Trials / Completed
CompletedNCT01256684
DHEA Against Vaginal Atrophy - 3-Month Efficacy Study
DHEA Against Vaginal Atrophy (Placebo-controlled, Double-blind and Randomized Phase III Study of 3-month Intravaginal DHEA)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 255 (actual)
- Sponsor
- EndoCeutics Inc. · Industry
- Sex
- Female
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Placebo vaginal suppository |
| DRUG | DHEA | Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks. |
| DRUG | DHEA | Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks. |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2011-08-01
- Completion
- 2011-11-01
- First posted
- 2010-12-08
- Last updated
- 2017-06-26
- Results posted
- 2017-04-25
Locations
33 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT01256684. Inclusion in this directory is not an endorsement.