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

October 12, 2011
December 10, 2013
October 2011
December 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01452373 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Vasomotor Symptoms
  • Hot Flushes
  • 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.
    Other Name: Prasterone; dehydroepiandrosterone; EM-652.HCl
  • Placebo Comparator: Control (placebo)
    Intervention: Drug: Placebo
  • Experimental: DHEA + Acolbifene
    Intervention: Drug: DHEA and Acolbifene

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
238
May 2013
December 2012   (final data collection date for primary outcome measure)

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.
Female
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01452373
ERC-207
No
EndoCeutics Inc.
EndoCeutics Inc.
Not Provided
Principal Investigator: Leonello Cusan, M.D., Ph.D. Clinique de Recherche en Traitements Hormonaux, 2785 blvd Laurier - Suite SS5, Quebec, QC, Canada
EndoCeutics Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP