NCT01452373

Dehydroepiandrosterone (DHEA) + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women

DHEA + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women (Placebo Controlled, Double Blind and Randomized Phase III Study to Evaluate the Effects of 12-Week Treatment With DHEA (Prasterone) and Acolbifene on Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 238 (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 evaluate the efficacy of oral administration of dehydroepiandrosterone (DHEA) combined with acolbifene (a selective estrogen receptor modulator (SERM)) on vasomotor symptoms (hot flushes) in postmenopausal women.

Conditions

• Vasomotor Symptoms
• Hot Flushes

Interventions

Type	Name	Description
DRUG	Placebo	Placebo DHEA capsules (2) + placebo acolbifene capsule (1); daily oral dosing for 12 weeks.
DRUG	DHEA and Acolbifene	DHEA capsules (2 x 50 mg) + acolbifene capsule (1 x 20 mg); daily oral dosing for 12 weeks.

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-12-01
• Completion: 2013-05-01
• First posted: 2011-10-14
• Last updated: 2013-12-11

Locations

15 sites across 1 country: Canada