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

December 10, 2013 updated by: EndoCeutics Inc.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • New Brunswick
      • Bathurst, New Brunswick, Canada, E2A 4X7
        • EndoCeutics site # 06
    • Ontario
      • Burlington, Ontario, Canada, L7M 4Y1
        • EndoCeutics site # 70
      • Corunna, Ontario, Canada, N0N 1G0
        • EndoCeutics site # 69
      • Kitchener, Ontario, Canada, N2G 1H6
        • EndoCeutics site # 73
      • London, Ontario, Canada, N5Y 5K7
        • EndoCeutics site # 71
      • Newmarket, Ontario, Canada, L3Y 5G8
        • EndoCeutics site # 72
      • Sarnia, Ontario, Canada, N7T 4X3
        • EndoCeutics site # 68
    • Quebec
      • Drummondville, Quebec, Canada, J2B 7T1
        • EndoCeutics site # 04
      • Montreal, Quebec, Canada, H4N 3C5
        • EndoCeutics site # 12
      • Quebec City, Quebec, Canada, G1S 2L6
        • EndoCeutics site # 02
      • Quebec City, Quebec, Canada, G1V 2L9
        • EndoCeutics site # 01
      • Shawinigan, Quebec, Canada, G9N 2H6
        • EndoCeutics site # 08
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • EndoCeutics site # 11
      • St-Romuald, Quebec, Canada, G6W 5M6
        • EndoCeutics site # 18
      • Victoriaville, Quebec, Canada, G6P 6P6
        • EndoCeutics site # 67

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Main 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control (placebo)
Drug: Placebo
Placebo DHEA capsules (2) + placebo acolbifene capsule (1); daily oral dosing for 12 weeks.
EXPERIMENTAL: DHEA + Acolbifene
Drug: DHEA and Acolbifene
DHEA capsules (2 x 50 mg) + acolbifene capsule (1 x 20 mg); daily oral dosing for 12 weeks.
Other Names:
  • Prasterone; dehydroepiandrosterone; EM-652.HCl

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EndoCeutics Inc.

Investigators

  • Principal Investigator: Leonello Cusan, M.D., Ph.D., Clinique de Recherche en Traitements Hormonaux, 2785 blvd Laurier - Suite SS5, Quebec, QC, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

October 12, 2011

First Submitted That Met QC Criteria

October 13, 2011

First Posted (ESTIMATE)

October 14, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERC-207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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