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Spermicidal effects of amphotericin B and nystatin on bull and rabbit sperm and contraceptive effects in rabbits.

Vaginal contraceptives have potential for controlling reproduction as well as sexually transmitted diseases. Two extensively used fungicides, amphotericin B and nystatin, were found to be highly spermicidal to bull and rabbit sperm even in the presence of organic material found in milk and egg yolk, both excellent components of media designed to preserve sperm. In repeated tests with many samples of bull and rabbit sperm, as little as 0.5 micro g/mL of amphotericin B completely immobilized sperm after prolonged exposure, and 1000 micro g/mL immobiled sperm in less than 1 min. Treatment of rabbit sperm with 1000 micro g of solubilized amphotericin B in 0.4 ml of a glucose-semen mixture before insemination resulted in a total of 2 young born from 9 inseminated Dutch does, compared with 55 young from 9 control does. As this inhibition was achieved without the use of enhancing foams or gels, these results provide promising leads for contraceptive research.

Amphotericin B↗

Flexible starting schedule for oral contraception: effect on the incidence of breakthrough bleeding and compliance.

OBJECTIVE: To compare the effect of starting oral contraceptives on the first day of menses with the effect of starting on the day of menses' cessation (but no later than the 5th day following its onset), on the incidence of early breakthrough bleeding. METHOD: Oral contraceptives containing 30 micrograms ethinylestradiol and 75 micrograms gestodene were prescribed to 200 consecutive healthy women in whom oral contraceptives were found to be the most suitable method of contraception. In the first 100 women, treatment was started on the 1st day after the onset of menses (Day 1 group), and in the remainder, treatment was started on the day of menses' cessation, but no later than the 5th day following its onset (Flexible group). RESULTS: The Flexible group had better compliance and a reduced incidence of breakthrough bleeding. No differences were observed between the two groups for age, parity and gravity, or contraceptive failure. CONCLUSIONS: Oral contraceptives may be initiated on the day of menses' cessation, but no later than the 5th day following its onset. This regimen might increase patient compliance and lower the incidence of breakthrough bleeding, probably without adversely affecting contraceptive efficacy.

Adolescent↗

Timing of onset of contraceptive effectiveness in Norplant implant users. Part I. Changes in cervical mucus.

OBJECTIVE: To provide scientific data regarding the changes in cervical mucus within the first hours to days after Norplant implant insertion and to estimate when the cervical mucus is hostile enough to suggest a contraceptive effect. DESIGN: Multicenter, clinical descriptive study. SETTING: Family planning clinics. PATIENT(S): Forty-two women who were between days 8 and 13 of their menstrual cycle and who had requested Norplant implants were admitted to the study. INTERVENTION(S): Cervical mucus and blood samples were obtained. MAIN OUTCOME MEASURE(S): Cervical mucus scores, sperm penetration distances, and serum levels of progesterone, estradiol, and levonorgestrel. RESULT(S): The median cervical mucus score observed at baseline was 6 ("fair"), indicating that the mucus was already somewhat hostile before insertion of the Norplant implants. The median scores declined to 5 at 12 and 24 hours and continued to decrease through day 7 to 2 ("poor"), a score that is judged as hostile to sperm penetration. Overall, 73% of all subjects had a poor cervical mucus score by 3 days after insertion; at 7 days after insertion, 90% exhibited poor mucus and none had a good score. There was a substantial drop in the overall median distance traveled by the vanguard sperm after 12 hours for each cervical mucus score grouping. The distance traveled decreased rapidly between 12 and 24 hours to < 0.5 cm in subjects with fair and poor mucus, and by day 3, 91% of the subjects exhibited poor sperm penetration. CONCLUSION(S): On the basis of our findings, deterioration of the quality of the cervical mucus and sperm penetration is evident by 24 hours after insertion, although not to a level that would suggest adequate protection until 72 hours after insertion. Therefore, we are confident in recommending that backup methods of contraception (e.g, condoms) need not be used for more than 3 days after insertion, even when the implants are inserted close to ovulation. These findings provide policy makers, clinic managers, and clinicians with important information about how they can improve client access to Norplant implants.

Adult↗

Proniosome based transdermal delivery of levonorgestrel for effective contraception.

A proniosome based transdermal drug delivery system of levonorgestrel (LN) was developed and extensively characterized both in vitro and in vivo. The proniosomal structure was liquid crystalline-compact niosomes hybrid which could be converted into niosomes upon hydration. The system was evaluated in vitro for drug loading, rate of hydration (spontaneity), vesicle size, polydispersity, entrapment efficiency and drug diffusion across rat skin. The effect of composition of formulation, amount of drug, type of Spans, alcohols and sonication time on transdermal permeation profile was observed. The stability studies were performed at 4 degrees C and at room temperature. The biological assay for progestational activity included endometrial assay and inhibition with the formation of corpora lutea. The study demonstrated the utility of proniosomal transdermal patch bearing levonorgestrel for effective contraception.

Administration, Cutaneous↗

Contraceptive effectiveness of two spermicides: a randomized trial.

OBJECTIVE: We conducted a multinational randomized trial to determine whether a spermicidal film containing 72 mg of nonoxynol-9 per film was at least as effective in preventing pregnancy as a foaming tablet containing 100 mg of nonoxynol-9 per tablet. METHODS: Between September 1995 and July 1997, 765 women aged 18-35 years who had no evidence of subfecundity were randomly assigned to use one of the two spermicides as their only contraceptive method at every coital act for 28 weeks. Participants were asked to keep coital diaries throughout the study period. Pregnancy tests were performed on a scheduled basis. Each participant was followed for 28 weeks or until she stopped considering the spermicide as her primary method of contraception. RESULTS: The Kaplan-Meier estimate of the 6-month probability of pregnancy during typical use of the spermicide was 28.0% in the tablet group and 24.9% in the film group (P = .78, one-tailed test). The study had nearly 75% power to have detected a difference of seven percentage points between groups. Results were almost identical when the analysis included only months when the participants reported use of the spermicide during every coital act. Reported levels of sexual activity and compliance with use of the spermicide were high in both groups. CONCLUSION: The contraceptive effectiveness of these two spermicidal products appeared similar. Both products were associated with a fairly high risk of pregnancy in this young, highly sexually active population.

Adolescent↗

Predicting effective contraceptive behavior in college females.

This article reports the results of a preliminary research project that explored the relationship between assertiveness, cognitive development and contraceptive behavior among single young women in their freshman and senior years at college. A total of 60 college women at a university health center volunteered to participate in this pilot study. They filled out three instruments: the Galassi College Self-Expression Scale (SES), the Measure of Intellectual Development (MID) tool and an author-developed sexuality questionnaire. Although there was a significant relationship between cognitive development and assertiveness, no significant relationships were found between cognitive development, assertiveness and use of effective contraception. Interesting descriptive characteristics were identified. Clinical implications are discussed.

Adolescent↗

Effective contraception with the levonorgestrel-releasing intrauterine device: 12-month report of a European multicenter study.

The use-effectiveness of an intrauterine contraceptive device releasing 20 mcg of levonorgestrel daily (Lng-IUD), and of a Nova T copper-releasing IUD, were studied in a randomized, comparative multicenter trial. The Lng-IUD was inserted in 1821, and the Nova T in 937 women. The 12-month net pregnancy rate with the Lng-IUD (0.1 per hundred women) was significantly lower than that with the Nova T (0.9 per hundred). Removal rates for menstrual problems and/or pain were similar for the two methods (net rates 7.5 and 8.7, respectively). The 12-month continuation rates were 82.2 for the Nova T and 79.7 for the Lng-IUD. The reduction of the bleeding led to oligomenorrhea and amenorrhea in users of the Lng-IUD; the removal rate for these reasons was 1.4. The removal rate for hormonal side effects with the Lng-IUD was 2.4. Blood hemoglobin concentrations increased among users of the Lng-IUD and decreased among users of the Nova T. The results show that the Lng-IUD was a highly effective contraceptive method which reduced menstrual bleeding. It is a promising alternative for women desiring a highly effective method for long-term use.

Adult↗

[Contraceptive effect of low-dosage ovulation inhibitors containing various progestagen agents].

The decrease of steroid dosage in oral contraceptives resulted in a decrease of serious side effects with continued effectiveness. However, a increase in subjectively disturbing bleeding abnormalities occurred at the same time. The development of triphasic preparations was designed to eliminate these abnormal bleeding episodes by stepwise changes of the estrogen and progestagen doses. Compared to the low dosage combination preparation, triphasic preparations show often a persistence of insufficiently suppressed hormone levels in single determinations but not in mean averages of determinations. This could be an explanation for the reported pregnancies. In spite of these results, the literature reports rare failures during the administration of the triphasic preparations and additional factors could determine the contraceptive effectiveness.

Adolescent↗

How effective are contraceptives? The determination and measurement of pregnancy rates.

OBJECTIVES: To provide an overview of contraceptive effectiveness and its determinants as well as reasons for the gap between the actual and expected number of unplanned pregnancies for various categories of users; to provide some guidelines for more precise, consistent terminology and measurements for use in future research; and to provide specific counseling guidelines; using combined oral contraceptives (OCs) as the example. DATA SOURCES: Fifty-three articles on contraceptive effectiveness were reviewed, with a particular focus on pregnancy rates among OC users and the quality of use contributing to those rates. Definitions and measurement of contraceptive effectiveness, its components, and its determinants were examined and discrepancies explored. METHODS OF STUDY SELECTION: Papers discussed were selected because they had special relevance. Only a few of the papers discussed in this article were quantitative studies of contraceptive behavior and effectiveness. Others were review articles, discussions of the appropriate measurement of various components of effectiveness. Others provided conceptual frameworks for studying method effectiveness. All published studies of OC compliance were reviewed. TABULATION, INTEGRATION, AND RESULTS: Comparing the definitions and measurement of both compliance and effectiveness revealed important inconsistencies. However, some trends did emerge, and these papers did provide a framework for the following discussion. The findings were used to develop a more coherent set of definitions, measurement approaches, and counseling strategies. Characteristics of the user, the method, and the service delivery system all play a role in contraceptive effectiveness. However, it is the quality of use, ie, the user's own behavior, that is the immediate determinant of the effectiveness of any short-term contraceptive method. The mean pregnancy rate for better-than-average users is 4%; for poorer-than-average users, it is 8%. CONCLUSIONS: The range of contraceptive effectiveness rates is closely associated with user characteristics. Oral contraceptive users need to know that their own chance of becoming pregnant will vary with their fecundability, when and how frequently they have sexual intercourse, and, especially, how consistently and correctly they take their pills. The likelihood that any one user will take OCs correctly and consistently also is associated with her life-style, socioeconomic status, age, and other factors. Further research is needed to determine how forgiving OCs are of various pill-taking errors, to determine the impact of dual method use (eg, OCs and condoms), and to assess the effects of user, method, and programmatic characteristics on correct and consistent use and, in turn, on effectiveness.

Adolescent↗