CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 157 enrolled
Drug / intervention
SCE-B +1 moredrug
Likely dose
SCE-B 0.3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00592839
NCT00592839Phase 4Completed
CompareCT.gov

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

Duramed Research·interventional·Posted Jan 14, 2008·Updated Jul 19, 2013

In Brief

A Phase 4 clinical trial evaluating SCE-B and Placebo for Nocturnal Vasomotor Symptoms. Completed, enrolled 157 participants across 17 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNocturnal Vasomotor Symptoms
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 14, 2008
Enrollment StartDec 1, 2007
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.5 years ago

Interventions

SCE-Bdrug

0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo

Placebodrug

Matching placebo for 0.3 mg and 0.625 mg tablets