OBJECTIVE To demonstrate the comparative efficacy and tolerability of capsules containing 200 mg of P (Utrogest 200) or Crinone 8% gel for luteal phase and early pregnancy support during assisted reproduction techniques (ART). DESIGN Prospective, multicenter, randomized, controlled, open, parallel-group Phase III trial. SETTING Seventeen German IVF centers. PATIENT(S) Four hundred thirty ...

We previously reported nonaqueous silicone elastomer gels (SEGs) for sustained vaginal administration of the CCR5-targeted entry inhibitor maraviroc (MVC). Here, we describe chemically modified SEGs (h-SEGs) in which the hydrophobic cyclomethicone component was partially replaced with relatively hydrophilic silanol-terminated polydimethylsiloxanes (st-PDMS). MVC and emtricitabine (a nucleoside ...

Topical administration of clotrimazole represents the common use therapy in the antimycotic genitourinary tract treatment. Due to the fast self-cleaning action of the vagina, commercially available vaginal dosage forms with clotrimazole cannot assure prolonged contact time with mucosa, therefore the main objective of this study was to develop a dosage form for vaginal administration of clotrima...

A 7.4% vaginal extract of the Brazilian pepper tree (Schinus terebinthifolius Raddi) was compared with 0.75% vaginal metronidazole, both manufactured by the Hebron Laboratory, for the treatment of bacterial vaginosis, used at bedtime for 7 nights. The condition was diagnosed using the combined criteria of Amsel and Nugent in two groups of 140 and 137 women, aged between 18 and 40 years. Intenti...

OBJECTIVE Diaphragms are being considered for use with vaginal microbicide gels to provide enhanced protection against sexually transmitted pathogens. The purpose of this study was to determine whether use of a diaphragm with microbicide or placebo gel causes cervicovaginal inflammation or perturbations in cervicovaginal immune defense. METHOD OF STUDY Eighty-one non-pregnant women were rando...

Introduction: During 2004-15, nine randomized controlled trials (RCT) for HIV prevention tested pre-exposure prophylaxis (PrEP) with oral drugs, vaginal gels, or vaginal rings among more than 17,000 women in Africa. Methods: This study uses information from the nine RCTs to estimate the proportions of HIV from sexual and bloodborne risks, to consider reasons for success or failure with oral PrE...

Objectives: A pilot efficacy and tolerability trial of suppressive metronidazole vaginal gel in reducing recurrent symptomatic relapses of bacterial vaginosis (BV). Study design: A prospective open labeled study. Women with recurrent BV were assigned to metronidazole gel 3 times monthly for 24 weeks. The mean episodes of relapses of recurrence of BV after metronidazole suppression was compared ...

OBJECTIVE To compare progesterone concentrations in serum and endometrial tissue from hysterectomy specimens after vaginal or intramuscular (IM) administration of progesterone gel. METHODS This was a randomized open study of 14 post-menopausal women undergoing transabdominal hysterectomies. Participants received either vaginal progesterone gel, 90 mg, or IM progesterone, 50 mg, at 8:00 AM and...

Antiretroviral entry inhibitors are now being considered as vaginally administered microbicide candidates for the prevention of the sexual transmission of human immunodeficiency virus. Previous studies testing the entry inhibitors maraviroc and CMPD167 in aqueous gel formulations showed efficacy in the macaque challenge model, although protection was highly dependent on the time period between ...