NCT00592839

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

A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of SCE-B on Nocturnal Vasomotor Symptoms in Postmenopausal Women

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Duramed Research · Industry
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nocturnal Vasomotor Symptoms

Interventions

Type	Name	Description
DRUG	SCE-B	0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo
DRUG	Placebo	Matching placebo for 0.3 mg and 0.625 mg tablets

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-01-14
• Last updated: 2013-07-19
• Results posted: 2010-03-17

Locations

17 sites across 1 country: United States