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)
Verified date | December 2013 |
Source | EndoCeutics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
EndoCeutics Inc. |
Canada,
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
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 |
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