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A comparative evaluation of the safety and contraceptive effectiveness of 65 mg and 100 mg of 90-day norethindrone (NET) injectable microspheres: a multicenter study.

The first of a second generation of slow-release injectable contraceptives is the norethindrone (NET) microspheres with a 90-day duration of action. It was evaluated at 65-mg and 100-mg doses for safety and contraceptive effectiveness in two randomized, single-blind trials among 131 women: 94 women for 12 months and 37 women for 6 months. The 6-month trial included additional evaluations of ovarian function and serum NET values. In the 6-month trial, no indication of ovulation was detected in the 100-mg dose group, while 3 of the 19 women in the 65-mg group showed signs of ovulation (progesterone greater than 3 ng/ml). No pregnancies were reported in the 100-mg group and one pregnancy in the 65-mg group resulted in a life-table pregnancy rate for that dose of 2.6 per 100 woman-years (95% confidence interval, 0 to 7.5). Days of vaginal bleeding were analyzed for 30 days before treatment and in 90-day reference periods after treatment. The mean number of vaginal bleeding and spotting days increased initially after the first injection in both dose groups, but decreased to below baseline in both dose groups after 6 months. The two doses appear comparable in clinical safety, side effects, vaginal bleeding patterns, and laboratory measures. With the preliminary estimate of efficacy, the 65-mg dose would be the minimally effective dose for the NET 90-day injectable contraceptive.

Adult↗

The contraceptive effects of a new low-dose combination type oral contraceptive.

A study was carried out in 9 women volunteers to investigate the centron of 0.75 mg lynestrenol plus 0.0375 mg ethinyl oestradiol given for 22 days per cycle over a period of 6 cycles. The results of assessments of a number of hormonal, vaginal and cervical parameters showed that this combination has a two-fold effect: a central effect on the pituitary and a peripheral effect on the ovaries and on endometrial development. The findings of an effect on cervical mucus, as with higher dose combinations, were not sufficiently consistent to warrant a claim for a cervical barrier. The preparation appeared to be well tolerated but there was a high incidence of irregular bleeding in the first treatment cycle. In most of the women, however, this had corrected itself by the second cycle.

Adult↗

Barriers to effective contraception and strategies for overcoming them among adolescent mothers.

Young women often have difficulty accessing and correctly using contraception. However, these difficulties are not primarily the result of lack of knowledge or experience of contraception. In this study, nine adolescent mothers were interviewed about their experience of contraception before and after the birth of their children. These adolescent women faced barriers to effective contraceptive use before the birth of their children. These barriers included indifference to the possibility of pregnancy, perceived invulnerability to pregnancy, and forgetting to use contraception regularly. Analysis also revealed that during the time these women were sexually active prior to pregnancy, many had used a range of strategies to overcome these barriers to effective contraception, including using adult support, allowing an adult to take responsibility for contraception, and using multiple methods of contraception to cover for contraceptive failure. The strategies used by these women to delay childbearing indicate valuable areas for further research in preventing unplanned adolescent pregnancy.

Adolescent↗

An incremental-dose combined oestrogen-progestogen oral contraceptive: effects on body weight, blood pressure, and biochemical parameters.

An evaluation is presented of the effects of an incremental-dose combined oestrogen-progestogen contraceptive (0.05 mg ethinyl oestradiol throughout the cycle plus d-norgestrel 0.05 mg for the first 11 days and 0.125 mg for the subsequent 10 days). The majority of women showed weight changes less than 1.0 kg; a weight gain in excess of 2 kg was observed in 11.4% and a similar loss in 14.3%. The net change in blood pressure after 12 months was a slight reduction; no excessive elevation of pressure was recorded. Although no significant change in glucose tolerance was noted, triglyceride levels became progressively elevated; the increase in cholesterol levels were observed mainly in the second half of the cycle. Changes occurred in some but not all haematologic parameters: a significant increase in plasminogen level and decrease in activated prothrombin time; factors 7, 9 and 10 were progressively increased, whereas factors 5, 8, fibrinogen and antithrombin activity remained unaltered. This new preparation provides effective contraception with satisfactory cycle control and body weight changes. It is particularly useful in women who require additional oestrogen.

Blood Coagulation Factors↗

Is the contraceptive effect of 300 micrograms of norethisterone mainly peripheral or central?

The effect of norethisterone (NET) on pituitary function was evaluated by measuring circulating follicle stimulating hormone (FSH) and luteinizing hormone (LH) during the mid follicular phase as well as before and after removal of the corpus luteum (CL) in 30 untreated women and 43 women treated with 300 micrograms of NET daily for three months. All untreated women exhibited significantly elevated FSH levels after removal of the CL irrespective of the stage of the luteal phase. In the NET-treated women, the levels of FSH were significantly raised in women with luteal activity but these levels were not influenced by the operative procedure in those women without luteal activity. The LH levels remained unchanged after removal of the CL in both untreated and NET-treated women. The results suggest that a low dose of gestagen exerts variable effects on pituitary function. The main contraceptive effect seems to be through direct interference with ovarian function.

Adult↗

Acceptance of effective contraceptive methods after induced abortion.

The purpose of this study was to examine possible motivating factors in switching from a relatively inadequate contraceptive method to an effective one. Three groups of women were observed: Group A had induced abortion and routine family planning education; Group B had induced abortion, routine family planning education, and special education on the health hazards of abortion; and Group C had no abortion, but did have both the routine and special education. The rate of women switching from inadequate contraceptive methods to the more effective methods was 45, 86, and 18 percent, respectively. Thus, these findings demonstrate that women who have had induced abortion are more highly motivated to switch from inadequate to effective contraceptive methods, particularly when they have been exposed to routine family planning education and additional education on the health hazards of abortion. It is recommended that emphasis be placed on providing special education for women who have had induced abortion.

Abortion, Induced↗

Communicating contraceptive effectiveness: A randomized controlled trial to inform a World Health Organization family planning handbook.

OBJECTIVE: The objective of the study was to compare 3 different approaches for increasing clients' understanding of contraceptive effectiveness. STUDY DESIGN: We randomized 900 reproductive-age women in India and Jamaica to 1 of 3 charts presenting pregnancy risk. RESULTS: The most important reason for choosing a contraceptive was how well it prevents pregnancy (54%) followed by few side effects (17%). At baseline, knowledge about contraceptive effectiveness was poor. About half knew oral contraceptive pills are more effective than condoms (46%) and intrauterine devices are more effective than injectables (50%). All 3 charts improved knowledge significantly (P < .01) for these 2 questions. No chart improved knowledge better than any other (P > .05). The chart ranking contraceptive methods on a continuum was judged slightly easier to understand than the other 2 charts. CONCLUSION: Only with accurate understanding of pregnancy risk can clients make informed choices. Our results have already informed a global handbook for family planning providers to use the chart ranking contraceptive methods on a continuum.

Adolescent↗

Problem-solving skills, locus of control, and the contraceptive effectiveness of young women.

It was proposed that the lack of insight into the risk-taking behavior of many sexually active women who do not want to get pregnant may reflect the lack of an adequate framework from which to investigate the problem. The purpose of this study was to examine the relationships between contraceptive effectiveness and several cognitive factors. The sample consisted of 155 single women, 15.3-25.7 years of age, from a Planned Parenthood clinic and an abortion clinic. Contraceptive effectiveness, operationally defined as the number of unplanned pregnancies in a woman's history, was significantly and negatively related to means-ends problem-solving ability and a belief in internal control and significantly and positively related to a belief in chance control. It was suggested that these results support the utility of a cognitive, problem-solving approach to the study of contraceptive behavior.

Abortion, Induced↗

The impact of the quality of family planning services on safe and effective contraceptive use: a systematic literature review.

The aim of this review is to identify the features of family planning service provision that are influential in ensuring safe and appropriate contraceptive use and optimal effectiveness of user-dependent methods. A systematic search was carried out of the published and unpublished studies available up to December 1997 that examined the relationship between family planning service provision and contraceptive use. Articles that reported primary data on long-term outcomes were scored by at least two of the authors of the present study. Particular attention was paid to evaluating methods of measuring quality of care. A total of 142 articles were identified, but only 16 reported primary data relating to long-term outcomes. The quality of provider--client exchanges was found to have a net incremental effect on contraceptive use. Evidence of effectiveness of methods to improve uptake, continuation of method use, and safe and appropriate use of fertility control is scant. The evidence that is available indicates that training in communication with clients (particularly about side-effects of contraceptive methods) and an emphasis on client choice are key components of effective interventions. The tasks of listening to clients, and tailoring services to local needs, are crucial to the success of family planning service provision.

Journal Article↗

Combination contraceptives: effects on weight.

BACKGROUND: Weight gain is often attributed as a side effect of combination hormonal contraceptive, and many women and clinicians believe that an association exists. Concern about weight gain can limit the use of this highly effective method of contraception by deterring the initiation of its use and causing early discontinuation among users. Nevertheless, a causal relationship between combination contraceptives and weight gain has not been established. OBJECTIVES: The aim of the review was to evaluate the association between combination contraceptive use and changes in weight. SEARCH STRATEGY: We searched the computerized databases MEDLINE, Popline, CENTRAL, EMBASE, and LILACS for studies of combination contraceptives. We also wrote to known investigators and manufacturers to request information about other published or unpublished trials not discovered in our search. SELECTION CRITERIA: All English-language, randomized controlled trials at least three treatment cycles in duration that compared a combination contraceptive to a placebo or with a combination contraceptive that differed in drug, dosage, regimen, and/or study length were eligible. DATA COLLECTION AND ANALYSIS: All titles and abstracts located in the literature searches were assessed. Data were entered and analyzed with RevMan 4.1, and a second reviewer verified the data entered. Depending on the data available, the weighted mean difference using a fixed effects model with 95% confidence intervals was calculated for the mean change in weight between baseline and post-treatment measurements or the Peto odds ratio with 95% confidence intervals was calculated using the proportion of women who gained or lost more than a specified amount of weight. MAIN RESULTS: The three placebo-controlled, randomized trials did not find evidence supporting a causal association between combination oral contraceptives or a combination skin patch and weight gain. Most comparisons of different combination contraceptives showed no substantial difference in weight. In addition, discontinuation of combination contraceptives because of weight gain did not differ between groups where this was studied. REVIEWER'S CONCLUSIONS: Available evidence is insufficient to determine the effect of combination contraceptives on weight, but no large effect is evident.

Body Weight↗

Combination contraceptives: effects on weight.

BACKGROUND: Weight gain is often considered a side effect of combination hormonal contraceptives, and many women and clinicians believe that an association exists. Concern about weight gain can limit the use of this highly effective method of contraception by deterring the initiation of its use and causing early discontinuation among users. However, a causal relationship between combination contraceptives and weight gain has not been established. OBJECTIVES: The aim of the review was to evaluate the potential association between combination contraceptive use and changes in weight. SEARCH STRATEGY: We searched the computerized databases MEDLINE, POPLINE, CENTRAL, EMBASE, and LILACS for studies of combination contraceptives. We also wrote to known investigators and manufacturers to request information about other published or unpublished trials not discovered in our search. SELECTION CRITERIA: All English-language, randomized controlled trials were eligible if they had at least three treatment cycles and compared a combination contraceptive to a placebo or to a combination contraceptive that differed in drug, dosage, regimen, and/or study length. DATA COLLECTION AND ANALYSIS: All titles and abstracts located in the literature searches were assessed. Data were entered and analyzed with RevMan, and a second author verified the data entered. Depending on the data available, the weighted mean difference using a fixed effects model with 95% confidence intervals (CI) was calculated for the mean change in weight between baseline and post-treatment measurements or the Peto odds ratio with 95% confidence intervals was calculated using the proportion of women who gained or lost more than a specified amount of weight. MAIN RESULTS: The three placebo-controlled, randomized trials did not find evidence supporting a causal association between combination oral contraceptives or a combination skin patch and weight gain. Most comparisons of different combination contraceptives showed no substantial difference in weight. In addition, discontinuation of combination contraceptives because of weight gain did not differ between groups where this was studied. AUTHORS' CONCLUSIONS: Available evidence was insufficient to determine the effect of combination contraceptives on weight, but no large effect was evident.

Body Weight↗

Contraceptive effects of Phyllanthus amarus in female mice.

Antifertility effects of an alcohol extract of the whole plant, Phyllanthus amarus at a dose of 100 mg/kg body weight for 30 days orally was investigated in cyclic adult female mice. The results revealed no -significant change in absolute body and organ weights in extract-fed animals, indicating no alteration in general metabolic status. Further, feeding had no effect on haematological and clinical biochemical tests reflecting its non-toxicity. Similarly, uterine and ovarian biochemical tests showed no change except in 3beta and 17beta hydroxy steroid dehydrgenase (HSDs) levels, probably affecting hormonal conversions in the latter. Cohabited females with normal male mice were unable to become pregnant as their cyclicity was affected. These factors are related to a change in the hormonal milieu that governs female reproductive function. Upon withdrawal of feeding for 45 days, these effects were reversible. Thus this extract manifests a definite contraceptive effect in female mice.

Animals↗

Development of a polymeric releasing device for 2'-carbomethoxyphenyl 4-guanidinobenzoate (a proteinase inhibitor): release rate, in vitro antifibrinolytic activity and in utero contraceptive effect.

A polymeric delivery system consisting of ethylene-vinyl acetate copolymer (EVAc) was developed for 2'-carbomethoxyphenyl 4-guanidinobenzoate (MSGB), a potent inhibitor of the sperm enzyme acrosin. The optimal device consists of copolymer with 40% vinyl acetate by weight (EVAc/40), 65% drug loading and MSGB with a particle size of 250-499 micron. This formulation yields a device that is highly flexible and can be shaped to many forms and sizes. Construction of the device does not alter the properties of MSGB. Well controlled release of MSGB from the device occurs in vitro and in the uteri of rats. The in vitro release rate under "infinite sink" conditions is essentially the same as the in vivo release rate. The contraceptive effect of the MSGB-releasing device was tested in rabbits by placing a blank (control) device in one uterine horn and an MSGB-releasing device in the contralateral horn. In contrast to blank devices, MSGB-releasing devices completely prevent pregnancy, not only by inhibiting fertilization but also by decreasing implantation. MSGB possesses high in vitro antifibrinolytic activity. These results indicate that a very flexible device can be constructed for uterine application which retains its contraceptive effect by release of MSGB. The antifibrinolytic activity of MSGB may further decrease the menorrhagia that can be associated with IUD use.

Animals↗

Safety evaluation of modern oral contraceptives. Effects on lipoprotein and carbohydrate metabolism.

An ideal oral contraceptive should either be neutral as regards metabolic risk markers for arterial disease or should only change them in directions that would be expected to reduce risk. Depending on their formulation, modern low dose oral contraceptives affect systems such as hemostasis, lipoprotein metabolism, and glucose and insulin metabolism. Some of these actions would be expected to decrease the risk of arterial disease and some might be expected to increase risk. Despite these associations there is at present no justification for widespread metabolic screening as a strategy to further improve oral contraceptive safety. Recent developments in atherosclerosis research support the introduction of progestogens such as desogestrel that allow the estrogenic increase in high density lipoprotein levels to persist and that may cause less of an elevation in plasma insulin responses to glucose. The predicted benefit of these formulations in terms of arterial disease is difficult to demonstrate in an epidemiological setting because of the rarity of the disease in young women.

Blood Glucose↗

Predicting male and female contraceptive behavior: a discriminant analysis of groups high, moderate, and low in contraceptive effectiveness.

An exploratory, multivariate study was carried out to assess (a) whether three contraceptive-effectiveness groups (high, moderate, and low) could be differentiated on the basis of variables that have been theoretically and empirically associated with contraceptive behavior and (b) whether an identified set of discriminating variables could accurately classify sexually active college students into these groups. Three hundred sixty-five sexually active, never-married college students (211 males and 154 females) completed instruments measuring variables related to contraception. Four separate discriminant analyses were performed, one for each sex for both their initial sexual encounter and their current sexual interactions. Discrimination and classification of the three contraceptive groups for both males' and females' initial sexual experience was not very successful. Moderate discrimination was achieved for the female current sexual activity subsample and good discrimination and classification was made for the currently sexually active male subsample. The results are discussed in terms of the implications of the findings for understanding contraceptive behavior of males and females, problems with the dependent variable of contraceptive use, and the mounting evidence that emotional orientation to sexuality influences contraceptive behavior.

Adult↗

Contraceptive effect of Curcuma longa (L.) in male albino rat.

AIM: To study the contraceptive effect of the crude extracts of Curcuma longa in male albino rats. METHODS: Rats were fed orally with Curcuma longa aqueous and 70% alcoholic extract for 60 days (500 mg x kg(-1) x day(-1)). RESULTS: A reduction in sperm motility and density was observed in both the treated groups. CONCLUSION: Curcuma longa may have affected the androgen synthesis either by inhibiting the Leydig cell function or the hypothalamus pituitary axis and as a result, spermatogenesis is arrested.

Animals↗