Comparative acceptability of combined and progestin-only injectable contraceptives in Kenya. A multicentre phase III comparative study of two hormonal contraceptive preparations NET-OEN (50 mg) + E2 valerate (5 mg) given every month and NET-OEN (200 mg) given every 2 months as intramuscular injection--a report of 12-month study. Indian Council of Medical Research Task Force on Hormonal Contraception. Low-dose oral contraceptive to re-induce menstrual bleeding in amenorrheic women on DMPA treatment: a randomized clinical trial. Acceptability of injectable contraceptives in Assiut, Egypt. A randomized, double-blind study of two combined and two progestogen-only oral contraceptives. Once-a-month injectable contraceptives, Cyclofem and Mesigyna, in Egypt. Efficacy, causes of discontinuation, and side effects. Continuous combination oral contraceptive pills to eliminate withdrawal bleeding: a randomized trial. Comparative study on intermittent versus continuous use of a contraceptive pill administered by vaginal route. A randomized, double-blind study of six combined oral contraceptives.
We compared 12-month continuation rates, menstrual bleeding patterns and other aspects of acceptability between users of Cyclofem and users of Depo-Provera.
                The life-table method was used to calculate quarterly continuation rates. In all, 360 Kenyan women were randomly assigned to one of the two contraceptives. User-satisfaction questionnaires were administered at 6 and 12 months or at discontinuation, whichever occurred first.
                The 1-year continuation rate was 75.4% for Depo-Provera users versus 56.5% for Cyclofem users (p<.001). Main reasons for discontinuation included difficulty making clinic visits (45.1% for Cyclofem vs. 40% for Depo-Provera), menstrual changes (14.1% vs. 12.5%) and nonmenstrual problems (15.5% vs. 12.5%). None of the Depo-Provera users and 8.5% of the Cyclofem users claimed frequency of visits as the main reason for discontinuation. In all, 70.6% of the Depo-Provera users were amenorrheic after 12 months, as were 20.8% of the Cyclofem users.
                The 1-year continuation rate was higher for Depo-Provera than for Cyclofem. There was no important difference in discontinuation rates because of menstrual problems; the difference mainly reflected the frequency of visits required. A phase III randomized clinical trial was undertaken to compare the efficacy, side effects and acceptability of a combined monthly injectable preparation containing NET-oenanthate (NET-OEN) (50 mg) plus oestradiol valerate (E2 Val.) (5 mg) with NET-OEN only (200 mg) given every two months. A total of 849 subjects were observed for 7817 woman-months of contraceptive use. Net discontinuation rates due to involuntary pregnancy at 12 months were 0.2 and 1.1 per 100 users for one monthly and two monthly injectable preparations, respectively. Although the monthly preparation was found to be efficacious and the subjects using the monthly preparation had a better bleeding pattern, the net discontinuation rate at 12 months due to menstrual disturbances did not show any significant difference between the two preparations. With proper counselling and motivational strategies, it is likely that acceptability of monthly injectables can be further enhanced. Depot medroxy progesterone acetate (DMPA) is one of the most reliable contraceptive methods with a failure rate less than 0.3 percent. It is injected every three months and Although it has many advantages over many other hormonal contraceptives, But a major disadvantage of it is bleeding disorders which comprise most of the discontinuance reasons. Our Aim was to study bleeding complications of DMPA when used as a contraceptive in Ardabil district and clinical trial of LD and Ethynil oestradiol in controlling these complications.
                All the 917 women who referred to ardabil's health centers for having a DMPA injection for the first time, were entered into a longitudinal study. Those complaining of menstrual cessation were entered into a double blinded randomized clinical trial. Data were collected by means of 9 questionnaires 7 of them used for descriptive and 2 for clinical trial study. Data was analyzed by SPSS statistical package.
                Those DMPA users with a cesarean section history had a higher chance of bleeding complications. Four hundred forty-four of the 917 women receiving the injection discontinued using it before the end of the study period. The main reason for discontinuation (in 70%) was irregular menstrual bleedings and menstrual cessation. In the clinical trial of women with bleeding cessation, 70% of those receiving the LD-OC pill experienced menstrual bleedings again, compared with only 22.7% in the placebo group. The discontinuation rate in the drug group was lower than in the placebo group as well (p < 0.05).
                Treating menstrual cessation caused by DMPA with LDs, improves the complication and decreases the discontinuance rate. The present work was a randomized comparative study of two injectable progestogen-only contraceptives. The first group (200 subjects) received 150 mg of depotmedroxyprogesterone acetate (Depoprovera) every 84 +/- 7 days and the second (200 subjects) received 200 mg of norethisterone enanthate (Noristerat) every 56 +/- 7 days. Acceptors of injectable contraceptives in Assiut, Egypt, were mainly women looking for fertility termination. Menstrual disruption was the main side effect among both treatment groups. Amenorrhoea was the commonest menstrual complaint and was the main reason for discontinuation in both groups. Only one pregnancy occurred during NET-EN use; two more pregnancies occurred, one in each of the two groups but there were indications that conception preceded the first injection. Menstrual irregularities were generally more frequent with DMPA users. However, DMPA had better one-year continuation rates than NET-EN (68.8 +/- 3.5 and 57.1 +/- 3.6 per 100 women, respectively). A randomized double-blind study of two combined oral contraceptives and two progestogen-only oral contraceptives was conducted using the same protocol at WHO Collaborating Centres for Clinical Research in Human Reproduction in Bombay and Ljubljana of the 518 women admitted to the trial, 123 received mestranol 50 micrograms + norethisterone 1mg (MES 50 + NET 1); 137 received ethinyl estradiol 30 micrograms + levonorgestrel 150 micrograms (EE 30 + LNG 150); 130 received norethisterone 350 micrograms/NET 350); and 128 received levonorgestrel 30 micrograms (LNG 30). At one year, between 52.6 and 61.0 percent of those recruited had discontinued oral contraceptive use for all reasons, and by two years, between 70.5 and 76.5 percent had discontinued the treatment. These rates did not differ between the four treatment groups. However, discontinuation rates for all medical reasons at one and two years, and at two years pregnancy rates and discontinuation rates for bleeding disturbances, were significantly lower in the EE/LNG preparation. The groups receiving the MES/NET, LNG and NET had similar pregnancy rates, discontinuation rates for all medical reasons and all bleeding disturbances. There were two ectopic pregnancies among the 22 pregnancies in the progestogen-only groups. Discontinuation because of headache, dizziness and other central nervous system symptoms were significantly more common in those receiving MES/NET compared to EE/LNG. In contrast, discontinuation for gastro-intestinal disturbances were significantly higher in the EE/LNG combined preparation. Bleeding disturbances in the first few cycles tended to be higher in NET than in the LNG group. The data suggest that greater consideration be given to the benefits and risks of including progestogen-only oral contraceptives in the family planning programmes of some countries. A clinical trial of the two once-a-month injectable contraceptives, Cyclofem and Mesigyna, used for 1 year was carried out in Egypt involving a total of 2252 women living in different Egyptian localities, representing urban/rural and Upper/Lower Egyptian populations. Women were randomly assigned to either one of the two study preparations and followed a standard protocol for a comparative assessment of the efficacy, side effects, and acceptability of the two preparations. Both contraceptives proved to be highly acceptable, with continuation rates of 63.2 per 100 women-years for Cyclofem and 61.6 for Mesigyna at the end of 12 months of use. The cumulative discontinuation rates per 100 women-years for method failure were 0.19 for Cyclofem users and 0.41 for Mesigyna users. Menstrual problems were the most frequently reported side effects in both groups. Discontinuation rates because of amenorrhea were 2.74 in the Cyclofem group compared to 1.38 in the Mesigyna group, whereas the rates of discontinuation because bleeding problems were significantly higher among Mesigyna users (11.54) compared to the Cyclofem group (7.39). There was no significant difference between the two groups regarding the discontinuation rates from other medical and personal causes. There were insignificant changes in the systolic and diastolic blood pressure values recorded at follow-up; only one Cyclofem user developed systemic hypertension (160/100 mm Hg) after 6 months of use and was discontinued for that reason. On the other hand, a constant weight gain averaging 0.33 kg/month was observed in both groups; however, weight gain was not considered a major cause of method discontinuation. To compare bleeding profiles of a traditional 28-day oral contraceptive pill cycle with continuous administration.
                After a 28-day run-in cycle, women were randomized to either 28-day cycles (21 active pills and a pill-free week) or continuous use of the same 20 microg ethinyl estradiol/100 microg levonorgestrel formulation for 12 study cycles (336 days). The number of bleeding and spotting days were measured by daily diary. A subset underwent cycle 1 (n = 16), and nine (n = 14) pelvic ultrasound and endometrial histology sampling. Blood pressure, weight, hemoglobin, and adverse events were measured at revisit. The sample size with 80% power to detect a 67% reduction in bleeding days required 27 subjects in each arm.
                Of the 79 subjects randomized, 28 (70%) of the 28-day cycle and 32 (82%) of the continuous-use subjects completed the entire study (P =.6). With continuous use, 49%, 68%, and 88% of women reported no bleeding during cycles 2, 6, and 12, respectively. Amenorrhea or infrequent bleeding was present in 68% of continuous users during cycles 1-3 and increased to 88% during cycles 10-12. Spotting during cycle days 1-21 increased initially with continuous use but reduced over time, and by 9 months was less than the spotting reported by cyclic users. Adverse events, blood pressure, weight, and hemoglobin findings were similar between groups.
                Extension of the 28-day oral contraceptive cycle to continuous use with a low-estrogen dose combination oral birth control pill resulted in significantly fewer bleeding days. 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 micrograms levonorgestrel and 50 micrograms 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. A randomized controlled clinical trial comparing six combined oral contraceptives with 50 micrograms or less of ethinyl estradiol was undertaken in 10 WHO Collaborating Centres for Clinical Research in Human Reproduction. A total of 2430 women entered the trial and were observed for 28,077 woman-cycles. All low-dose combined oral contraceptives demonstrated equivalent efficiency with one-year pregnancy rates of one to six percent. However, discontinuation rates for medical reasons differed significantly between the treatment groups, with the preparation containing 20 micrograms ethinyl estradiol and that containing 400 micrograms norethisterone acetate being associated with higher discontinuation rates due to bleeding disturbances. Even among the preparations which did not differ in discontinuation rates, the reasons for discontinuation did differ. Women receiving norethisterone preparations tended to discontinue because of bleeding disturbances while those receiving the levonorgestrel-containing preparations tended to discontinue because of complaints of nausea and vomiting.
While discontinuation rates can be viewed as a measure of method acceptability, the findings should be interpreted with caution since discontinuation depends on many factors. Future research should be directed toward improving the acceptability of combination injectable contraceptives, such as providing injections in settings more convenient than clinics, methods for women to administer their own injections, and counseling about possible bleeding pattern changes.