Impact of age, race, and medication use on efficacy endpoints in a randomized controlled trial of topical sildenafil cream for the treatment of female sexual arousal disorder.

Background: A study of topical Sildenafil Cream 3.6% was completed among healthy premenopausal women with female sexual arousal disorder.

Aims: To compare efficacy endpoints based on product use in pre-planned and post-hoc subsets of age, race, and medication use.

Preliminary Efficacy of Topical Sildenafil Cream for the Treatment of Female Sexual Arousal Disorder: A Randomized Controlled Trial.

Objective: To assess the efficacy of topical sildenafil cream, 3.6% among healthy premenopausal women with female sexual arousal disorder.

Methods: We conducted a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream.

Vaginal microbiota and mucosal pharmacokinetics of tenofovir in healthy women using tenofovir and tenofovir/levonorgestrel vaginal rings.

Recent data support that the vaginal microbiota may alter mucosal pharmacokinetics (PK) of topically delivered microbicides. Our team developed an intravaginal ring (IVR) that delivers tenofovir (TFV) (8-10 mg/day) alone or with levonorgestrel (LNG) (20 ug/day). We evaluated the effect of IVRs on the vaginal microbiota, and describe how the vaginal microbiota impacts mucosal PK of TFV.

Randomized, placebo controlled phase I trial of safety, pharmacokinetics, pharmacodynamics and acceptability of tenofovir and tenofovir plus levonorgestrel vaginal rings in women.

To prevent the global health burdens of human immunodeficiency virus [HIV] and unintended/mistimed pregnancies, we developed an intravaginal ring [IVR] that delivers tenofovir [TFV] at ~10mg/day alone or with levonorgestrel [LNG] at ~20μg/day for 90 days. We present safety, pharmacokinetics, pharmacodynamics, acceptability and drug release data in healthy women. CONRAD A13-128 was a randomized, placebo controlled phase I study.

Differences in Local and Systemic TFV PK Among Premenopausal Versus Postmenopausal Women Exposed to TFV 1% Vaginal Gel.

Objective: We describe and compare the local and systemic pharmacokinetics (PK) of tenofovir (TFV) and TFV-diphosphate (TFV-DP) in healthy premenopausal (PRE) and postmenopausal (POST) women using TFV 1% gel and correlate local PK with other mucosal end points.

Methods: PRE (n = 20) and POST (n = 17) women used 2 doses of TFV 1% vaginal gel, separated by 2 hours. Blood and cervicovaginal samples were obtained 3 and 23 hours after the second dose.

Comparison of Mucosal Markers of Human Immunodeficiency Virus Susceptibility in Healthy Premenopausal Versus Postmenopausal Women.

The objective of this study was to characterize cervicovaginal (CV) mucosal factors modulating susceptibility to human immunodeficiency virus (HIV) acquisition in healthy premenopausal (PRE) and postmenopausal (POST) women before and after treatment with estradiol (E2). We compared CV mucosal epithelial histology and immune cells, vaginal microbiota, antimicrobial activity of and soluble mucosal protein concentrations in the CV fluid lavage (CVL), and p24 antigen production after ex vivo infection of ectocervical tissues with HIV-1 among PRE women (n = 20) in the follicular and luteal phases of the menstrual cycle and POST women (n = 17) at baseline and after ∼1 month of treatment with 0.01% vaginal E2 cream.

Analytical Advances in the Ex Vivo Challenge Efficacy Assay.

The ex vivo challenge assay is being increasingly used as an efficacy endpoint during early human clinical trials of HIV prevention treatments. There is no standard methodology for the ex vivo challenge assay, although the use of different data collection methods and analytical parameters may impact results and reduce the comparability of findings between trials. In this analysis, we describe the impact of data imputation methods, kit type, testing schedule and tissue type on variability, statistical power, and ex vivo HIV growth kinetics.

Comparison of visual and ultraviolet light inspection versus DNA/protein biomarkers to assess product adherence with vaginal microbicide applicators.

Background: Objective biomarkers of product use and protocol compliance are urgently needed. We compared the sensitivity and specificity of DNA and protein-based biomarkers, obtained from used vaginal gel applicators, to visual inspection of those applicators under ambient light (visual inspection of returned applicator [VIRA]) and ultraviolet light (UVL).

Methods: Forty women inserted hydroxyethylcellulose placebo gel vaginal applicators under direct observation.

Intravaginal rings as delivery systems for microbicides and multipurpose prevention technologies.

There is a renewed interest in delivering pharmaceutical products via intravaginal rings (IVRs). IVRs are flexible torus-shaped drug delivery systems that can be easily inserted and removed by the woman and that provide both sustained and controlled drug release, lasting for several weeks to several months. In terms of women's health care products, it has been established that IVRs effectively deliver contraceptive steroids and steroids for the treatment of postmenopausal vaginal atrophy.

Depot medroxyprogesterone acetate increases immune cell numbers and activation markers in human vaginal mucosal tissues.

The relationship between exogenous contraceptive hormones and permissiveness of the female genital tract to human immunodeficiency virus type 1 (HIV-1) is the subject of renewed debate. To better characterize the effect of depot medroxyprogesterone acetate (DMPA) on HIV-1 cellular targets and epithelial integrity in the vagina, we compared leukocyte populations, markers of activation and proliferation, and the density of intercellular junctional proteins in the vaginal epithelium of women during the follicular and luteal phases of the menstrual cycle and approximately 12 weeks after receiving a DMPA injection. This prospective cohort study involved 15 healthy women.

Multipurpose prevention technologies: biomedical tools to prevent HIV-1, HSV-2, and unintended pregnancies.

Statistics clearly show an unmet need for highly effective contraception, especially in less developed countries. Many of these countries are at the core of the HIV/AIDS epidemic and show very high prevalence rates for other sexually transmitted infections (STIs) such as that caused by HSV-2. A woman at risk of unintended pregnancy due to unprotected intercourse is also at risk for HIV/STI.

One-year follow-up of women with unfulfilled postpartum sterilization requests.

Objective: To track outcomes of women in three cohorts-those who requested postpartum tubal ligation and received the procedure (postpartum tubal ligation [PPTL] YES), those who requested postpartum tubal ligation but did not receive the procedure (PPTL NO), and a control group (those who did not request postpartum tubal ligation)-for 1 year postpartum.

Methods: This was a record review evaluating women who delivered a liveborn singleton between December 2007 and May 2008 at the University of Texas San Antonio. Those in the case group were monitored until 1 year postdelivery.

Post-cesarean delivery infectious morbidity: Focus on preoperative antibiotics and methicillin-resistant Staphylococcus aureus.

Background: Randomized controlled trials show that administering preoperative antibiotics prior to cesarean delivery (CD) significantly reduces the incidence of post-CD infectious morbidity. Methicillin-resistant Staphylococcus aureus (MRSA) has become prevalent in obstetrics and gynecology. The objective of this trial is to examine infectious morbidity in a clinical setting before versus after implementation of a preoperative antibiotic policy and, further, to describe the organisms cultured from CD wound infections.

An alternative monitoring protocol for single-dose methotrexate therapy in ectopic pregnancy.

Objective: We sought to determine the sensitivity and specificity of alternative monitoring regimens in predicting the need for a second methotrexate (MTX) dose in women undergoing medical therapy for ectopic pregnancy.

Study Design: We reviewed 187 women who received MTX for ectopic pregnancy.

Results: We defined MTX treatment success as a clinically stable patient whose day-7 beta human chorionic gonadotropin (beta-hCG) level decreased by > or = 50%, compared with the day-of-treatment (DOT) beta-hCG.

Unfulfilled postpartum sterilization requests.

Objective: To determine individual and delivery characteristics of women least likely to obtain a requested postpartum tubal ligation (PPTL) and, secondarily, to compare the postpartum contraceptive choices of women with an unfulfilled sterilization request to women not requesting a PPTL.

Study Design: Record review ofwomen delivering a liveborn singleton between December 2007 and May 2008 at the University of Texas San Antonio. Primary outcomes were risk factors for not receiving a requested PPTL.

The male sexual partners of adult versus teen women with sexually transmitted infections.

Objectives: We compared the male sexual partners of teen girls of age 15 to 19 years, currently infected with a sexually transmitted infection (STI) versus the male partners of adult women of age 20 to 41 years, with an STI to determine risk factors in these high-risk sexual dyads related to the male partner.

Study Design: Interview of 514 men who were partnered with 152 teen girls and 362 adult women, enrolled in Project Sexual Awareness for Everyone, a randomized controlled trial of behavioral intervention to reduce recurrent STIs.

Results: Compared to the male partners of adult women, male partners of teen girls were significantly more likely (P < 0.

Effect of acculturation on the acceptability of potential microbicides and sexual risk-taking.

Background: The objective was to determine the acceptability and use patterns of potential microbicides among African American (AA), acculturated Hispanic (AH), and less acculturated Hispanic (LAH) women. We measured baseline sexual risk-taking and the likelihood of behavioral change, given effective microbicides.

Methods: Interview of 506 Mexican-American and AA women, all of whom have a sexually transmitted infection enrolled in Project Sexual Awareness for Everyone.

Methicillin-resistant Staphylococcus aureus as a common cause of vulvar abscesses.

Objective: To estimate the incidence of methicillin-resistant Staphylococcus aureus (MRSA) among women with vulvar abscesses and to describe clinical factors associated with inpatient compared with outpatient treatment.

Methods: We reviewed all women with a vulvar abscess who were treated with incision and drainage between October 2006 to March 2008. We reviewed the abscess cultures and evaluated clinical and laboratory variables associated with inpatient compared with outpatient treatment.

Preventing recurrent sexually transmitted diseases in minority adolescents: a randomized controlled trial.

Objective: To compare the efficacy of a randomized controlled trial of the Sexual Awareness For Everyone (SAFE) behavioral intervention on teenagers (aged 14 to 18 years) compared with adult rates of reinfection with Neiserria gonorrhea or Chlamydia trachomatis cervicitis, and to identify behaviors associated with recurrent infection.

Methods: Mexican-American and African-American females with a nonviral sexually transmitted disease (STD) were enrolled in SAFE or assigned to the control group. All participants were interviewed and examined at baseline, 6, and 12 months.

Partner notification of sexually transmitted infections among pregnant women.

The object of this study was to determine the factors associated with partner notification (PN) of sexually transmitted infection (STI) exposure among pregnant, low income, Mexican-American (MA) and African-American (AA) women and their male sexual partners. We used a cross-sectional analysis of 166 pregnant women with an STI, enrolled in a randomized controlled trial of behavioural intervention to prevent recurrent STIs. The primary outcome, PN, is notification of, or intent to notify male sexual partner(s) of STI exposure.