NCT01846442

Topical DHEA Against Vaginal Atrophy

Topical DHEA Against Vaginal Atrophy (3-Month Placebo-Controlled Double-Blind Randomized Phase III Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: EndoCeutics Inc. · Industry
• Sex: Female
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from vaginal atrophy.

Conditions

• Vaginal Atrophy

Interventions

Type	Name	Description
DRUG	Placebo	Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
DRUG	DHEA (0.25%)	Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DRUG	DHEA (0.5%)	Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
DRUG	DHEA (1.0%)	Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-05-01
• Completion: 2008-10-01
• First posted: 2013-05-03
• Last updated: 2017-08-29
• Results posted: 2017-04-28

Locations

8 sites across 2 countries: United States, Canada