Vaginal ring delivering estradiol and progesterone: a possible alternative to relieve climacteric symptoms.
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BACKGROUND: Relief of climacteric symptoms is currently the main role of hormone therapy. However, vaginal bleeding complicating this therapy is among the leading causes for its early discontinuation. OBJECTIVES: To assess the effect of a vaginal ring delivering estradiol and progesterone in postmenopausal women and to determine whether continuous administration can relieve climacteric symptoms, produce an acceptable pattern of vaginal bleeding and control endometrial proliferation. METHODS: Twenty-nine postmenopausal women with an intact uterus were studied. All had climacteric symptoms. The vaginal rings contained 0.36 g estradiol and either 3.6 g progesterone (high dose progesterone) or 1.8 g (low dose progesterone), and were kept in place for 4-6 months. Serum progesterone, estradiol and estrone were measured and endometrial thickness determined. All women kept a daily diary of bleeding/spotting and completed a questionnaire on climacteric symptoms at monthly intervals. The low dose progesterone group comprised 14 women and the high dose progesterone group 15 women. RESULTS: A total of 18 patients (9 in each group) completed the study. Mean levels of estradiol, estrone and progesterone were at their peak after 2 to 4 weeks. All rings were effective in alleviating vasomotor symptoms, although there was evidence of "escape from effect" in month 6. Endometrial thickness increased in 6 of the 29 women but biopsy in each case showed no evidence of hyperplasia. Of the 18 women who completed the study, 5 had amenorrhea throughout, 7 had amenorrhea after 3 months, and the remainder had one or two bleeding episodes after 3 months. Therapy was discontinued in 11 women. CONCLUSIONS: A vaginal ring delivering estradiol and progesterone controlled climacteric symptoms, prevented endometrial proliferation, and provided an acceptable bleeding pattern. It should be viewed as a possible alternative for short-term estrogen-progesterone therapy. (+info)
Long-term, controlled release of the HIV microbicide TMC120 from silicone elastomer vaginal rings.
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OBJECTIVES: The feasibility of providing prolonged and controlled release of the experimental non-nucleoside reverse transcriptase inhibitor TMC120 from a silicone vaginal ring in quantities sufficient to maintain a vaginal concentration offering protection against heterosexual HIV transmission was investigated. METHODS: Core-type, silicone elastomer vaginal rings containing TMC120 were manufactured, and in vitro release studies performed under sink conditions. The experimental release data, as determined by HPLC, were correlated with estimates of vaginal TMC120 concentrations required to inhibit HIV replication. RESULTS: Continuous, zero-order release of TMC120 from core-type vaginal rings was observed in vitro over a 71 day period, equivalent to 136 microg/day. The release rate is predicted to maintain vaginal concentrations of the antiretroviral in the range of several orders of magnitude in excess of reported HIV inhibitory concentration values. CONCLUSIONS: Continuous and prolonged zero-order release of TMC120 from a silicone vaginal ring device at quantities predicted to prevent HIV infection was observed. (+info)
Acceptability and feasibility of continuous diaphragm use among sex workers in Madagascar.
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OBJECTIVES: The diaphragm, a woman controlled, reusable contraceptive device, might prevent some sexually transmitted infections (STIs). We assessed the acceptability and feasibility of use of silicone Wide-Seal Arcing Diaphragms (Milex Products, Chicago, IL, USA) by sex workers in Madagascar. METHODS: Over 8 weeks, we evaluated method acceptability by examining patterns of and problems with women's diaphragm use. We also evaluated several measures of study feasibility, including recruitment and follow up methods. RESULTS: 91 women from three cities (Antananarivo, Tamatave, and Mahajanga) participated, and 87 (96%) completed follow up. At enrolment, participants reported a median of six sex acts with five clients in the previous week. During the follow up period, participants reported a median of three sex acts with three clients during the previous 2 days, and self reported continuous diaphragm use during the previous day increased from 87% to 93%. Seven women became pregnant (incidence 53 pregnancies per 100 woman years). Self reported use of male condoms and diaphragms was fairly constant over the study period: women reported condom use in 61% to 70% of acts and diaphragms in 95% to 97% of acts. The number of participants reporting diaphragm problems decreased from 15 (16%) at the first visit to six (7%) at the final visit. 20 women (22%) needed replacement devices during follow up because their original diaphragms were lost, were the wrong size, or became seriously damaged. CONCLUSIONS: Given the high use and steady decrease in reported problems during the study, we believe diaphragms are acceptable and feasible in this resource poor, low education sex worker population. (+info)
FemCap with removal strap: ease of removal, safety and acceptability.
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OBJECTIVES: FemCap is a silicone-rubber barrier contraceptive approved for marketing in the United States. To address reported problems with removal and dislodgment, the device's developer added a strap to the device and increased the height of the brim. This trial assessed whether the new design reduced removal difficulties and had any effects on dislodgment, genital pain/discomfort, safety, and acceptability. METHODS: Women used the strapped device for 8 weeks with follow-up visits at 2 and 8 weeks. Outcome measures were obtained through diary cards, questionnaires, and naked eye examination. Data from these 120 women were compared with data from 419 women who used the unstrapped FemCap in a previous contraceptive effectiveness study. RESULTS: The strapped device was not significantly easier for users to remove than the unstrapped device. Similar odds of dislodgment and cervical/vaginal irritation were seen with the two devices. Both female and male participants were significantly more likely to report pain/discomfort with use of the strapped device. Female users of the strapped device were significantly more likely to say they disliked their device. In six weeks, two pregnancies were observed, but pregnancy was not an endpoint in the study and no conclusions should be drawn regarding pregnancy rates. CONCLUSIONS: The modifications to the FemCap did not significantly improve the ease of device removal and appears to have resulted in significantly more female and male partner pain/discomfort and decreased acceptability, compared with the unstrapped device. (+info)
Controlled vaginal delivery of antibodies in the mouse.
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Controlled delivery of monoclonal antibodies to the mucus secretions of the vagina might provide women with passive immunoprotection against both sexually transmitted diseases and unwanted pregnancy. We have developed intravaginal devices composed of poly(ethylene-co-vinyl acetate) (EVAc) that continuously release IgG antibodies for over 30 days into buffered saline, and we have tested these devices in the vagina of mice. Polymeric devices containing either BSA (as a test reagent for proteins) or anti-hCG antibody, when inserted into the vaginas of mice, provided a continuous supply of either BSA or hCG-binding antibodies to the vaginal mucus for 30 days. Antibodies released by the devices achieved high concentration in the mucus within the lumen of the vagina, but did not significantly ascend into the uterine horns, as determined by epifluorescence microscopy of fluorescently labeled mouse IgG and by immunohistochemical localization of rabbit IgG. Our results suggest that long-term intravaginal delivery of functionally intact antibodies can be achieved with devices composed of EVAc. (+info)
Barriers to contraceptive use in product labeling and practice guidelines.
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Many contraceptives are encumbered with potentially unnecessary restrictions on their use. Indeed, fear of side effects, fostered by alarmist labeling, is a leading reason that women do not use contraceptives. In the United States, hormonal methods currently require a prescription, although research suggests that women can adequately screen themselves for contraindications, manage side effects, and determine an appropriate initiation date, leaving little need for routine direct physician involvement. Sizing, spermicidal use, and length-of-wear limits burden users of cervical barriers and may be unnecessary. Despite recent changes in the labeling of intrauterine devices, clinicians commonly restrict use of this method and in some countries may limit the types of providers authorized to insert them. Although in some cases additional research is necessary, existing data indicate that evidence-based demedicalization of contraceptive provision could reduce costs and improve access. (+info)
A prospective trial comparing oocyte donor ovarian response and recipient pregnancy rates between suppression with gonadotrophin-releasing hormone agonist (GnRHa) alone and dual suppression with a contraceptive vaginal ring and GnRH.
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BACKGROUND: Contraceptive treatment before gonadotrophin-releasing hormone agonist administration presents advantages in women with a tendency to hyper-response and simplifies donor-recipient treatment synchronization. This study compares response to gonadotrophin stimulation under hypophyseal suppression in oocyte donors with or without vaginal contraceptive pretreatment. METHODS: One hundred and ninety oocyte donors were recruited in a single centre and prospectively assigned to one of two treatment groups, according to the day of the week menstruation initiated: Group VC-, no prior vaginal contraceptive and Group VC+, prior vaginal contraceptive. RESULTS: VC+ patients presented a significantly higher cancellation rate, lower plasma estradiol levels and fewer follicles >12 mm on the day of hCG, versus the VC- group. Number of oocytes recovered was significantly lower in the VC+ group. All the cases of severe ovarian hyperstimulation syndrome (SOHSS) were in the VC- group. Pregnancy rates by embryo transfer to synchronic recipients were similar between VC+ and VC- (59.5 versus 57.9%, respectively). CONCLUSIONS: Vaginal contraceptive pretreatment resulted in a higher ovarian suppression, whereas SOHSS rate was lower than in donors who did not receive pretreatment. There were no differences in pregnancy rates between the two groups of synchronic oocyte recipients. (+info)
The rhythm method and embryonic death.
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Some proponents of the pro-life movement argue against morning after pills, IUDs, and contraceptive pills on grounds of a concern for causing embryonic death. What has gone unnoticed, however, is that the pro-life line of argumentation can be extended to the rhythm method of contraception as well. Given certain plausible empirical assumptions, the rhythm method may well be responsible for a much higher number of embryonic deaths than some other contraceptive techniques. (+info)