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At least 343 records · Page 19Linked to original sources
PubMed2001

Tests of Buffergel for contraception and prevention of sexually transmitted diseases in animal models.

BACKGROUND: BufferGel is a novel spermicidal and microbicidal gel formulated to maintain the natural protective acidity of the vagina by acidifying semen, which otherwise alkalinizes the vagina. GOAL: To test the efficacy of BufferGel for preventing sexually transmitted infections and pregnancy in animal models. STUDY DESIGN: Animals were challenged with pathogens or sperm after pretreatment with both test and control agents, or after no pretreatment, then evaluated for infection or pregnancy using standard methods. RESULTS: BufferGel provided significant contraceptive efficacy in the rabbit, and significant protection against vaginal and rectal transmission of herpes simplex virus type 2 (HSV-2) in the mouse, vaginal transmission of Chlamydia trachomatis in the mouse, and skin transmission of cottontail rabbit papillomavirus in the rabbit. It did not protect against vaginal transmission of Neisseria gonorrhoeae in the mouse. CONCLUSIONS: The protective efficacy of BufferGel in five of the six animal models suggests that this microbicide warrants clinical evaluation for both contraception and disease prevention.

Acrylic Resins↗
PubMedDate not supplied

Influence of raloxifene on the efficacy of an estradiol-releasing ring for treating vaginal atrophy in postmenopausal women.

OBJECTIVE: To determine the potential interaction of oral raloxifene 60 mg/day on the efficacy of a low-dose, estradiol-releasing vaginal ring used to treat signs and symptoms of vaginal atrophy in postmenopausal women. DESIGN: Randomized, double-blind, placebo-controlled, parallel treatment trial of raloxifene and placebo with open-label 17beta-estradiol ring. At 10 sites in the United States, 91 postmenopausal women with at least two signs of vaginal atrophy were treated with a 17beta-estradiol ring and randomized to receive concomitant raloxifene 60 mg/day or placebo for 6 months. Efficacy of treatments was evaluated by comparing investigator assessments of genitourinary atrophic signs, vaginal maturation value, and participant assessments of vaginal symptoms at 6 months. Other measures included rate and severity of hot flashes and assessment of sexual function. Uterine safety was assessed by endometrial biopsy and transvaginal ultrasound. RESULTS: In women treated with a 17beta-estradiol ring, both the raloxifene and placebo treatment groups showed improvements in signs and symptoms of vaginal atrophy at 6 months, with no significant differences in degree of improvement between groups. There were no signs of endometrial proliferation in either group. CONCLUSIONS: Concomitant administration of raloxifene does not alter the effects of the 17beta-estradiol ring on alleviating signs and symptoms of genitourinary atrophy in postmenopausal women.

Administration, Intravaginal↗
PubMed2004

Oral, rectal, and vaginal pharmacokinetics of misoprostol.

OBJECTIVE: To compare the pharmacokinetic profiles of orally, rectally, and vaginally administered misoprostol tablets in pregnant women. METHODS: Women between 7 and 14 completed weeks of gestation were recruited and randomly assigned to be given 400 microg misoprostol orally, rectally, or vaginally 3 hours before surgical termination of pregnancy. Blood samples were obtained at 0, 7.5, 15, 30, 45, 60, 90, 120, and 240 minutes and later analyzed for plasma concentrations of misoprostol free acid (the principle metabolite). RESULTS: Vaginal misoprostol was present in the circulation longer than oral misoprostol and had a greater area under curve at 240 minutes (P <.001). Rectal misoprostol had a similar pattern but a much lower area under curve at 240 minutes. Oral misoprostol had a significantly greater peak plasma concentration and a shorter duration to maximum concentration than either rectal or vaginal misoprostol (both P <.001). CONCLUSION: Oral misoprostol tablet is also absorbed by the rectal and vaginal routes. Misoprostol administered in early pregnancy has route-dependent pharmacokinetics and is absorbed best when administered vaginally. LEVEL OF EVIDENCE: I

Administration, Intravaginal↗
PubMed2006

Misoprostol administered by epithelial routes: Drug absorption and uterine response.

OBJECTIVE: To quantify and compare serum levels and uterine effects following vaginal (dry), vaginal (moistened), buccal, and rectal misoprostol administration. METHODS: Forty women seeking elective abortion between 6 and 12 6/7 weeks were randomly assigned to receive 400 mug of misoprostol by one of four routes. A 2.5-mm pressure monitoring catheter was placed through the cervix to the uterine fundus to record uterine tone and activity during the 5-hour observation period. Serum levels of misoprostol acid were measured at 15 and 30 minutes, then every 30 minutes. RESULTS: The four groups were similar in age, race or ethnicity, body mass index, parity, and gestation. Serum levels after vaginal, vaginal moistened and buccal administration rose gradually, peaked between 15 and 120 minutes and fell slowly. Vaginal and vaginal moistened routes produced higher peak serum levels than buccal and rectal (445.9 and 427.1 compared with 264.8 and 202.2 pg/mL; P = .03) and higher serum concentration area under the curve at 5 hours (1,025.0 and 1279.4 compared with 519.6 and 312.5 pg-hr/mL; P < .001). Uterine tone and activity, however, were similar for buccal and the two vaginal routes. After rectal administration, serum levels peaked earlier (P < .001) then dropped more abruptly, and peak uterine tone (P < .001) and total activity (P = .04) were lower than after the other routes. CONCLUSION: Although serum levels were lower for buccal compared with the vaginal routes, the three routes produced similar uterine tone and activity. Rectal administration produced lower uterine tone and activity. Vaginal serum levels were two to three and a half times higher than those observed in prior misoprostol pharmacokinetic studies.

Abortifacient Agents, Nonsteroidal↗
PubMed2006

Breast cancer risk in postmenopausal women using estrogen-only therapy.

OBJECTIVE: To evaluate whether the risk of estrogen-only therapy on breast cancer varies by dose, constituent, and route of administration. METHODS: All Finnish women older than age 50 years using oral or transdermal estradiol (n=84,729), oral estriol (n=7,941), or vaginal estrogens (n=18,314) for at least 6 months during 1994-2001 were identified from the national medical reimbursement register. They were followed for breast cancer with the aid of the Finnish Cancer Registry to the end of 2002. RESULTS: Altogether, 2,171 women with breast cancer were identified. The standardized incidence ratio of breast cancer with systemic estradiol for less than 5 years was 0.93 (95% confidence interval 0.80-1.04), and for estradiol use for 5 years or more, 1.44 (1.29-1.59). Oral and transdermal estradiol was accompanied by a similar risk of breast cancer. The risk was most prominent with the dose greater than 1.9 mg/d orally; whereas the risk associated with transdermal route was not dose-dependent. The standardized incidence ratio for the lobular type of breast cancer (1.58) was slightly higher than that for the ductal type (1.36). The use of estradiol was associated with both localized breast cancer (1.45; 1.26-1.66) and cancer spread to regional nodes (1.35; 1.09-1.65). The incidence of carcinoma in situ (n=32) was increased (2.43; 1.66-3.42) among estradiol users. CONCLUSION: Estradiol for 5 years or more, either orally or transdermally, means 2-3 extra cases of breast cancer per 1,000 women who are followed for 10 years. Oral estradiol use for less than 5 years, oral estriol, or vaginal estrogens were not associated with a risk of breast cancer. LEVEL OF EVIDENCE: II-2.

Administration, Cutaneous↗
PubMed2004

Safety and efficacy evaluations for vaginal and rectal use of BufferGel in the macaque model.

BACKGROUND: The nonhuman primate model allows for safety and efficacy testing of topical microbicide products. GOAL: The goal of this study was to evaluate the safety and efficacy of vaginal and rectal applications of BufferGel (ReProtect, Inc.). STUDY DESIGN: The safety of repeated product applications was evaluated by microflora, pH, vaginal colposcopy, and rectal lavage. To test efficacy in preventing chlamydia, infection was documented by culture and nucleic acid amplification tests. RESULTS: Repeated vaginal or rectal applications of BufferGel were not associated with significant changes in microflora. BufferGel use had a transient acidifying effect on vaginal and rectal pH. Colposcopic observations remained relatively normal in all test animals. A slightly increased incidence of epithelial desquamation was noted after rectal product use compared with the control group. BufferGel did not prevent cervical or rectal chlamydial infection. CONCLUSION: BufferGel has an acceptable safety profile after repeated vaginal and rectal use, but does not prevent chlamydial infection in the macaque models.

Acrylic Resins↗
PubMed2004

Receptivity for probiotic products among premenopausal female students in an African university.

OBJECTIVE: The objective of this study was to examine the receptivity for probiotic products among premenopausal female students in an African university. GOAL: The goal of this study was to determine the local knowledge in Nigeria of probiotics and the willingness of young women to use them should they be introduced. STUDY: Closed-ended questionnaires were administered to a sample of 280 participants and these addressed age, marital status, perceived risk of HIV infection for the next 3 years, and history of urogenital infections. The participants were also asked whether they would welcome a probiotic product in oral/vaginal form and in milk-based food products, willingness to purchase and use, how often they would use these products, preference of form, price, and where they would like to buy the products. The second questionnaire was open-ended. It asked the participants to freely list any concerns or worries they had in relation to probiotic products. RESULTS: Of the 280 participants, 55.3% indicated that they believed they were at risk of acquiring HIV within the next 3 years, illustrating the enormity of the problem in Africa and the feelings among women that they cannot easily control sexual relationships and have partners use condoms. Eighty-two percent of the subjects stated they would welcome probiotic products in capsular form for vaginal instillation or to be taken orally to improve vaginal health. Over one third (36%) of women indicated they would be willing to use the probiotic products as part of their daily self-care. One hundred nine (39.6%) respondents were willing to purchase the probiotic products at a reasonable price of 0.08 US dollars per dose, whereas 71.5% were willing to pay up to 0.38 US dollars. Some subjects (25%) raised some concern over safety of probiotics. CONCLUSIONS: The findings revealed that female university students are receptive to probiotic products in Nigeria and indicate strongly a need to consider women's concerns about urogenital health. Furthermore, the study identified a need for appropriate educational materials about probiotics, including benefits and safety information, in an African country suffering severely from the HIV epidemic.

Administration, Intravaginal↗
PubMed2005

Mucosal alloimmunization elicits T-cell proliferation, CC chemokines, CCR5 antibodies and inhibition of simian immunodeficiency virus infectivity.

The hypothesis was tested that mucosal stimulation with unmatched mononuclear cells would induce systemic alloimmune responses. Rectal or vaginal mucosal administration of 10(4)-10(7) unmatched mononuclear cells induced significant dose-dependent T-cell proliferation stimulated by the allogeneic cells in rhesus macaques. This was associated with a significant upregulation of CD8(+) T-cell-derived suppressor factor, as well as the CC chemokines CCL3, CCL4 and CCL5. In addition, there was a dose-dependent increase in antibodies to CCR5. These responses were associated with decreased in vitro simian immunodeficiency virus (SIV) infectivity of CD4(+) T cells. A further investigation of SIV infectivity of CD4(+) T cells separated from multiparous macaques also showed significant inhibition compared with male macaques. It is suggested that vaginal or rectal exposure to allogeneic stimulation by a partner's HLA antigens in seminal fluid, as occurs during sexual intercourse, or immunization by semi-allogeneic fetuses in multiparous females may elicit protection against SIV or human immunodeficiency virus infection.

Administration, Intravaginal↗
PubMedDate not supplied

Cost-reducing protein production and delivery for sexually transmitted disease prevention.

Table 2 summarizes our two approaches: vaginal delivery of antibodies to immunize passively and edible microspheres for active immunization. These approaches have different roles in disease prevention in communities and each may be most useful for different kinds of diseases. The passive approach could easily be extended to lots of different sexually transmitted diseases by just changing the specificity of the antibody incorporated into the device. The active immunization approach requires more specific development steps for each particular type of disease. Detailed analysis of the cost-reduction potential of these approaches is not yet available, but estimates of the cost to manufacture these products can be made, based on the initial laboratory studies (Table 4). The results to date suggest that both products are feasible and that they could be manufactured as cheaply as other products (such as condoms and oral contraceptives) that people currently use for sexual health. All products, once made available, could have a significant impact on the reduction of healthcare costs.

Administration, Intravaginal↗
PubMed2005

Effect of antiprogesterone mifepristone followed by misoprostol on circulating leptin in early pregnancy.

BACKGROUND: To study the role of progesterone (P4) in the regulation of circulating leptin in early human pregnancy, we measured the levels of leptin before and after administration of the antiprogestin mifepristone, followed by misoprostol in early pregnancy. METHODS: Thirty-four women requesting termination of pregnancy, with < or =63 days of amenorrhea, received 200 mg of mifepristone on day 0, followed by either oral or vaginal administration of 0.8 mg of misoprostol on day 2. Five serial serum samples were assayed for leptin, human chorionic gonadotrophin (hCG), P4, estradiol (E2), cortisol, and mifepristone. RESULTS: Circulating leptin concentrations decreased by 8.7 +/- 29.7% (mean +/- standard deviation) (p < 0.05) following the ingestion of mifepristone. After misoprostol administration on day 2, a decrease of 12.6 +/- 17.0% (p < 0.05) was followed by a rebound on day 3 to 87.6 +/- 25.7% of the pretreatment values. Two weeks after mifepristone, leptin levels had declined by 25.4 +/- 30.4%. In contrast, E2, P4, and hCG concentrations continued to increase following mifepristone, followed by rapid declines from day 2 to day 3. Serum cortisol concentrations increased by 89.7% +/- 82.7% in response to mifepristone, but this increase did not correlate with the decrease in leptin. The decrease in leptin levels on day 2 correlated with the decreases in P4 (r = 0.37, p < 0.05) and in E2 (r = 0.44, p < 0.05) levels. CONCLUSIONS: The fall in leptin levels following mifepristone implies a role for P4 in the regulation of leptin in early pregnancy. Moreover, the significant correlation between the changes in leptin and those of P4 and E2 at the time of luteolysis suggests that corpus luteum may also play a role in the regulation of circulating leptin in early pregnancy.

Abortifacient Agents, Steroidal↗
PubMed1990

The efficacy and tolerance of mifepristone and prostaglandin in first trimester termination of pregnancy. UK Multicentre Trial.

OBJECTIVE: To investigate the use of oral mifepristone (RU 486) and vaginal gemeprost for the induction of legal first trimester abortion. DESIGN: An uncontrolled multicentre observational study. SETTING: 13 Hospital gynaecological units in Scotland and England. SUBJECTS: 588 Pregnant women with up to nine weeks amenorrhoea having legal abortions. INTERVENTIONS: Oral mifepristone 600 mg followed 48 h later by vaginal gemeprost 1 mg. Women stayed in the hospital for a minimum of 4 h on each occasion. MAIN OUTCOME MEASURES: Frequency of complete abortion and the need for subsequent surgical evacuation, analgesia and blood transfusion. RESULTS: There was complete abortion in 94% (95% CI 92-96%). None of the 46 women at less than 43 days gestation needed surgical evacuation. This was performed in 6.5% of the remainder but among these the rate did not increase with gestation. Five women (four from one centre) required both curettage and blood transfusion. A fall in haemoglobin concentration of 2-4 g/dl occurred in only 1%. Narcotic analgesia was required after gemeprost by 37% of nullipara and 13% of multipara. Overall 26% had vomiting and 13% diarrhoea. CONCLUSION: The sequential use of oral mifepristone and vaginal gemeprost is effective in inducing abortion up to the 63rd day of pregnancy. Efficient management of pain and bleeding is easier if women are in a hospital for some hours after the gemeprost.

Abortifacient Agents↗
PubMed1990

Experience with a 'physiological' steroid replacement regimen for the establishment of a receptive endometrium in women with premature ovarian failure.

Eighteen women with a premature menopause underwent assessment of serial serum oestradiol (E2) and progesterone levels and endometrial histology and function. Patients received continuous transdermal E2, and progesterone either orally or vaginally for 14 days. Physiological levels of E2 were attained. Significantly higher levels of progesterone were achieved with vaginal progesterone (P less than 0.01). Endometrial biopsies obtained during E2 replacement demonstrated normal proliferative features. Expression of an oestrogen related antigen (ER-Ag) was localized in the cytoplasm of the epithelium. After 3 days of progesterone replacement the endometrium showed normal secretory features and expression of ER-Ag in the stroma as well as in the glands. After 7 days of progesterone supplementation, vaginal administration produced a more consistent physiological appearance than oral administration. Thus transdermal E2 combined with vaginal progesterone is a highly satisfactory combination for establishing a physiological endometrium in women with premature ovarian failure.

Administration, Intravaginal↗
PubMed1996

A randomised comparison of oral and vaginal misoprostol for cervical priming before suction termination of pregnancy.

OBJECTIVE: To assess the effectiveness and acceptability of oral misoprostol, self-administered 12 h before surgery, as a cervical priming agent prior to day case suction termination of pregnancy. DESIGN: Randomised trial comparing oral misoprostol with the local standard regimen of vaginal misoprostol. SUBJECTS: Sixty consecutive women scheduled for day case suction termination in one gynaecology unit. INTERVENTIONS: Cervical priming with misoprostol 400 mg orally, 12 h prior to surgery or 800 mg vaginally, two to four hours prior to surgery. MAIN OUTCOME MEASURES: Basal cervical dilatation, cumulative force required to dilate the cervix to 9 mm, operative blood loss and side effects (nausea, vomiting, diarrhoea, abdominal pain and vaginal bleeding). RESULTS: There were no significant differences between the oral and vaginal treatment groups in relation to basal dilatation, cumulative force to achieve 9 mm dilatation or gastrointestinal side effects. However, those in the oral group experienced more severe pain and heavier pre-operative bleeding. Two patients in the oral group experienced incomplete abortion at home after taking misoprostol and a further patient required early admission because of heavy bleeding. CONCLUSIONS: Because of the unpredictability of action of oral misoprostol, with incomplete abortion or heavy bleeding occurring prior to admission in three patients, we cannot recommend the dosage schedule evaluated here for routine clinical use.

Abortifacient Agents, Nonsteroidal↗
PubMed1997

Newer HRT regimens.

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Administration, Cutaneous↗