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PubMed1988

Phase III-clinical trial with Norplant-2 (covered rods). Report of a 24-month study. National Programme of Research in Human Reproduction. Division of Human Resource Development Research Indian Council of Medical Research Ansari Nagar, New Delhi, India.

In a phase III multicentre clinical trial, the subdermal implant NorplantR-2 was studied for its clinical use effectiveness, safety and bleeding pattern. A total of 1466 healthy volunteers, with no contraindication to steroid use, were observed for 29,669 woman-months of use. One method failure was reported at 18 months of NorplantR-2 use. The method was associated with altered menstrual pattern with a trend towards reduced blood loss. The continuation rates were 88.1 and 73.5 per 100 users at 12 and 24 months of use, respectively. Menstrual disturbance, mainly prolonged bleeding, accounted for the majority of the discontinuations. Removal of NorplantR-2 due to local infection was rare (0.4 per 100 users at 24 months). In similar clinical trial conditions, the continuation rate with NorplantR-2 is significantly higher than those observed with LNG IUD and injectable contraceptives, norethisterone oenanthate 200 mg given every 60 +/- 5 days, and is comparable to that of CuT 200 IUD.

Adolescent↗
PubMed1979

Subnormal postconceptional levels of prolactin do not interfere with the early events of human pregnancy.

To elucidate the role of bromocriptine treatment and serum prolactin levels in peri-implantational events, 30 healthy women asking for "morning after" type contraception were given bromocriptine. Treatment was started 30.6 +/- 18.4 (mean +/- SD) hours after unprotected intercourse and continued until the next menstruation. Blood samples were taken before and 1 and 2 weeks after initiation of treatment, and the samples were assayed for concentrations of prolactin, progesterone, human chorionic gonadotropin (hCG), and pregnancy-specific beta1-glycoprotein (PSBG) by radioimmunoassay. Prolactin concentrations fell significantly (P less than 0.001) from the pretreatment level of 11.4 +/- 7.9 ng/ml (mean +/- SD) to 2.8 +/- 2.3 ng/ml at 1 week and to 1.9 +/- 0.6 ng/ml after 2 weeks of treatment. Five women had demonstrable hCG in serum 8 to 15 days after unprotected intercourse, and one of them also had PSBG 14 days postcoitum. Pregnancy advanced normally until legal termination in three women, whereas menstruation-like bleeding ensued in two. Our results suggest that neither bromocriptine treatment nor a subnormal maternal serum prolactin level interferes with the early development of human pregnancy.

Bromocriptine↗
PubMed2003

Pharmacologic properties of CDB(VA)-2914.

CDB(VA)-2914 (17alpha-acetoxy-11beta-(4-N,N-dimethylaminophenyl)-19-norpregna-4,9-diene-3,20-dione) is a synthetic steroid that demonstrates potent progesterone antagonist activity in vitro and in vivo. Its binding and antagonist potency with respect to the glucocorticoid receptor is significantly reduced compared to that of mifepristone, indicating that CDB(VA)-2914 belongs to a new class of dissociated progesterone receptor modulators that have reduced antiglucorticoid activity. The pharmacological effects of CDB(VA)-2914 have been examined in a variety of animal models, the results of which are reviewed in this paper. CDB(VA)-2914 inhibits ovulation in rats in a dose-dependent manner upon single-dose oral administration and exhibits antifertility activity during continuous low-dose administration. CDB(VA)-2914 is also effective in animal models of postcoital contraception. This paper also presents the results of metabolism studies undertaken to link the results of the animal models to potential human applications. Because of its unique pharmacological profile, CDB(VA)-2914 is a promising candidate for use in contraception as well as treatment of uterine fibroids and endometriosis.

Administration, Oral↗
PubMed2003

Smoking, estradiol metabolism and hormone replacement therapy.

Products for hormone replacement therapy (HRT) in the postmenopause are the second most frequently prescribed drugs in the USA. Among the women receiving this treatment many are smokers. In the Women's Health Initiative (WHI), one of the largest interventional studies on HRT to date and which recently had to be discontinued, 50% of the 8,500 women on HRT had smoked before or continued to smoke during the study. Remarkably, there is little knowledge about the impact smoking has on the efficacy and side effects of HRT. However, it has been proven that, depending on the type, duration and intensity of nicotine consumption, smoking can reduce or completely cancel the efficacy of orally administered estrogens. Not only does smoking diminish the otherwise well-established beneficial effects of estrogen on hot flashes and urogenital symptoms and its positive effects on lipid metabolism, i.e. by reducing cholesterol, but smoking also specifically reduces estrogen's ability to prevent osteoporosis. The reduction or loss of therapeutic efficacy is mainly caused by dose-dependently elevated hepatic clearance, partially in conjunction with lower estrogen levels, and has been demonstrated only with oral estrogen applications. This failure of therapeutic action should not be compensated for by increasing the dose in smokers as this might result in the production of toxic, even potentially mutagenic estrogen metabolites-compounds recently associated with a higher risk of breast cancer. The favorable effects of estrogens are not lost in smokers when they are applied transdermally. This route enables low dosage and also avoids the formation of unphysiological metabolites by bypassing the liver. Women who continue to smoke despite all warnings should therefore only be treated via the transdermal route. Oral contraceptives, but not HRT, are contraindicated in elderly smokers. However, the principal conclusion of the WHI study was that the lowest dose possible should be chosen, especially in patients with an increased cardiovascular risk, as is the case in smokers.

Aged↗
PubMed2005

Discovery of substituted isoxazolecarbaldehydes as potent spermicides, acrosin inhibitors and mild anti-fungal agents.

BACKGROUND: The continued endeavour to design novel, non-detergent molecules that can be useful as topical, prophylactic contraceptives has led to the discovery of substituted isoxazolecarbaldehydes as a new class of compounds exhibiting both spermicidal and acrosin inhibitory activities simultaneously. METHODS: Normal human semen samples were used to detect the spermicidal and acrosin inhibitory activities of the new compounds. Lactobacillus, HeLa and Candida cultures were used to determine the safety of compounds towards normal vaginal flora, their cytotoxicity and anti-fungal activity. Supravital staining and the hypo-osmotic swelling test (HOST) were used to detect the effect on sperm membrane integrity. Nonoxynol-9 (N-9) was used as a reference standard. RESULTS: The 5- and 3-substituted isoxazolecarbaldehydes showed significant spermicidal [minimum effective concentration (MEC)=0.005-2.5%] and acrosin inhibitory (IC50=3.9-58 x 10(-4) mol/l) activities in several molecules along with weak fungicidal activity against Candida albicans. Lineweaver-Burk and Dixon plot analysis of a representative structure showed non-competitive inhibition of human acrosin enzyme, and the most potent acrosin inhibitors also considerably diminished the induction of the acrosome reaction by Ca2+ ionophore. Some compounds were found to be significantly safer than N-9 towards Lactobacillus acidophilus in vitro at their respective spermicidal MECs. In the cytotoxicity assay, the IC50 of these compounds towards the HeLa cell line was of the same order as N-9 (0.9-0.1 mmol/l); however, in contrast, the compounds exhibited only a moderate effect on sperm membrane integrity. CONCLUSIONS: This study indicates that 5- and 3-substituted isoxazolecarbaldehydes are 'first generation' multifunctional, spermicidal molecules that hold promise for development as topical contraceptives with useful associated activities that can add considerably to their effectiveness, safety and prophylaxis.

Acrosin↗
PubMed2005

Smoking, estradiol metabolism and hormone replacement therapy.

Many women receiving hormone replacement therapy (HRT) smoke; in the Women's Health Initiative (WHI), one of the largest interventional studies on HRT to date and which recently had to be discontinued, 50% of the 8,500 women on HRT had smoked before or continued to smoke during the study. Remarkably, there is little knowledge about the impact smoking has on the efficacy and side effects of HRT. However, it has been proven that, depending on the type, duration and intensity of nicotine consumption, smoking can reduce or completely cancel the efficacy of orally administered estrogens. Not only does smoking diminish the otherwise well-established beneficial effects of estrogen on hot flashes and urogenital symptoms and its positive effects on lipid metabolism, i.e. by reducing cholesterol, but smoking also specifically reduces estrogen's ability to prevent osteoporosis. The reduction or loss of therapeutic efficacy is mainly caused by dose-dependent elevated hepatic clearance, partially in conjunction with lower estrogen levels, and has been demonstrated only with oral estrogen applications. This failure of therapeutic action should not be compensated for by increasing the dose in smokers as this might result in the production of toxic, even potentially mutagenic estrogen metabolites--compounds recently associated with a higher risk of breast cancer. The favorable effects of estrogens are not lost in smokers when they are applied transdermally. This route enables low dosage and also avoids the formation of unphysiological metabolites by bypassing the liver. Women who continue to smoke despite all warnings should therefore only be treated via the transdermal route. Oral contraceptives, but not HRT, are contraindicated in elderly smokers. However, the principal conclusion of the WHI study was that the lowest dose possible should be chosen, especially in patients with an increased cardiovascular risk, as is the case in smokers.

Administration, Cutaneous↗
PubMedDate not supplied

The hormone continuum: accrual of women's health benefits.

The hormone continuum is a treatment strategy that advocates maintaining hormone continuity, from the reproductive years into menopause and beyond. This entails the use first of oral contraceptives (OCs), which confer well-known health benefits--especially reductions in ovarian and endometrial cancers--besides effective contraception, and later, hormone replacement therapy (HRT), which provides relief of perimenopausal and menopausal symptoms and protects older women from (a) decreasing bone mineral density; (b) cardiovascular disease, according to several studies; and (c) Alzheimer's disease, as suggested by a number of studies. In perimenopause, use of OCs declines by about one-half, and then by a further four-fifths up to menopause. This is unfortunate, because in these later reproductive years women are subject to unintended pregnancy, which in 65% of cases is terminated by abortion. Furthermore, women are thereby deprived also of alleviation of dysmenorrhea and even vasomotor symptoms that often characterize the perimenopause. After menopause is well established, a "seamless" transition to HRT can be made, often with the same progestin that was contained in the OC. This paper discusses risks as well as benefits of hormone therapy, especially of HRT, with an emphasis on patient counseling and individualizing of therapy.

Adult↗
PubMed1979

[Long-term observations on use-effectiveness of copper-IUD's (author's transl)].

Long-term observation of the use-effectiveness and safety of 745 Copper-IUD's has demonstrated: 1) The pregnancy rate decreases distinctly after 2 years; until now no pregnancy has been observed after 4 years continuous use. 2) The endometrium responds first with an inflammatory reaction, later it shows signs of deficient secretion, but after a longer period seems to become normal again. 3) Contamination of IUD's begins early, mostly with bacteria of vaginal origin, later the number of sterile IUD's increases. -- A septic abortion after pregnancy with an IUD in situ has not occurred amongst our cases. 4) The rate of copper elution continues steadily, but in spite of demonstrable corrosion there is no obse-vable decrease of contraceptive effectiveness. Copper-IUD's can remain as long as 5 years in situ, if no untoward side effects (pain, bleeding, infection) occur. It may be advisable to remove them after that period as corrosion may affect devices at present commercially available.

Endometritis↗
PubMed2006

The provision and funding of contraceptive services at publicly funded family planning agencies: 1995-2003.

CONTEXT: Publicly funded family planning agencies face significant challenges in delivering quality services to low-income women because of the higher costs of newer contraceptive methods, changes in health care financing and a growing uninsured population. METHODS: In 2003, 627 of a nationally representative sample of 956 U.S. agencies receiving public funding for family planning services responded to an eight-page survey. Responses were compared with results from similar surveys in 1995 and 1999 to describe changes in the availability of contraceptive methods, policies on method provision and funding issues. Variation was examined by agency type and Title X funding status. RESULTS: Between 1995 and 2003, the number of contraceptive methods available to women increased and agencies reduced barriers to oral and emergency contraceptives by liberalizing policies for their provision. By 2003, many agencies offered the newest contraceptive methods available-the progestin-only IUD (58%), the patch (76%) and the vaginal ring (39%). However, more than half of agencies did not stock certain methods because of their cost, and some key funding sources had declined. Between 1995 and 2003, the proportion of agencies receiving Medicaid funding fell from 91% to 80%, and the proportion of clients paying full fee for their contraceptive services fell from 19% to 14%. The share of agencies waiving fees for adolescents fell from 66% in 1999 to 44% in 2003. CONCLUSIONS: Continued funding challenges limit the ability of publicly funded providers to offer all available methods to all women.

Adolescent↗
PubMed1977

Metabolism of methionine in oral contraceptive users and control women receiving controlled intakes of vitamin B6.

The metabolism of methionine was studied in 10 control and in 14 women using estrogen-containing oral contraceptives during 28 days of vitamin B6 deficiency and then for another 28 days while ingesting the same diet with daily supplements of 0.8, 2.0, or 20.0 mg of pyridoxine hydrochloride. Urinary cystathionine excretion after a 3-g load of L-methionine increased promptly in both groups and continued to increase throughout the 28 days of vitamin B6 depletion; there was no significant difference in the amount excreted by controls and oral contraceptive users. Two milligrams of pyridoxine-HCl restored the cystathionine excretion to predepletion levels within three to four weeks for both control and oral contraceptive users. Daily supplements of 0.8 mg of pyridoxine-HCl for as long as four weeks failed to restore cystathionine excretion to normal levels for either controls or contraceptive users; supplements of 2.0 mg met the vitamin B6 requirements for both groups. Urinary methionine, cysteine sulfinic acid, and taurine excretion did not differ significantly between the two groups at any time. The data indicate that oral contraceptive users are not generally different from non-users with respect to vitamin B6 requirements as evidenced by methionine metabolism.

Adult↗
PubMed1967

Clinical evaluation of a new sequential oral contraceptive agent.

One hundred and seventy-eight patients were placed on a new sequential oral contraceptive preparation (Ortho-Novum SQ) and observed through a total of 1785 months in an effort to determine the effectiveness of the agent and its acceptability to patients. Patients with varicose veins and/or previous thrombophlebitis were not excluded from the study. The most frequent side effect was "breakthrough bleeding" which occurred in 19 patients. One patient became pregnant while apparently taking the tablets as directed, and another was already pregnant when started on the drug. However, in spite of at least four weeks' continued ingestion after conception, both gave birth to normal female infants. Chloasma, noted in four patients while on combination oral contraceptives, cleared on this medication. There was no aggravation of thrombophlebitis or varicose veins. The acceptance of this sequential preparation by patients was excellent.

Adult↗
PubMed1999

Explanations of unmet need for contraception in Chitwan, Nepal.

This article explores reasons why women's fertility preferences and their contraceptive behaviors often appear to be contradictory. Ninety-eight separate interviews with women and their husbands conducted in rural Chitwan District, Nepal, over a 12-month period in 1993-94 revealed that people continually and self-consciously weigh the perceived benefits and risks of practicing family planning relative to their situations. Temporary and, especially, hormonal methods are perceived to carry unacceptable health risks. Contraceptive technologies are evaluated in relation to competing priorities and interests. Household poverty heightened the perceived risk of family planning use; poor people fear they can ill afford negative effects to their health that might result. People assess their health status and physical workload, factors that they believe condition their ability to use family planning methods without experiencing damaging health effects. Strategies employed to lower contraceptive risk include altering the method of choice, manipulating relationships with spouses, timing the adoption of contraceptives, managing the context of service provision, and acting in light of the experiences of others. Qualitative findings from the fieldwork are complemented by analysis of data from a standardized fertility survey.

Adult↗
PubMed1985

Postpartum IUD insertions in Manila, Philippines.

In comparative IUD trials conducted in the Philippines, IUDs were inserted immediately postpartum (within ten minutes postplacenta). The first study was designed to compare the IPCS-52 mg (Intrauterine Progestasert Contraceptive System) IUD with the TCu200 when inserted either by hand or with an inserter. Follow-up continued for three years because the IPCS model was designed to release progesterone for this length of time. There was one suspected pregnancy for which the IUD was removed during the study period. The expulsion rates were higher in the IPCS groups than in the TCu groups (p less than or equal to 0.05) and they were higher in the hand insertion groups than in the inserter groups (p less than or equal to 0.05). The second study was a comparison of the Lippes Loop D and a Delta Loop, modified by the addition of three biodegradable suture projections (made of Ethicon #2 chromic material) on the upper arms of the device. The purpose of this modification was to lower the expulsion rates associated with postpartum insertions. The expulsion rates for these two devices were comparable. There were no difficulties during insertion in either study, and few complaints were reported at follow-up. These two studies demonstrated that immediate postpartum IUD insertion proved a safe, effective means of postpartum contraception.

Adult↗
PubMed1994

Spermicides and barrier contraception.

The contraceptive failure rate of condoms varies from 2 to 13%, depending on the study population, yet it is the contraceptive method with the greatest capacity to protect against sexually transmitted diseases (STDs) and AIDS. Breakage and slippage during intercourse are important causes of failure, and individual behavior leading to consistent and correct use is the most important factor in condom effectiveness. Female-controlled barrier methods may actually prevent more STDs than condoms, because of their more consistent use. Using the diaphragm continuously and without spermicide was well accepted and effective in preventing pregnancy in one study. The female condom appears to have a contraceptive effectiveness close to that of other vaginal methods. It is likely that it also protects against STDs and AIDS. Nonoxynol-9 appears to have a protective effect against some STDs and the data concerning the protective effect of spermicides containing nonoxynol-9 against HIV is conflicting, yet suggests some protection, especially if products are used with relatively low frequency that avoids dose-dependent vaginal irritation. New spermicides which could also protect against viral infection without affecting epithelial cells are currently being studied.

Acquired Immunodeficiency Syndrome↗
PubMed1983

The Food and Drug Administration and medroxyprogesterone acetate. What are the issues?

In 1978, the Food and Drug Administration denied approval of the three-month injectable contraceptive depot medroxyprogesterone acetate for use in the United States. This decision goes against the advice of the FDA's own scientific advisory panels, as well as the rulings of the World Health Organization and the drug regulation institutions of more than 70 developed and developing countries. In response to protest from the manufacturer of depot medroxyprogesterone acetate and from many health professionals, the FDA took the unusual step of scheduling a public board of inquiry to review its decision in January 1983. Reviewing the scientific literature on the risks and benefits of depot medroxyprogesterone acetate, we find no reason to deny depot medroxyprogesterone acetate approval, provided that studies of its possible side effects are continued and that women use it only after having made an informed choice between this and other methods of contraception.

Delayed-Action Preparations↗
PubMedDate not supplied

Effect of acute androgen withdrawal by GnRH antagonist on epididymal sperm motility and morphology in the cynomolgus monkey.

Hormonal male contraception requires an induction phase before azoospermia and contraceptive safety are achieved. The nature of spermatozoa that may be ejaculated during this induction phase was studied in a nonhuman primate. The GnRH antagonist Cetrorelix was administered daily to five cynomolgus monkeys to induce testicular regression, and the vehicle was given to five control animals. Within 16 days, the antagonist reduced androgens by 80% in the serum and by 50% in the epididymis. Sperm were obtained by mincing different epididymal regions and were examined for morphology (subjectively) and motility (objectively) after removal of the organs 16 and 25 days after continuous treatment. Spermatozoa entering the epididymis of monkeys undergoing regression differed from those of vehicle-treated controls in their greater susceptibility to disruption during preparation for morphological staining. The acquisition of motility by sperm in the epididymides attached to regressing testes occurred in the same epididymal region as controls but did not achieve the median velocities attained by sperm in controls during epididymal passage. Values for most sperm motion parameters developed as in the controls, and, during epididymal passage, sperm developed resistance to stresses encountered during preparation for morphological analysis. These observations suggest that spermatozoa ejaculated before spermatogenesis ceases may be potentially fertilizing because epididymal maturation continues in an androgen-deprived organ. From these preclinical studies, it can be concluded that in men, applying hormonal contraception precautions against pregnancy must be recommended before azoospermia is induced, since the epididymis can partially compensate for poor-quality sperm produced by a regressing testis even when levels of circulating androgens and tissue androgens are low.

Androgen Antagonists↗