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Postponement of withdrawal bleeding with a monophasic oral contraceptive containing desogestrel and ethinylestradiol.

This study investigated the ability of a monophasic sub-50 oral contraceptive, containing desogestrel and ethinylestradiol, to postpone withdrawal bleeding in normal healthy women. In the analyzed group of 105 regular users of Marvelon, about 75% did not experience any vaginal bleeding during the 21 days of postponement. A 95% confidence interval was calculated which suggests that the percentage of women able to postpone their withdrawal bleeding successfully for 19 days ranges between 67.0% and 83.5%. Women with no vaginal blood loss in the postponement period were more willing to try this method of postponement again, compared to women who experienced vaginal blood loss in the postponement period. This difference was statistically significant. Nevertheless, the majority of women with vaginal blood loss were also willing to try this method again if necessary. The study results suggest that Marvelon offers an effective and acceptable method of postponing withdrawal bleeding for three weeks for most regular users of this contraceptive.

Adolescent↗

Effects of low and high dose oral contraceptives on blood coagulation and thrombogenesis induced by vascular subendothelium exposed to flowing human blood.

We investigated the effect of oral contraceptives with low and high estrogen concentration on blood coagulation and thrombogenesis, induced by vascular subendothelium of rabbit aorta exposed to flowing human blood. Twenty healthy women intending to take oral contraceptives were studied [1] before drug ingestion (control), and subsequently during the intake of oral contraceptives with [2] low estrogen content (20 micrograms ethinyl estradiol and 150 micrograms desogestrel per day) and [3] high estrogen content (50 micrograms ethinyl estradiol and 125 micrograms desogestrel per day). All experiments were performed between day 17 and 21 of the menstrual cycle and drug effects were studied during the third tablet cycle. Deposition of fibrin, platelets and platelet thrombi on vascular subendothelium was tested at a defined blood flow and wall shear rate (10 ml/min, 650 s-1) and was quantified by morphometrical techniques. Treatment with the low and high dose contraceptive increased the plasma levels of ethinyl estradiol (728 +/- 139 and 1438 +/- 212 vs. 0 fmol/l [low and high dose vs. control], means +/- SEM, P less than 0.001) and fibrinogen (2.3 +/- 0.1 and 2.6 +/- 0.1 vs. 2.0 +/- 0.1 g/l, P less than 0.05); and decreased antithrombin III activity (95 +/- 3 and 92 +/- 3 vs. 101 +/- 3 %, P less than 0.05). Fibrin deposition on vascular subendothelium was enhanced by the high dose contraceptive only (47 +/- 4 vs. 35 +/- 4 % coverage of the subendothelial surface with fibrin, high dose vs. control, P less than 0.05). The subendothelial deposition of platelets and platelet thrombi was not changed by contraceptive treatment. These results indicate that treatment with high dose contraceptives leads to an increase of fibrin-subendothelial interactions, whereas low dose contraceptives do not significantly alter the blood-subendothelium interactions. observed in this ex vivo model of thrombogenesis.

Adolescent↗

A double-blind comparison of the efficacy and acceptability of Femodene and Microgynon-30.

The efficacy, cycle-control and tolerance of Microgynon-30, a widely prescribed levonorgestrel containing oral contraceptive, and Femodene, a new oral-contraceptive containing gestodene, were compared in a randomised, double-blind study involving 456 healthy women over a 6 month period. 229 women were allocated to receive Femodene and 227 received Microgynon-30. No differences between the groups in terms of obstetric and gynaecological history, previous contraceptive history, smoking habits, blood-pressure or body weight at admission were observed. No pregnancies were reported in either group, despite tablet-taking errors recorded in 6.3% of the Femodene group and 7.6% of the Microgynon-30 group. Both oral contraceptives were compared in terms of cycle length, intensity of the withdrawal bleed and side effects. Cycle-control was similar in the two groups. However, significantly fewer subjects reported breakthrough bleeding (with or without spotting) in the Femodene group (18% of patients) compared with the Microgynon-30 group (26% of patients). The incidence of absent withdrawal bleeds was 1% or less in both groups and no significant effects on body weight or blood pressure were observed.

Adolescent↗

Side effects and compliance with low- and conventional-dose oral contraceptives among adolescents.

Oral contraceptives are the most popular birth control method for teenagers, yet many teens discontinue use of these contraceptives prematurely. The need to minimize any potential long-term medical complications from the use of contraceptive hormones must be balanced with the desirability of increasing acceptance of contraceptives by adolescents. There has been concern that the use of so-called "low-dose" estrogen preparations, although decreasing the likelihood of complications, may lead to side effects that make compliance less certain. The present study comparing two commonly used oral contraceptive preparations, one low dose, one conventional dose, tests the hypothesis that among adolescents an association exists between oral contraceptive side effects and compliance. Using a double-blind crossover method, 55 sexually active adolescent females received two months each of a preparation containing 35 micrograms ethinyl estradiol and 0.5 mg norethindrone and another containing 50 micrograms mestranol and 1.0 mg norethindrone. The 50-microgram preparation was associated with fewer side effects when administered during the first two months. No differences in side effects were noted in the latter two months, but there was a slight increase in weight gain when compared with the 35-microgram preparation. The most common side effect was inter-menstrual bleeding with the 35-microgram pill. There was no documented relationship between the occurrence of side effects and compliance.

Adolescent↗

Comparison of the action of nonoxynol-9 and chlorhexidine on sperm.

The effect on sperm motility of nonoxynol-9 chlorhexidine diacetate was compared in semen and cervical mucus. Both compounds had similar spermicidal potency in semen, abolishing sperm motility within 3 minutes at 0.5 mg/ml. When these compounds were allowed to diffuse into mucus, the subsequent survival of sperm in the mucus was different. Restricted penetration and loss of motility occurred rapidly after treatment with 0.1 mg/ml chlorhexidine, whereas sperm survived normally in mucus after prolonged contact with 200 mg/ml chlorhexidine. When the compounds were mixed directly with the mucus before sperm penetration was attempted, chlorhexidine still immobilized sperm, but concentrations of nonoxynol-9 that would be spermicidal in semen had no effect in mucus.

Animals↗

Oral contraceptive use and premenopausal breast cancer in Sweden and Norway: possible effects of different pattern of use.

Different use of oral contraceptives (OCs) in relation to reproductive histories and age might explain the conflicting results found in studies from different countries of OC use and premenopausal breast cancer. A population-based case-control study in Sweden and Norway has been analysed separately for the two countries. The study consists of 317 Swedish and 105 Norwegian cases diagnosed 1984-1985 with 317 Swedish and 210 Norwegian controls. The results for each country separately are consistent with the joint analysis showing increased risk for breast cancer with increased duration of OC use with the exception of that for women with more than 15 years since first use. The relative risk of breast cancer for more than four years of use among Norwegian women was 0.6 (95% confidence internal (Cl), 0.2-1.8). In both countries there was a non-significant higher risk associated with increasing duration of use before first full-term pregnancy. Analyses for surveillance bias show no evidence of bias as explanation for the association between total duration of OC use and breast cancer.

Adult↗

Cycle control with triphasic norgestimate and ethinyl estradiol, a new oral contraceptive agent.

Effective cycle control was demonstrated based on two multicenter, 2-year studies of the triphasic oral contraceptive (OC) agent containing the new progestin norgestimate. The estrogen in this OC is ethinyl estradiol. These open-label Phase III studies were conducted in the United States by 33 investigators at 33 sites who treated a total of 1,783 subjects, healthy women 17 to 38 years of age with menstrual cycle characteristics considered to be within the normal range. The norgestimate/ethinyl estradiol preparation was taken for up to 24 cycles. Follow-up information was collected 3 to 4 months post-treatment. Bleeding pattern analyses were based on 27,970 valid cycles. Normal cyclic bleeding patterns were experienced by most of the women during the study; only minimal and statistically and clinically insignificant variations in menstrual flow, dysmenorrhea, and premenstrual tension occurred. There was a low incidence of failed withdrawal bleeding in single cycles (less than 1.0% after cycle 6). There were no cases of amenorrhea, defined as two consecutive cycles of missed withdrawal flow. The incidence of breakthrough bleeding or spotting was highest during the initial treatment cycles and diminished with continued use of the formulation. The mean incidence of breakthrough bleeding was 2.36% in cycles 13 to 24. Apart from somewhat higher initial percentages among women new to oral contraception, the pattern of midcycle bleeding or spotting was similar to that of all women studied. Effective long-term cycle control was demonstrated in women who used this OC agent.

Adolescent↗

The relationship between menarche and sexual, contraceptive, and reproductive life events.

Relationships between menarche and sexual, contraceptive, and reproductive life events were investigated by structured interviews of 585 Danish women, aged 15-54 years. Data were analyzed by multivariate test statistics. The trend toward an earlier menarche was confirmed. No association was found between menarche and social class. Women with early menarche had an earlier coital debut. After correction for coital debut, no association was observed between menarche and coital frequency, number of sexual partners, or use of oral contraceptives. Menarche was not associated with number of births, spontaneous or induced abortions, or frequency of ectopic pregnancies. The results suggest that the predictive value of the menarche for sexual and contraceptive life events is conditioned primarily by the association between menarche and coital debut.

Abortion, Induced↗

Multicentre study with a new biphasic oral contraceptive containing ethinylestradiol and desogestrel. Report on efficacy, cycle control and adverse experiences with special emphasis on blood pressure and weight.

In a multicentre study 882 women were treated during a total of 12850 cycles with a new biphasic oral contraceptive: CTR 24. The study period was 18 cycles. The biphasic preparation CTR 24 contains 25 micrograms desogestrel (CAS 54024-22-5) plus 40 micrograms ethinylestradiol (CAS 57-63-6) daily for the first 7 days followed by the combination of 125 micrograms desogestrel and 30 micrograms ethinylestradiol daily for the subsequent 15 days. One pregnancy occurred. The woman had forgotten one tablet on Day 6 of Cycle 12. The Pearl Index was 0.1 (0.0-0.5) for patient failure. The combination had a good cycle control and only few side effects were reported.

Blood Pressure↗