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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01452373
Recruitment Status : Completed
First Posted : October 14, 2011
Last Update Posted : December 11, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Vasomotor Symptoms Hot Flushes Drug: Placebo Drug: DHEA and Acolbifene Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : October 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Prasterone

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 Name: Prasterone; dehydroepiandrosterone; EM-652.HCl

Primary Outcome Measures :
  1. Co-primary endpoint: change from baseline to week 12 in frequency of moderate to severe hot flushes. [ Time Frame: 12 weeks ]
  2. Co-primary endpoint: change from baseline to week 12 in severity of moderate to severe hot flushes. [ Time Frame: 12 weeks ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01452373

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Canada, New Brunswick
EndoCeutics site # 06
Bathurst, New Brunswick, Canada, E2A 4X7
Canada, Ontario
EndoCeutics site # 70
Burlington, Ontario, Canada, L7M 4Y1
EndoCeutics site # 69
Corunna, Ontario, Canada, N0N 1G0
EndoCeutics site # 73
Kitchener, Ontario, Canada, N2G 1H6
EndoCeutics site # 71
London, Ontario, Canada, N5Y 5K7
EndoCeutics site # 72
Newmarket, Ontario, Canada, L3Y 5G8
EndoCeutics site # 68
Sarnia, Ontario, Canada, N7T 4X3
Canada, Quebec
EndoCeutics site # 04
Drummondville, Quebec, Canada, J2B 7T1
EndoCeutics site # 12
Montreal, Quebec, Canada, H4N 3C5
EndoCeutics site # 02
Quebec City, Quebec, Canada, G1S 2L6
EndoCeutics site # 01
Quebec City, Quebec, Canada, G1V 2L9
EndoCeutics site # 08
Shawinigan, Quebec, Canada, G9N 2H6
EndoCeutics site # 11
Sherbrooke, Quebec, Canada, J1H 1Z1
EndoCeutics site # 18
St-Romuald, Quebec, Canada, G6W 5M6
EndoCeutics site # 67
Victoriaville, Quebec, Canada, G6P 6P6
Sponsors and Collaborators
EndoCeutics Inc.
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Principal Investigator: Leonello Cusan, M.D., Ph.D. Clinique de Recherche en Traitements Hormonaux, 2785 blvd Laurier - Suite SS5, Quebec, QC, Canada
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Responsible Party: EndoCeutics Inc. Identifier: NCT01452373    
Other Study ID Numbers: ERC-207
First Posted: October 14, 2011    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013
Keywords provided by EndoCeutics Inc.:
Hot flush(es)
Hot flash(es)
Vasomotor symptoms
Dehydroepiandrosterone (DHEA)
Selective estrogen receptor modulator (SERM)
Postmenopausal women
Additional relevant MeSH terms:
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Hot Flashes
Skin Manifestations
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs