A randomized crossover study to evaluate local tolerability following subcutaneous administration of a new depot medroxyprogesterone acetate contraceptive formulation.

Objectives: This study aimed to evaluate and compare local tolerability of investigational drug TV-46046 and reference drug Depo-subQ Provera 104, both containing medroxyprogesterone acetate (MPA) as an active ingredient.

Study Design: We conducted a randomized, crossover, single-center study. Twenty-seven healthy women aged 25 to 47 years at low risk of pregnancy received a subcutaneous injection of each of the four study drugs (120 mg/0.

Assessment of the vaginal residence time of biomarkers of semen exposure.

Objective: The primary objective of this pilot study is to determine and compare the residence time in the vagina of biomarkers of semen exposure for up to 15 days post exposure. The biomarkers are prostate-specific antigen (PSA), Y chromosome DNA, the sex determining region of the Y chromosome (SRY) and testis-specific protein Y-encoded 4 (TSPY4). The secondary objectives are to determine if biomarker concentrations differed between intercourse and inoculation groups, to establish whether the sampling frequency post exposure affected biomarker concentrations and decay profile and to determine if biomarker concentrations in vaginal swabs obtained by the participant at home were similar to swabs obtained by the nurse in the clinic.

Effectiveness, safety and acceptability of Sino-implant (II) during the first year of use: results from Kenya and Pakistan.

Background: Sino-implant (II) is a two-rod subcutaneous contraceptive implant used up to 4 years, containing 150 mg of levonorgestrel. We conducted two observational studies of Sino-implant (II) to evaluate its performance in routine service delivery settings.

Methods: We enrolled 1326 women age 18-44 who had Sino-implant (II) inserted at clinics in Pakistan and Kenya.

A single-arm study to evaluate the efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel.

Background: An oral dose of 0.75 mg levonorgestrel (LNG) taken shortly after sex was marketed as a routine, nonemergency contraceptive method until the 1990s. Because a hormonal method used only at the time of intercourse may be desirable for women who have infrequent sex, we conducted a study to reevaluate the potential of pericoital LNG as a primary means of contraception.

Performance of Sino-implant (II) in routine service delivery in Madagascar.

Background: Sino-implant (II) is a low-cost subdermal contraceptive implant containing levonorgestrel that is currently labeled for 4 years of use. Widely used in China and Indonesia, it has been little studied elsewhere. We conducted a prospective study of Sino-implant (II) use by women in Madagascar.

Pelvic surgery and hospitalization among Chilean women after nonsurgical sterilization with quinacrine pellets between 1977 and 1989.

Background: Concern about quinacrine lingers because of its carcinogenic effects in rats. We describe results of long-term follow-up of women who underwent quinacrine pellet sterilization in Chile between 1977 and 1989 (N=1492).

Methods: We interviewed the women or relatives in five rounds of data collection between 1991-1993 and 2006-2007, and reviewed hospital records.

Cancer risk after sterilization with transcervical quinacrine: updated findings from a Chilean cohort.

Background: Dating back to the 1970s, thousands of women worldwide have voluntarily been sterilized with transcervical insertion of quinacrine pellets. The safety and efficacy of the technology are still being assessed today; in particular, better estimates on the incidence of human cancers are now feasible.

Methods: We conducted a cohort study of 1492 women in Santiago and Valdivia, Chile, who received transcervical quinacrine pellets for contraceptive sterilization between 1977 and 1989.

Safety evaluation of 1% tenofovir gel in healthy men.

This study was conducted to determine the safety of tenofovir (TFV) gel, a potential microbicide, following seven consecutive daily penile applications. Eighteen circumcised and 18 uncircumcised healthy men were randomly assigned to TFV gel versus K-Y Jelly in a 2:1 ratio within circumcision group. TFV gel or K-Y Jelly was applied onto the penis at bedtime and washed off 6-10 hours later.

Comparative crossover study of the PATH Woman's Condom and the FC Female Condom.

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.

A Phase I study of the functional performance, safety and acceptability of the BufferGel Duet.

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.

Retrospective vs. prospective coital frequency and menstrual cycle length in a contraceptive effectiveness trial.

Purpose: To determine how well information at enrollment would predict coital frequency and menstrual segment length during a prospective contraceptive effectiveness trial.

Methods: We compared retrospective reports of monthly coital frequency and menstrual segment (cycle) length with prospective information for women participating in a contraceptive trial of the Reality((R)) female condom.

Results: Participants reported slightly higher mean monthly coital frequency and slightly longer menstrual segments prior to the study than during the study (12.

How well do male latex condoms work? Pregnancy outcome during one menstrual cycle of use.

To evaluate the contraceptive effectiveness of male latex condoms, we assembled a cohort of 300 women relying on male latex condoms for contraception and followed them prospectively for one menstrual cycle. None of the 234 women who completed the study and reported at least one act of intercourse conceived (one cycle pregnancy rate 0%; 95% CI 0%--2%). Given the pattern of intercourse during the cycle and 3 different sets of conception probabilities for different days of the cycle, we would have expected between 32 and 36 pregnancies if no condoms had been used.

Influence of cycle variability and coital frequency on the risk of pregnancy.

Researchers have cautioned against generalizing results from contraceptive trials because these studies rely on self-selected participants meeting strict selection criteria who may differ from typical users. Using information collected on daily diaries, we reanalyzed data from the recently completed Reality female condom clinical trial to evaluate factors that influence the probability of pregnancy. Noncompliant women, women with less variable menstrual cycles (17-43 days), and women engaging in intercourse frequently (> or = 11 acts per month) were more likely to conceive during this 6-month trial.