Trials / Completed
CompletedNCT02253173
Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 764 (actual)
- Sponsor
- TherapeuticsMD · Industry
- Sex
- Female
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Estradiol | |
| DRUG | Placebo |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2015-10-01
- Completion
- 2015-10-01
- First posted
- 2014-10-01
- Last updated
- 2017-05-25
- Results posted
- 2017-05-25
Locations
105 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT02253173. Inclusion in this directory is not an endorsement.