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

Vasomotor Symptoms Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452373
• Other study ID #: ERC-207
• Status: Completed
• Phase: Phase 3
• First received: October 12, 2011
• Last updated: December 10, 2013
• Start date: October 2011
• Est. completion date: May 2013

Study information

• Verified date: December 2013
• Source: EndoCeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Flushing
• Hot Flashes
• Hot Flushes
• Vasomotor Symptoms

Intervention

Drug:
• Placebo
Placebo DHEA capsules (2) + placebo acolbifene capsule (1); daily oral dosing for 12 weeks.
• DHEA and Acolbifene
DHEA capsules (2 x 50 mg) + acolbifene capsule (1 x 20 mg); daily oral dosing for 12 weeks.

Locations

Country	Name	City	State
Canada	EndoCeutics site # 06	Bathurst	New Brunswick
Canada	EndoCeutics site # 70	Burlington	Ontario
Canada	EndoCeutics site # 69	Corunna	Ontario
Canada	EndoCeutics site # 04	Drummondville	Quebec
Canada	EndoCeutics site # 73	Kitchener	Ontario
Canada	EndoCeutics site # 71	London	Ontario
Canada	EndoCeutics site # 12	Montreal	Quebec
Canada	EndoCeutics site # 72	Newmarket	Ontario
Canada	EndoCeutics site # 01	Quebec City	Quebec
Canada	EndoCeutics site # 02	Quebec City	Quebec
Canada	EndoCeutics site # 68	Sarnia	Ontario
Canada	EndoCeutics site # 08	Shawinigan	Quebec
Canada	EndoCeutics site # 11	Sherbrooke	Quebec
Canada	EndoCeutics site # 18	St-Romuald	Quebec
Canada	EndoCeutics site # 67	Victoriaville	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
EndoCeutics Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Labrie F, Bélanger A, Labrie C, Candas B, Cusan L, Gomez JL. Bioavailability and metabolism of oral and percutaneous dehydroepiandrosterone in postmenopausal women. J Steroid Biochem Mol Biol. 2007 Oct;107(1-2):57-69. Epub 2007 Jun 8. — View Citation

Labrie F, Champagne P, Labrie C, Roy J, Laverdière J, Provencher L, Potvin M, Drolet Y, Pollak M, Panasci L, L'Espérance B, Dufresne J, Latreille J, Robert J, Samson B, Jolivet J, Yelle L, Cusan L, Diamond P, Candas B. Activity and safety of the antiestrogen EM-800, the orally active precursor of acolbifene, in tamoxifen-resistant breast cancer. J Clin Oncol. 2004 Mar 1;22(5):864-71. — View Citation

Labrie F, Labrie C, Bélanger A, Simard J, Gauthier S, Luu-The V, Mérand Y, Giguere V, Candas B, Luo S, Martel C, Singh SM, Fournier M, Coquet A, Richard V, Charbonneau R, Charpenet G, Tremblay A, Tremblay G, Cusan L, Veilleux R. EM-652 (SCH 57068), a third generation SERM acting as pure antiestrogen in the mammary gland and endometrium. J Steroid Biochem Mol Biol. 1999 Apr-Jun;69(1-6):51-84. Review. — View Citation

Labrie F. DHEA, important source of sex steroids in men and even more in women. Prog Brain Res. 2010;182:97-148. doi: 10.1016/S0079-6123(10)82004-7. — View Citation

Labrie F. Drug insight: breast cancer prevention and tissue-targeted hormone replacement therapy. Nat Clin Pract Endocrinol Metab. 2007 Aug;3(8):584-93. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Co-primary endpoint: change from baseline to week 12 in frequency of moderate to severe hot flushes.		12 weeks	No
Primary	Co-primary endpoint: change from baseline to week 12 in severity of moderate to severe hot flushes.		12 weeks	No
Secondary	Change from baseline to week 12 on vaginal atrophy parameters (superficial cells, parabasal cells, pH, vaginal atrophy symptoms).		12 weeks	No
Secondary	Change from baseline to week 12 on sexual function and quality of life as evaluated by appropriate questionnaires.		12 weeks	No
Secondary	Tolerance to systemic administration of DHEA and acolbifene.		12 weeks	Yes