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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EndoCeutics Inc.
ClinicalTrials.gov Identifier:
NCT01452373
First received: October 12, 2011
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Vasomotor Symptoms
Hot Flushes
Drug: Placebo
Drug: DHEA and Acolbifene
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by EndoCeutics Inc.:

Primary Outcome Measures:
  • Co-primary endpoint: change from baseline to week 12 in frequency of moderate to severe hot flushes. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Co-primary endpoint: change from baseline to week 12 in severity of moderate to severe hot flushes. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to week 12 on vaginal atrophy parameters (superficial cells, parabasal cells, pH, vaginal atrophy symptoms). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 12 on sexual function and quality of life as evaluated by appropriate questionnaires. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Tolerance to systemic administration of DHEA and acolbifene. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 238
Study Start Date: October 2011
Study Completion Date: May 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452373

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

Publications:
Responsible Party: EndoCeutics Inc.
ClinicalTrials.gov Identifier: NCT01452373     History of Changes
Other Study ID Numbers: ERC-207
Study First Received: October 12, 2011
Last Updated: December 10, 2013
Health Authority: Canada: Health Canada

Keywords provided by EndoCeutics Inc.:
Hot flush(es)
Hot flash(es)
Vasomotor symptoms
Dehydroepiandrosterone (DHEA)
Prasterone
Acolbifene
Selective estrogen receptor modulator (SERM)
Antiestrogen
Menopause
Postmenopausal women

Additional relevant MeSH terms:
Flushing
Hot Flashes
Signs and Symptoms
Selective Estrogen Receptor Modulators
Dehydroepiandrosterone
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on September 30, 2014