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The androgenicity of oral contraceptives: the young patient's concerns.

Sexual activity is quite common among women aged 14 to 20 in developed countries, averaging perhaps 10% at age 15 to about 70% at 19. Thus, the need for contraception may begin quite early in life and will continue for as long as 30 years. One of the best candidates for long-term contraception for young sexually active females is the oral contraceptive (OC), which provides health benefits besides contraception. Long-term benefits include lowered rates of ovarian and endometrial cancer, as well as of benign breast disease and ovarian cysts. Another benefit is protection against upper-tract sequelae of sexually transmitted diseases. Short-term benefits are correction of menstrual irregularity, reduction in menstrual flow, and diminished premenstrual syndrome and dysmenorrhea. Recent OC formulations contain only one-third the estrogenic potency of older OCs and therefore are associated with dramatic decreases in what were always the major side effects of OCs: heart attack, stroke, and pulmonary embolism. Other side effects of OCs have been most closely associated with the progestogenic component, and are related to the androgenic effects of progestins, particularly some synthetic progestins. However, some new synthetic progestins have been found to have minimal androgen receptor activity in preclinical testing and to cause minimal or no androgen-related side effects in clinical trials. One of these new progestins having a favorable androgenic profile is norgestimate. Its efficacy and safety in combination with low doses of ethinyl estradiol have been documented in the European and the American literature.(ABSTRACT TRUNCATED AT 250 WORDS)

Acne Vulgaris↗

Clinical and endocrine effects of long-term hormonal contraception.

Clinical effectiveness and side effects of a biphasic oral hormonal contraceptive preparation (levonorgestrel /LNG/ 10 X 0.05 mg+ + 11 X 0.125 mg, ethinyl oestradiol /EO/ 21 X 0.05 mg) were compared with the effect of a classical high fixed dose combination pill (LNG 21 X 0.25 mg, EO 21 X 0.05 mg). The biphasic pill was used by 121 women during 1844 cycles, while the fixed dose pill was used by 142 women during 1940 cycles. In the comparison with the life table method, termination of pill use for medical reasons and loss to follow up proved to be significantly different in favour of the biphasic pill.

Contraceptives, Oral, Hormonal↗

Contraception and pregnancy among young women in an urban Swedish population.

The reproductive history and use of contraception in a representative sample of 19-year-old women from the city of Göteborg is reported. Oral contraceptives (OC) were taken by 47%, 4% had an intrauterine device and 12% used a barrier method while 37% practiced no form of contraception. The type of OC used and reasons for discontinuation are presented. The duration of OC use was one year or less for 46% of the women and exceeded 3 years in only 10%. Major causes of discontinued OC were the result of side effects attributed by the woman to OC, or a fear of OC. There were 93 pregnancies reported in the population sample, resulting in the birth of 34 infants. Pregnancy was terminated by legal abortion in 51% of the reported pregnancies. The ready availability of a return visit to discuss possible side effects and fears resulting from the chosen method of contraception may improve continuity, thus reducing the number of legal abortions.

Abortion, Legal↗

Clinical acceptability, use-patterns and use-effectiveness of the vaginal contraceptive sponge and Neo Sampoon tablets--an international multi-center randomized clinical trial.

This paper describes the results from a randomized clinical trial comparing the Collatex vaginal contraceptive sponge (a predecessor of the Today sponge) and Neo Sampoon foaming vaginal contraceptive tablets; the trial was conducted from 1979 to 1983 in four centers located in three countries (two in Yugoslavia and one each in Taiwan and Bangladesh). The sponge was associated with more insertion and retention problems than the tablet, especially in the two Asian centers. More Neo Sampoon users complained of a burning or stinging sensation. This complaint, however, seemed to be well-tolerated and was not a frequent reason for irregular use and/or discontinuation of use of the tablets. Clinically significant medical complications were rarely reported for either method. Sponge users were more likely to report irregular use than tablet users, primarily due to inconvenience of use. Rates of discontinuation at six months of use were also consistently higher among sponge users than Neo Sampoon users in the four centers. Life-table pregnancy rates at 12 months of use ranged from 3.8 to 18.2 per 100 sponge users and 6.2 to 29.9 per 100 Neo Sampoon users, based on data from the two Yugoslavian centers and the Taiwan center (data from the Bangladesh center were excluded from analysis of pregnancy rates). Practical implications of these findings are discussed.

Adolescent↗

Post-coital contraception: an overview of published studies.

Information from published studies testing the effect of hormonal and mechanical interceptive methods in post-coital contraception was pooled with the aim of assessing the efficacy of various regimens. The pooled failure rates were 0.6% (19/3168 based on four studies) for high-dosage ethinylestradiol, 1.1% (11/975, based on two studies) for other high-dose estrogens, 1.8% (69/3802 based on 11 studies) for combined estro-progestin preparations, 2.0% (20/998 based on three studies) for danazol and 0.1% (1/879 based on nine studies) for intra-uterine devices (IUD). Although this overview has several limitations in terms of over-representation of optimistic results in the literature or absence of direct comparison between treatments in several studies, it suggests that IUD and high-dose ethinylestradiol are more efficacious forms of post-coital contraception than danazol or combined contraceptives.

Contraceptives, Postcoital↗

Oral contraceptives and neoplasia of the ovary.

Epidemiologic literature on oral contraceptives in relation to primary ovarian cancer is reviewed. Compared to women who have never used oral contraceptives, women who have ever taken oral contraceptives have about a 30% reduction in risk for epithelial ovarian cancer, and five or more years of use is associated with a 50% reduction in risk. The protective effect of oral contraceptives persists for ten or more years after use is discontinued, and becomes apparent several years after beginning use. Effects of oral contraceptives are similar for malignant and borderline malignant epithelial ovarian cancer. Reduced risks among oral contraceptive users have been observed for all major histologic subtypes of epithelial ovarian cancer, and for women from developed and developing countries. Risk estimates for epithelial ovarian cancer in relation to oral contraceptive use stratified by age at diagnosis or parity are not uniform across studies. No consistent protective effect is apparent for non-epithelial ovarian tumors or benign ovarian tumors, including teratomas and cystadenomas, although limited data are available on the relationship between oral contraceptives and these neoplasms. Several areas for future research are described.

Contraceptives, Oral↗

Use and misuse of oral contraceptives: risk indicators for poor pill taking and discontinuation.

The contraceptive efficacy of oral contraceptives (OCs) depends on their proper and continued use, particularly with lower estrogen preparations. However, few studies have examined why women miss pills or discontinue OCs, and those that do tend to be small and to focus on adolescents. To address the issues of poor OC compliance and early OC discontinuation, we analyzed OC use in a convenience sample of 6,676 women between the ages of 16 and 30 from Denmark, France, Italy, Portugal, and the United Kingdom. Logistic regression was used to examine the independent effect of each factor. Poor compliance was associated with a lack of established routine for pill-taking (relative risk [RR] = 3.3), failure to read and understand written materials that came with the OC package (RR = 2.2), not receiving adequate information or help about OCs from their health care provider (RR = 1.5), and occurrence of certain side effects, including hirsutism (RR = 2.1), nausea (RR = 1.4), bleeding irregularities (RR = 1.3), and breast tenderness (RR = 1.2). Women who were inconsistent OC users, missing one or more pills per cycle, were almost three times as likely to experience an unintended pregnancy while using OCs than were women who took their OCs consistently. Factors that predicted early discontinuation (women who wished to continue contraceptive protection but discontinued OC use) were primarily side effects, including nausea (RR = 2.1), bleeding (RR = 1.9), breast tenderness (RR = 1.8), mood changes (RR = 1.8), and weight gain (RR = 1.4).(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

Menstrual regulation and contraception in Bangladesh: competing or complementary?

To examine the relationship between menstrual regulation (MR) and subsequent use of contraception in Bangladesh, we studied the birth control practices of a 6-month cohort of 4359 family-planning acceptors in a family-planning clinic in Dacca. We compared their use of birth control measures before and after MR. We attempted to examine the subsequent pregnancy and induced-abortion rates of 1671 of these women through a 3-year non-concurrent prospective study. Of those 1172 made their first visit to the clinic to obtain an MR and the remaining 499 women, who served as a comparison group, made their first visit to obtain contraceptive services not associated with MR. Three years' followup data were available for 558 women in the MR group and 228 women in the comparison group. Based on these data, the 3-year pregnancy rate for the MR group was 37.6/100 women and the induced abortion rate was 4.3/100 women. The 3-year pregnancy rate for the comparison group was 39/100 women and the induced abortion rate was 3.5/100 pregnancies. Thus, during a 3-year period women in the MR group did not obtain abortions significantly more often than women in the comparison group.

Abortion, Induced↗

Breast cancer detection in relation to oral contraception.

Analyses of tumor size and breast cancer stage were used to determine whether biased detection of breast cancer could have materially influenced estimates of risk associated with use of oral contraceptives. In a population-based case-control study conducted from 1980-1982, surveillance for breast cancer by breast exams, but not mammography, was found to be strongly linked to use of oral contraceptives. Tumors were slightly smaller and less likely to be late-stage (TNM stage III or IV) in patients who had used oral contraceptives. The net effect of any diagnostic bias on advancing the date of cancer diagnosis, whether from breast exams or other sources, was estimated to be less than 8 weeks. This corresponds to spuriously increasing the risk of early-occurring breast cancer in oral contraceptive users by at most 2.4% (relative risk = 1.024).

Adult↗

Contraception and sexually transmitted diseases: interactions and opportunities.

Today "safe sex" means protection from both unintended pregnancy and sexually transmitted disease and human immunodeficiency virus. These parallel complications of sexual activity have serious biologic and clinical sequelae that should be considered at the time of contraceptive selection. In addition, there is ongoing debate regarding potential interactions between antibiotic intervention and contraceptive steroids. This article assesses the impact of hormonal contraception, spermicides, barrier methods, intrauterine devices, and douching on the pathogenesis of sexually transmitted disease and the human immunodeficiency virus infection. It discusses the direct and indirect effects of contraception methods on clinical physiology and host immune responses while also considering the possible consequences on maternal and infant health if pregnancy results from the use of ineffective contraception. Counseling and care for both family planning and infectious disease protection must be provided to all sexually active individuals.

Contraception↗

A twelve-month comparative clinical investigation of two low-dose oral contraceptives containing 20 micrograms ethinylestradiol/75 micrograms gestodene and 30 micrograms ethinylestradiol/75 micrograms gestodene, with respect to efficacy, cycle control, and tolerance.

The aim of this study was to compare contraceptive reliability, cycle control, and tolerance of an oral contraceptive containing 20 micrograms ethinylestradiol (EE2) and 75 micrograms gestodene (GSD), with a reference preparation containing a similar dose of gestodene but in combination with 30 micrograms ethinylestradiol. A higher incidence of intermenstrual bleeding was apparent under the 20 micrograms EE2 oral contraceptive. For the 20 micrograms EE2 preparation, 47.4% of all women reported spotting at least once over a period of 12 treatment cycles, whereas this figure was 35.5% for the 30 micrograms EE2 pill (p < 0.05). However, the incidence was within a range that corresponds to that of other OCs. The cumulative breakthrough bleeding rates (at least once during the one year of treatment) of 14.5% (20 micrograms EE2) and 11.8% (30 micrograms EE2) of women were not significantly different. In relation to all cycles, the intermenstrual bleeding rates were remarkably lower, indicating that the majority of the volunteers experienced such events only in few cycles under treatment: the spotting rate was 11.5% (20 micrograms EE2) and 7.2% (30 micrograms EE2) of all cycles, and the breakthrough bleeding rate was 2.6% and 1.6% of all cycles, respectively. Three pregnancies were recorded during the study (one in the 20 micrograms EE2 + 75 micrograms GSD group, two in the 30 micrograms EE2 + 75 micrograms GSD group). All three could be explained either by intake irregularities or by circumstances impairing the contraceptive effect. The influence of both treatments on the blood pressure and body weight proved to be extremely slight. Adverse events in both groups were rare and differences in the frequency of adverse events were not apparent. The discontinuation rate due to adverse events, including intermenstrual bleeding, was low (9.8% for 20 micrograms EE2 + 75 micrograms GSD, and 7.2% for 30 micrograms EE2 + 75 micrograms GSD) and was in the lower range known for other oral contraceptives. Both preparations were well accepted by the volunteers. The data obtained demonstrate clinically acceptable cycle control, good tolerance, and a high standard of contraceptive reliability for both drugs. Prescription of the 20 micrograms EE2 preparation could be the first-line therapy in order to provide the lowest amount of EE2 possible. In case of persistent cycle control problems, a switch to the 30 micrograms EE2 drug should be considered.

Adult↗

Patient acceptability and satisfaction with Lunelle monthly contraceptive injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension).

The results from a User Satisfaction Questionnaire, Treatment Assessment Questionnaire, and Global Well-Being Schedule questionnaire administered to women participating in an open-labeled, nonrandomized, parallel, controlled study comparing a new monthly injectable contraceptive containing 25 mg of medroxyprogesterone acetate (MPA) and 5 mg of estradiol cypionate (E2C) (MPA/E2C) (Lunelle Monthly Contraceptive Injection) and a triphasic norethindrone (0.5, 0.75, 1.0 mg)/0.035 mg ethinyl estradiol (NET/EE) oral contraceptive (Ortho-Novum 7/7/7) are reviewed. Approximately 85% of all 1103 women enrolled in the comparative trial completed their initial and final questionnaires. To better assess the comparison of a new and extant method of contraception, outcome data were divided among MPA/E2C users and new and previous oral contraceptive (OC) users. Despite the inherent inequalities in comparing an injectable to an oral method of contraception, few treatment assessment and satisfaction outcomes were significantly different when comparing MPA/E2C users to new OC (NET/EE) users. More women in the MPA/E2C study group reported discomfort with their method than women in either NET/EE study group; however, only 19.4% of MPA/E2C users rated the administration of their contraceptive to be moderately uncomfortable or worse, compared to 11.7% of new NET/EE users and 13.4% of previous OC users. Among MPA/E2C users, 86.3% reported no interference with social activities compared with 90.4% of new NET/EE users. MPA/E2C and new NET/EE users were also similar in their responses recommending their respective contraceptive method to friends, with > 90% of both groups stating that they had a very favorable experience and would definitely recommend their method to a friend. In general, MPA/E2C was well accepted by women in the study group. Their attitudes and perceptions are similar to those of women who were starting OCs for the first time. These data support the premise that MPA/E2C may become a well accepted, first-line contraceptive option for women in the US.

Adolescent↗