Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women

Summary

This is a multi-center study to evaluate the effects of SCE-B on nocturnal vasomotor symptoms. Study duration will be approximately 16 weeks; this includes a 4-week screening period and approximately 5 scheduled clinic visits. Participants will receive one of two strengths of SCE-B tablets plus matching placebo or placebo only, and will have a physical and gynecological exams that may include transvaginal ultrasound, endometrial biopsy and a pap smear. Participants will be asked to wear a monitoring device for a portion of the study and be asked to complete a daily dairy.

Timeline

Start

2007-12

Primary completion

2009-02

Completion

2009-02

Outcome

Met primary endpoint

paper Significantly greater reductions from baseline in the weekly mean frequency of awakenings resulting from hot flushes occurred PMID 22183214 ↗

paper participants randomized to either synthetic conjugated estrogens-B dose relative to placebo (mean reductions, 3.55, P=.004, and 4.65, P<.001 PMID 22183214 ↗

Publications

• Liu JH, Reape KZ, Hait HI. Synthetic conjugated estrogens-B and postmenopausal nocturnal vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):78-84. doi: 10.1097/AOG.0b013e31823c0145.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SCE-B	Unknown	0.3 mg	Oral
Subject	SCE-B	Unknown	0.625 mg	Oral

Indications

No indication recorded.