CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 126 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
Ospemifene 5 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/NCT00630539
NCT00630539Phase 2Completed
CompareCT.gov

Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A Phase II Dose Ranging, 12-Week, Randomized , Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 5 mg, 15 mg and 30 mg Daily Doses With Placebo

Shionogi·interventional·Posted Mar 7, 2008·Updated Jun 28, 2013

In Brief

A Phase 2 clinical trial evaluating Placebo, Ospemifene 5 mg, and 2 other interventions for Atrophy and Vaginal Diseases. Completed, enrolled 126 participants.

Detailed Summary

The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg tested earlier in Phase II.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrophy, Vaginal Diseases
Countries--
CollaboratorsHormos Medical, QuatRx Pharmaceuticals

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 7, 2008
Enrollment StartAug 1, 2007
Primary CompletionJan 1, 2008
Study CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 18.3 years ago

Interventions

Placebodrug

1 tablet per day, orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Ospemifene 5 mgdrug

1 tablet of ospemifene 5 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Ospemifene 15 mgdrug

1 tablet of ospemifene 15 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Ospemifene 30 mgdrug

1 tablet of ospemifene 30 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).