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NCT00160173 · ClinicalTrials.gov registry record · Phase 4
Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy
A Phase 4 study of Postmenopausal Symptoms, sponsored by ASCEND Therapeutics.
- Completed
- Registry status
- Phase 4
- Development phase
- 221
- Enrollment target
- 20
- Study locations
NCT00160173: Completed Phase 4 study of Postmenopausal Symptoms, sponsored by ASCEND Therapeutics.
NCT00160173 is a Phase 4 study of Postmenopausal Symptoms that has completed, run by ASCEND Therapeutics. The registered enrollment target is 221 participants, above the 66-participant average among 7 other Postmenopausal Symptoms trials with a reported enrollment target (235% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00160173, a Phase 4 study of Postmenopausal Symptoms, has completed, sponsored by ASCEND Therapeutics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 221 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Estrogel
Study Locations (20)
California
- Site 104 - Carmichael
- Site 42 - Encinitas
- Site 21 - San Diego
- Site 37 - San Diego
- Site 78 - San Diego
- Site 82 - San Diego
Connecticut
- Site 69 - Avon
- Site 58 - Bridgeport
- Site 3 - Groton
- Site 72 - Hartford
- Site 54 - New Britain
- Site 79 - Southport
Alabama
- Site 112 - Birmingham
- Site 74 - Mobile
- Site 20 - Montgomery
Arkansas
- Site 5 - Jonesboro
- Site 88 - Little Rock
- Site 95 - Little Rock
Arizona
- Site 34 - Tucson
- Site 68 - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2004-12-02 |
| Est. Completion | 2005-09-06 |
| Phase | Phase 4 |
What the finished NCT00160173 record still lists
NCT00160173 is an interventional study that assigns participants to a tested intervention. The registered 221 participants enrollment target is mid-sized for trials with a published cap, above the 66-participant average among 7 other Postmenopausal Symptoms trials with a reported enrollment target (235% higher).
The record links to 1 condition, with Postmenopausal Symptoms appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00160173 names 20 study sites across 5 states, led by California, Connecticut, Alabama.
Frequently Asked Questions
What is clinical trial NCT00160173 about?
NCT00160173 is a clinical study titled "Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy". This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.
What is the current status of trial NCT00160173?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 221 participants. The study started on 2004-12-02. Estimated completion is 2005-09-06.
What conditions does trial NCT00160173 study?
This clinical trial studies the following conditions: Postmenopausal Symptoms.
What interventions are being tested in trial NCT00160173?
The interventions under investigation include: Placebo (OTHER), Estrogel (DRUG).
Who is sponsoring clinical trial NCT00160173?
This trial is sponsored by ASCEND Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00160173 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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