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

Phase 3

Completed

• Conditions: Vasomotor Symptoms; Hot Flushes
• Interventions: Drug: Placebo; Drug: DHEA and Acolbifene

• Registration Number: NCT01452373
• Lead Sponsor: EndoCeutics Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-12
• Study First Submitted QC: 2011-10-13
• Study First Posted: 2011-10-14
• Primary Completion: 2012-12
• Study Completion: 2013-05
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-10
• Last Update Posted: 2013-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 238

Inclusion Criteria

• Postmenopausal women (non-hysterectomized or hysterectomized).
• Women between 40 and 75 years of age.
• Willing to participate in the study and sign an informed consent.
• Women having many moderate to severe hot flushes.
• For non-hysterectomized women, willing to have an endometrial biopsy at baseline and end of-study.

Main

Exclusion Criteria

• Undiagnosed abnormal genital bleeding.
• Hypertension equal to or above 140/90 mm Hg.
• The administration of any investigational drug within 30 days of screening visit.
• Endometrial hyperplasia (simple or complex hyperplasia with or without atypia), cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control (placebo)	Placebo	-
DHEA + Acolbifene	DHEA and Acolbifene	-

Primary Outcome Measures

Name	Time	Method
Co-primary endpoint: change from baseline to week 12 in severity of moderate to severe hot flushes.	12 weeks
Co-primary endpoint: change from baseline to week 12 in frequency of moderate to severe hot flushes.	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline to week 12 on vaginal atrophy parameters (superficial cells, parabasal cells, pH, vaginal atrophy symptoms).	12 weeks
Change from baseline to week 12 on sexual function and quality of life as evaluated by appropriate questionnaires.	12 weeks
Tolerance to systemic administration of DHEA and acolbifene.	12 weeks

Trial Locations

Locations (15)

EndoCeutics site # 04; 🇨🇦 Drummondville, Quebec, Canada

EndoCeutics site # 69; 🇨🇦 Corunna, Ontario, Canada

EndoCeutics site # 71; 🇨🇦 London, Ontario, Canada

EndoCeutics site # 72; 🇨🇦 Newmarket, Ontario, Canada

EndoCeutics site # 70; 🇨🇦 Burlington, Ontario, Canada

EndoCeutics site # 73; 🇨🇦 Kitchener, Ontario, Canada

EndoCeutics site # 01; 🇨🇦 Quebec City, Quebec, Canada

EndoCeutics site # 08; 🇨🇦 Shawinigan, Quebec, Canada

EndoCeutics site # 68; 🇨🇦 Sarnia, Ontario, Canada

EndoCeutics site # 02; 🇨🇦 Quebec City, Quebec, Canada

EndoCeutics site # 11; 🇨🇦 Sherbrooke, Quebec, Canada

EndoCeutics site # 18; 🇨🇦 St-Romuald, Quebec, Canada

EndoCeutics site # 12; 🇨🇦 Montreal, Quebec, Canada

EndoCeutics site # 67; 🇨🇦 Victoriaville, Quebec, Canada

EndoCeutics site # 06; 🇨🇦 Bathurst, New Brunswick, Canada