NCT01256671

DHEA Against Vaginal Atrophy - Safety Study of 12 Months

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 530 (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 assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.

Conditions

• Vaginal Atrophy

Interventions

Type	Name	Description
DRUG	DHEA	Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-07-01
• Completion: 2012-12-01
• First posted: 2010-12-08
• Last updated: 2017-10-18
• Results posted: 2017-10-18

Locations

41 sites across 2 countries: United States, Canada