At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
Estradiol +1 moredrug
Likely dose
Estradiol 10 µgfrom 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 1, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of TX-12-004-HR in Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy (VVA)
In Brief
A Phase 2 clinical trial evaluating Estradiol and placebo for Menopause and 3 related conditions. Completed, enrolled 50 participants across 1 site.
Detailed Summary
The study was designed to evaluate the efficacy and safety of TX-12-004-HR 10 μg in treating moderate to severe symptoms of vaginal atrophy associated with menopause after 14 days of treatment, and to estimate the effect size and variability of vulvovaginal atrophy endpoints. In addition, the systemic exposure to estradiol from single and multiple doses of TX-12-004-HR was to be investigated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenopause, Vulvovaginal Atrophy, Painful Intercourse, Dyspareunia
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
Primary CompletionSep 2013
First PostedMay 2015
TodayJul 2026
First PostedMay 20, 2015
Enrollment StartJul 1, 2013
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.1 years ago
Interventions
Estradioldrug
1 10 µg capsule inserted vaginally for 14 days.
placebodrug
1 placebo capsule inserted vaginally for 14 days.