of estrogen and progestin in oral contraceptives (OCs) in an effort to enhance safety and tolerability while preserving contraceptive efficacy. A new formulation containing 20 μg ethinyl estradiol (EE) and 100 μg levonorgestrel (LNG)—representing the lowest available contraceptive dose of each hormone—has undergone extensive clinical testing in the United States and Germany. A total of 1590 women in 61 centers received 20 μg EE and 100 μg LNG for 6 cycles. Overall, 4 pregnancies possibly related to treatment failure were reported, reflecting an overall Pearl Index (number of pregnancies per 100 woman-years of treatment) of 0.65 and a failure rate of 0.34%. Cycle control was typical of low-dose OC use. Spotting and break-through bleeding occurred most commonly during the earlier cycles in each study. Adverse events were typical of those seen with OC use and led to study discontinuation in 6.6% of the women. Intermenstrual bleeding was the cause for early study withdrawal in 2.6% of women. The study results suggest that the combination of 20 μg EE and 100 μg LNG offers the benefits of low hormone content with good contraceptive efficacy, cycle control, and tolerability.

A randomized controlled double-blind study of the effects on hemostasis of two progestogen-only pills containing 75 μg desogestrel or 30 μg levonorgestrel

The effects of two progestogen-only pills containing either 75 μg desogestrel (DSG) or 30 μg levonorgestrel (LNG) on hemostasis were investigated in a double-blind, randomized, controlled study of seven treatment cycles in 78 healthy women. DSG reduced factor VII activity (p <0.05) and prothrombin fragment 1+2 (p <0.05) and increased protein S (p <0.001). LNG reduced factor VII activity (p < 0.01) and plasminogen activity (p <0.01) and increased tissue-plasminogen activator (t-PA) (p <0.05). At the end of the post-treatment cycle with DSG, protein S (p <0.01) and t-PA (p <0.05) were increased and plasminogen activity was decreased (p <0.05), whereas with LNG, t-PA was increased (p <0.001) and prothrombin fragment 1+2 (p <0.05) and plasminogen activity (p <0.001) were decreased. Between-group comparisons revealed higher values for DSG regarding the anticoagulatory parameter protein S at cycle 7 (p <0.01) and post-treatment assessments (p <0.05), and the fibrinolytic parameter plasmin-antiplasmin complex was higher with DSG at cycle 7 (p <0.05) and at post-treatment (p <0.05). Both preparations had comparable and potentially favorable effects on hemostasis, and may offer suitable hormonal contraception to women with a personal or family history of venous thromboembolic diseases.

A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel over six treatment cycles

The aim of the trial was to demonstrate the contraceptive efficacy of a new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel and to observe cycle control and safety. Data from 805 treated women resulted in 4400 treatment cycles. One pregnancy occurred while on the trial medication as a result of method failure, resulting in a Pearl index of 0.29. Cycle control was good, and cycle length as well as duration and intensity of withdrawal bleeding were not significantly changed during the trial. Intermenstrual bleeding usually occurred as spotting and decreased considerably during the treatment phase. Spotting alone was reported in 12.4% of cycles, breakthrough bleeding alone in 4.5% of cycles, and breakthrough bleeding and spotting together in 1.4% of treatment cycles. The rate of absence of withdrawal bleeding declined throughout the trial to 2.4% in cycle 6. There were no serious adverse events related to treatment, and most adverse events were those commonly observed in clinical trials with oral contraceptives. Headache, breast tension, and nausea were reported by 17.3%, 11.0%, and 7.7% of the women, respectively. There were no clinically relevant changes in laboratory parameters, blood pressure, or weight. In this trial, the new low dose oral contraceptive containing 20 μg ethinyl estradiol and 100 μg levonorgestrel was shown to be effective, safe, and well tolerated. Cycle control was found to be good and there was a low incidence of adverse events.

Short-term treatment with levonorgestrel does not antagonize the ethinyl estradiol-induced increase of uterine blood flow in postmenopausal women

The aim of this study was to determine the effect of a short-term ethinyl estradiol/levonorgestrel medication on blood flow in the uterine arteries in postmenopausal women in a prospective placebo-controlled double-blind study. Twenty-one healthy postmenopausal woman at least 2 years after menopause received 60 μg ethinyl estradiol (EE) for 14 days followed by 40 μg EE plus 125 μg levonorgestrel (LNG) for 12 days (total treatment period 26 days). Sonographically, uterine volume, endometrial thickness, and blood flow in the uterine arteries [as reflected by pulsatility (PI) and resistance indices (RI)] were measured. Uterine size increased from 44 to 80 mL (day 14, p <0.001) and 87 mL (day 26, p = NS). Endometrium grew from 3 to 8 mm (day 14, p <0.001) and 11 mm (day 26, p = NS). Uterine arterial PI fell from 2.76 to 1.37 (day 14, p <0.001) and 1.34 (day 26, p = NS), whereas RI fell from 0.9 to 0.68 (day 14 and day 26, p <0.001). In conclusion, short-term treatment with LNG does not antagonize the vascular effect of EE on the uterine arteries as reflected by PI and RI. This result might have clinical significance in the selection of the progestin used in hormonal replacement therapy.

A Double‐Blind, Placebo‐Controlled Study on the Effect of Vigabatrin on In Vivo Parameters of Hepatic Microsomal Enzyme Induction and on the Kinetics of Steroid Oral Contraceptives in Healthy Female Volunteers

This study was conducted to determine whether vigabatrin affects in vivo indices of hepatic microsomal enzyme activity and the pharmacokinetics of steroid oral contraceptives in healthy subjects. Under double-blind conditions, 13 female healthy volunteers received, in random order and with a washout interval of > or = 4 weeks, two oral 4-week treatments with vigabatrin (VGB) (maintenance dosage, 3,000 mg daily) and placebo, respectively. The clearance and half-life of antipyrine (a broad marker of drug oxidation capacity), the urinary excretion of 6-beta-hydroxycortisol (a selective marker of cytochrome CYP3A-mediated oxidation), and the activity of serum gamma-glutamyltransferase (a nonspecific index of microsomal enzyme activity) were determined after 3 weeks of each treatment. The single-dose kinetics of a combined oral contraceptive containing 30 micrograms ethinyl estradiol and 150 micrograms levonorgestrel were also determined after 3 weeks of treatment by specific radioimmunologic assays. VGB treatment had no influence on antipyrine clearance (28 +/- 5.6 vs. 30 +/- 4.5 ml/h/kg on placebo), antipyrine half-life (15.5 +/- 3.5 vs. 14.1 +/- 2.1 h), urinary 6-beta-hydroxycortisol excretion (488 +/- 164 vs. 470 +/- 228 nmol/ day), 6-beta-hydroxycortisol-to-cortisol concentration ratio (6.8 +/- 3.1 vs. 6.1 +/- 3.1) and serum gamma-glutamyltransferase activity (12 +/- 3 vs. 11 +/- 3 IU/L). No difference in pharmacokinetic parameters between VGB and placebo sessions were found for ethinyl estradiol (half-life, 12.5 +/- 3.2 vs. 13.9 +/- 3.2 h; AUC, 874 +/- 301 vs. 939 +/- 272 ng/ L/h) and levonorgestrel (half-life, 17.7 +/- 5.2 vs. 23.1 +/- 9.8 h; AUC, 27.5 +/- 9.6 vs. 30.0 +/- 12.0 micrograms/L/h). Two subjects, however, showed a 50 and a 39% reduction in ethinyl estradiol AUC during VGB treatment. At therapeutic dosages, VGB did not modify in vivo indices of hepatic microsomal enzyme activity and did not interfere significantly with the CYP3A-mediated metabolism of ethinyl estradiol and levonorgestrel. Based on these data, VGB is unlikely to affect consistently the efficacy of steroid oral contraceptives or interact pharmacokinetically with drugs that are eliminated mainly by oxidative pathways, particularly those involving cytochrome CYP3A.

A reassessment of efficacy of the Yuzpe regimen of emergency contraception.

This review discusses the available data reporting the efficacy of emergency contraceptive treatment with the Yuzpe regimen (0.2 mg of ethinyl oestradiol in combination with either 2.0 mg of norgestrel or 1.0 mg of levonorgestrel) and evaluates the true effectiveness in preventing pregnancy. A literature review was completed for reports including women treated with the Yuzpe using a MEDLINE search for articles published since 1970 and by reviewing the secondary reference lists of these manuscripts. Expected pregnancy rates for each study population were calculated using published conception rate estimates. Seven published studies provided adequate data to assess accurately efficacy of the Yuzpe regimen in preventing pregnancy after unprotected intercourse. Of 2871 women treated, 54 (1.9%, 95% confidence intervals (CI) 1.4-2.4) became pregnant. By calculating the expected pregnancy rates using two different methodologies, the Yuzpe regimen decreased the observed number of pregnancies by 70.0% (95% CI 63.3-76.7) and 77.2% (95% CI 71.5-82.8). Emergency contraception with the Yuzpe regimen is an effective form of contraception to prevent unwanted pregnancy after unprotected intercourse.

Impact of combined hormone replacement therapy on serum lipid metabolism: New aspects

The objective of this study was to evaluate the impact of combined estrogen-progestogen therapy on low density lipoprotein (LDL) particle size (determined by the LDL cholesterol I apolipoprotein B ratio). The prospective study was carried out on 139 healthy Danish early postmenopausal women. The subjects were randomized to placebo or to 2 mg estradiol valerate equivalents, either sequentially combined with 75 μg levonorgestrel, 10 mg medroxyprogesterone acetate (MPA), or 150 μg deso-gestrel, or continuously combined with 1 mg cyproterone acetate. LDL particle size was calculated before treatment and at nine well-defined times during the subsequent 84 days.LDL particle size was reduced by all four treatments. This change was statistically significant for estradiol valerate combined with levonorgestrel and MPA (6.2 ± 2.7% and 5.6 ± 2.1% (mean ± SEM), respectively; p < 0.05for both, placebo-corrected). Estradiol valerate combined with MPA induced cyclic (progestogen-minus estrogen-related values) decreases (-6.3 ± 2.6%; p < 0.05), and with levonorgestrel there were cyclic increases (5.1 ± 2.7%; p = 0.067) in LDL particle size (placebo-corrected).In conclusion, combined estrogen-progestogen therapy causes a decrease in LDL particle size. A cyclic variation in LDL cholesterol/apolipoprotein B ratio was observed during sequential treatment.

Inhibition of ovulation by an oral contraceptive containing 100 μg levonorgestrel in combination with 20 μg ethinylestradiol

Twenty-four healthy female volunteers with normal ovulatory cycles, aged between 20 and 34 years (27.5 ± 4.3), were included in a single-center, non-comparative study to investigate the effect on inhibition of ovulation of an oral contraceptive containing 20 μg ethinylestradiol in combination with 100 μg levonorgestrel. At baseline, during three treatment cycles and post-treatment, ultrasonography was used to examine the ovaries, to measure follicular size, and to measure the thickness of the endometrium. Serum levels of LH, FSH, estradiol, progesterone, total tescosterone, free testosterone, SHBG, and CBG were also measured. Compared with treatment cycle 1, an increase in residual ovarian (follicle grades 4–5) was observed in cycles 2 and 3. Mean levels of LH, FSH, 17β-estradiol and progesterone remained suppressed during treatment. No escape ovulation was observed during the treatment phase of the study and there were no pregnancies. Ovulation was noted to return rapidly in the posttreatment cycle. Subjective and objective tolerance of the present regimen was noted to be good. Results indicate that the monophasic oral contraceptive containing 100 μ devonorgestrel combined with 20 μg ethinylestradiol effectively inhibits ovulation, providing adequate suppression of ovarian activity.

History and Efficacy of Emergency Contraception: Beyond Coca-Cola

Over 30 years of clinical use of emergency contraception has confirmed that such methods substantially reduce the chances of pregnancy, do not entail onerous service provision requirements, and are acceptable to women. The major obstacle to the more widespread use of postcoital methods is a lack of awareness on the part of both potential acceptors and service providers of this important option. Most extensively researched have been the Yuzpe method (200 mcg of ethinyl estradiol and 1.0 mg of levonorgestrel, taken within 72 hours of unprotected intercourse and then 12 hours later), levonorgestrel (two doses of 0.75 mg 12 hours apart starting within 48 hours of unprotected intercourse), and postcoital insertion of a copper IUD. Two new agents--RU-486 and the synthetic progestin and antigonadotropin danazol--offer promise, but require further evaluation. The Yuzpe method is estimated to reduce the likelihood of pregnancy by at least 75%. Lacking in the available literature are studies with rigorous research designs and methodologies capable of generating reliable data on efficacy and side effects, especially among women in developing countries. There is a need, for example, to limit samples to women who have had only one act of unprotected intercourse during a menstrual cycle and to those of proven fertility. Also important are studies that evaluate a range of distributional systems (e.g., vending machines) and user educational approaches. Finally, studies are needed to determine whether the Yuzpe method can be broadened to encompass all the progestins (e.g., desogestrel) used in combined oral contraceptives.

Hormonal treatment for bleeding irregularities in Norplant implant users

OBJECTIVE: Our purpose was to evaluate whether prolonged or irregular bleeding during Norplant implant use could be alleviated with the use of oral hormonal medication. STUDY DESIGN: One hundred fifty users of the Norplant levonorgestrel contraceptive implant with prolonged or frequent bleeding were enrolled in this prospective, randomized, comparative study and assigned to one of three treatment groups for 20 days: ethinyl estradiol 50 μg, an oral contraceptive (50 μg ethinyl estradiol and 250 μg levonorgestrel), and placebo. Total days of bleeding during treatment and length of the bleeding-free interval were analyzed. RESULTS: Women treated with the levonorgestrel - ethinyl estradiol pill bled an average of 2.6 days during treatment compared with 5.4 and 12.3 days in the ethinyl estradiol and placebo groups, respectively. Differences between both hormonal groups and placebo were significant ( p < 0.00001); moreover, the combined pill was more effective than ethinyl estradiol alone ( p < 0.0001). CONCLUSION: The combined pill proved to be an excellent palliative treatment and is a more practical approach because of availability at all clinic sites. (A M J O BSTET G YNECOL 1996;174:919-22.)

Comparative study on intermittent versus continuous use of a contraceptive pill administered by vaginal route

A multicenter, international, randomized, comparative trial was conducted to assess the acceptability, efficacy and safety of two different schedules of a contraceptive pill, containing 250 μg levonorgestrel and 50 μg ethinyl estradiol, administered by the vaginal route. One schedule of daily administration for 21 days with a seven-day interruption to allow withdrawal bleeding was compared to daily administration without interruption for bleeding. A total of 900 women were recruited in three countries, Brazil, Egypt and China; 7,090 women-months of vaginal pill use were recorded (3,364 using the pills intermittently and 3,726 continuously). Four undesired pregnancies occurred, one in Egypt and three in China, all four in women using the pills intermittently. There was a statistically significant difference (p = 0.486) in pregnancy rate between the two groups. There were no other significant differences in discontinuation rates despite marked differences in bleeding patterns, amenorrhea predominating in the continuous use group. Hemoglobin levels increased significantly in the two groups but hematocrit was significantly higher in the continuous use group.

Is time-interval between mini-pill ingestion and breastfeeding essential?

A study was conducted on four alternate days over an eight-day period in a group of 12 healthy, 20–35 year old exclusively breast feeding women who were interested in weaning their infants. On each study day the women ingested 150 μg levonorgestrel. Maternal blood and milk samples were collected at 2, 4, 6, and 8 hr intervals after LNG ingestion on the 1st, 3rd, 5th, and 8th day. A time-dependent decrease in maternal serum and increase in breast milk levels of LNG were observed. Maintaining a time interval between mini-pill intake and breastfeeding results in higher levels of LNG in breast milk, thereby exposing the infant to a bolus of LNG in a “single-delayed” feed.

Transdermal estrogen with a levonorgestrel-releasing intrauterine device for climacteric complaints: Clinical and endometrial responses

OBJECTIVE: Our purpose was to study the effects of intrauterine release of a daily dose of 20 μg levonorgestrel by an intrauterine device on climacteric symptoma, bleeding pattern, and endometrial histologic features in postmenopausal women receiving transdermal estrogen replacement therapy. STUDY DESIGN: Forty parous postmenopausal women were randomly allocated into two groups for 1 year: 20 women receiving a continuous transdermal daily dose of 50 μg of estradiol had a levonorgestrel-releasing intrauterine contraceptive device inserted, and the control group of 20 women received a continuous oral dose of 2 mg of estradiol valerate and 1 mg of norethisterone acetate daily. The climacteric symptoms, bleeding patterns, endometrial thickness, and endometrial changes in biopsy samples were analyzed. Serum levels of estradiol in both groups and levonorgestrel levels in the intrauterine device group were also determined. RESULTS: Both treatment regimens effectively relieved climacteric symptoms. Spotting was more common in the intrauterine contraceptive device group than in the oral therapy group for the first 3 months. After that, the proportion of women without any bleeding was similar in both groups. Two patients in each group dropped out because of bleeding. CONCLUSION: These preliminary findings suggest that the levonorgestrel-releasing intrauterine contraceptive device is a useful alternative mode of progestin administration for certain selected women receiving estrogen replacement therapy.

Contraceptive Implant Found Safe, Acceptable, Among Chinese Women

According to a 5-year multicenter study the hormonal contraceptive implant is highly effective and acceptable among Chinese women. In this study a total of 10718 women at 12 health centers and nearby subcenters throughout China were enrolled. These women were aged 30.2 years on average weighed 54.5 kg at enrollment and had at least one living child. The implants which consisted of six capsules containing a total of 216 mg of levonorgestrel were inserted at outpatient clinics at teaching hospitals medical colleges and research institutes in large urban centers. Overall a very low rate of insertion complications (4.7/10000 woman-years) attributed to careful training and supervision was found. In addition it was noted that 72% of the initial participants used the implant continuously for 5 years. The primary reason for removal or discontinuation was menstrual disturbance. Moreover the cumulative 5-year pregnancy rate was 1.5 pregnancies per 100 woman-years indicating that rates declined with age and rose with body weight.