At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 764 enrolled
Drug / intervention
Estradiol +1 moredrug
Likely dose
Not stated in 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.
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Evaluate the Safety and Efficacy of TX-004HR in Postmenopausal Women With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy
In Brief
A Phase 3 clinical trial evaluating Estradiol and Placebo for Vulvovaginal Atrophy and 3 related conditions. Completed, enrolled 764 participants across 105 sites in 2 countries.
Detailed Summary
This study will assess the safety and efficacy of a new formulation of vaginal estradiol for the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvovaginal Atrophy, Menopause, Dyspareunia, Painful Intercourse
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartSep 2014
First PostedOct 2014
Primary CompletionOct 2015
TodayJul 2026
First PostedOct 1, 2014
Enrollment StartSep 1, 2014
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.8 years ago
Interventions
Estradioldrug
Placebodrug