Context: The development of a safe and effective reversible method of male contraception is still an unmet need.
Objective: Evaluation of suppression of spermatogenesis and contraceptive protection by coadministered im injections of progestogen and testosterone.
Design: Prospective multicentre study.
Objective: To estimate contraceptive efficacy, safety, acceptability, and fit of a single-size diaphragm used with contraceptive gel.
Methods: We conducted a multicenter trial in which 450 couples used the single-size diaphragm, 300 randomized to acid-buffering gel and 150 to nonoxynol-9, for at least 190 days and six menstrual cycles. Visits were at enrollment and after menstrual cycles 1, 3, and 6.
Several microbicides, including nonoxynol-9 (N-9) and cellulose sulfate (CS), looked promising during early trials but failed in efficacy trials. We aimed to identify Phase I mucosal safety endpoints that might explain that failure. In a blinded, randomized, parallel trial, 60 healthy premenopausal sexually abstinent women applied Universal HEC placebo, 6% CS or 4% N-9 gel twice daily for 13½ days.
View Article and Find Full Text PDFBackground: A bridging study was performed to compare the safety, dose delivery, and acceptability of a prefilled plastic and user-filled paper applicator to assess whether a low-cost, user-filled, paper applicator could serve as a delivery option for tenofovir (TFV) 1% vaginal microbicide gel.
Methods: The study used a randomized crossover design with 25 healthy women randomized to begin with the prefilled or user-filled applicator. Within each study arm, participants delivered two 4.
Interleukins (IL)-8, IL-1α, IL-1β, and IL-1 receptor antagonist (IL-1RA) have emerged as indicators of vaginal inflammation and HIV-1 transmission risk. We provide values and factors of normal variation of these immune mediators in premenopausal women to allow their wider clinical application as biomarkers of vaginal health. Cross-sectional analyzes (Kruskal-Wallis and Wilcoxon exact tests) of cytokine concentrations in relation to sociodemographic variables and Nugent score were performed on baseline (prior to product) cervicovaginal lavage from two Phase I randomized microbicide trials.
View Article and Find Full Text PDFBackground: We report on the functional performance, safety and acceptability of the 90-mm Reddy female condom in two clinical trials, one in Los Angeles, CA, and one in Pune, Maharashtra, India.
Study Design: Both studies used a Phase I, crossover design involving 25 couples. Each couple used three condoms of each of two shaft lengths: in Los Angeles, shaft lengths of 150 and 90 mm were used; in Pune, shaft lengths of 120 and 90 mm were used.
Background: New strategies are needed for preventing HIV infection in women. One potential approach is female-initiated use of an effective topical microbicidal gel in combination with a cervical barrier such as the diaphragm.
Study Design: Randomized, placebo-controlled safety and feasibility trial of diaphragm with vaginal gel during 6 months of use among 120 HIV-negative sexually active women in Johannesburg, South Africa.
Background: Only one female condom [FC1 Female Condom (FC1)] is currently marketed, but it is poorly utilized, perhaps due to difficulty with insertion, discomfort and suboptimal functional performance during intercourse. The Program for Appropriate Technology in Health (PATH) Woman's Condom (WC) was developed in an effort to overcome these obstacles.
Study Design: This was a randomized crossover study to evaluate the functional performance, safety and acceptability of the FC1 and WC.
J Acquir Immune Defic Syndr
November 2008
Objectives: Nigerian women reportedly apply lime juice intravaginally to protect themselves against HIV. In vitro data suggest that lime juice is virucidal, but only at cytotoxic concentrations. This is the first controlled, randomized safety trial of lime juice applied to the human vagina.
View Article and Find Full Text PDFObjective: We assessed colposcopically observed vascular changes occurring in the cervix in relation to cyclical hormonal variation in healthy women.
Materials And Methods: Thirty women with regular menstrual cycles and willing to remain sexually abstinent during a menstrual cycle were enrolled. Colposcopy was performed during the peak of the estrogen and progesterone levels.
Background: This study was conducted to compare the effectiveness of a new, single-size silicone contraceptive diaphragm used with either spermicide [2% nonoxynol-9 (N-9)] or lubricant in preventing sperm from penetrating midcycle cervical mucus.
Study Design: A crossover postcoital test (PCT) in healthy, sexually active women not at risk for pregnancy due to tubal occlusion was conducted. Couples had a baseline PCT without a device to verify normal fertility parameters.
Goal: This study evaluated the effect of a single dose and 5 additional consecutive daily doses of UC781 gel at concentrations of 0.1%, 0.25%, 1.
View Article and Find Full Text PDFObjective: To estimate the 6-month cumulative probability of pregnancy, short-term adverse effects, and acceptability of cellulose sulfate vaginal contraceptive gel.
Methods: Two hundred fertile heterosexual couples were enrolled in this single-center, phase II, 6-month noncomparative study conducted at the California Family Health Council in Los Angeles, California. Couples did not desire pregnancy, were at low risk for sexually transmitted diseases, and agreed to use 3.
Background: The purpose of this study was to assess the functional performance of the BufferGel Duet, a buffering microbicide and spermicide gel applied to the cervix and vagina by a novel applicator that also serves as a mechanical barrier.
Study Design: This was a noncomparative Phase I safety trial in 30 healthy couples, aged 20-50 years, at low risk for sexually transmitted infections, who agreed to use the gel-device combination twice in 1 week and respond to detailed questionnaires about their experience. The female participants were examined with colposcopy before and 6-18 h after using the second device.
Definitions of male condom failure modes are now well documented, and failure events are usually reported as the proportion of the total number of condoms used and the proportion of men/couples who experience an event. The lack of standardized definitions for female condom (FC) failure has led to variability in reporting and hence difficulties in making comparisons across studies. As a result, the World Health Organization convened a technical review committee meeting in January 2006 through which the members compiled and agreed to a standard list of terms and definitions for each of the failure modes.
View Article and Find Full Text PDFObjective: This study evaluated the effect of the so-called universal placebo compared to the polystyrene sulfonate (PSS) placebo on genital irritation.
Design: A single-center, Phase I, randomized, closed-label study was performed to evaluate the genital irritation of microbicide placebo gels. Thirty healthy, sexually abstinent women were randomly assigned to apply 3.
Background: Topical microbicides against the human immunodeficiency virus (HIV) 1 that are nonirritating to the female genital epithelium are urgently needed to slow the heterosexual spread of HIV infection. Products that are also effective contraceptives provide additional benefits. Cellulose sulfate (CS) is a noncytotoxic antifertility agent that exhibits in vitro antimicrobial activity against sexually transmitted pathogens, including HIV.
View Article and Find Full Text PDFAim: To compare the effectiveness of an acid-buffering formulation gel (ACIDFORM) with metronidazole gel in the treatment of symptomatic bacterial vaginosis (BV).
Methods: After a confirmed diagnosis of BV according to the criteria established by Nugent and Amsel, 30 nonpregnant women were enrolled in a randomized, double-blind clinical study. The women were randomly assigned to receive either 5 g ACIDFORM gel (n = 13) or 10% metronidazole gel (n = 17) intravaginally once daily for five consecutive days.
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.
View Article and Find Full Text PDFBackground: An expanded Phase I trial was performed to assess the safety and acceptability of 6% cellulose sulfate gel (CS) in comparison with K-Y Jelly.
Methods: Sexually abstinent (cohort I) and sexually active (cohort II) women in India, Nigeria and Uganda applied 3.5 ml of either 6% CS gel or K-Y Jelly for seven consecutive days.
Objective: Affordable, acceptable and effective female controlled options are required worldwide for prevention of human immunodeficiency virus (HIV) infection and other sexually transmitted diseases. We carried out a comparative acceptability study of Reality and Reddy (version 4) female condoms.
Methods: Sixty eligible couples were enrolled and randomly assigned to use either Reality or Reddy condom first.
Objectives: The aims of this study were to assess the effects of Lea's Shield(R) plus nonoxynol-9 spermicide on signs and symptoms of female genital irritation and cervical and vaginal microflora during 8 weeks of use with intercourse and to analyze problems associated with the use of the device.
Methods: In this open-label, single-arm study, participants were evaluated by pelvic examination, colposcopy and vaginal and cervical cultures.
Results: About 13% of women (4/30) reported symptoms of irritation, and minor product-related colposcopic findings were seen in about one third (11/30).
Background: ACIDFORM gel is being studied as a vaginal contraceptive and microbicide. This study was conducted to make certain that males will not be subjected to an unacceptable risk of penile irritation as a result of exposure to the product in future studies.
Methods: This was a randomized, double-masked, single-center Phase I study in circumcised and uncircumcised men to assess penile irritation, safety and acceptability of seven consecutive doses of ACIDFORM gel compared with K-Y Jelly Personal Lubricant.
Background: Colposcopy is used to evaluate effects of new vaginal products on cervicovaginal epithelium as part of the US Food and Drug Administration-mandated product approval process, yet few aspects of its use have been investigated.
Objectives: To determine the effect of the colposcopic examination itself on the number and type of findings seen, to compare colposcopy with the AviScope hand-held device and the naked eye and to compare the findings reported by two examiners during a single visit.
Study Design: Fourteen healthy women volunteered for five paired examinations in random order: (1) naked eye inspection plus colposcopy done twice by a single examiner; (2) naked eye inspection plus AviScope examination, then naked eye inspection plus colposcopy by a single examiner; (3) Examination 2 repeated with the order of device reversed; (4) naked eye inspection plus colposcopy done by two examiners; (5) Examination 4 repeated with the order of examiner reversed.
Background: C31G is an antimicrobial and spermicidal agent that contains two surface-active compounds, cetyl betaine and myristamine oxide. It is being developed as a vaginal microbicide and contraceptive.
Method: Three C31G concentrations (0.