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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
238
Placebo DHEA capsules (2) + placebo acolbifene capsule (1); daily oral dosing for 12 weeks.
DHEA capsules (2 x 50 mg) + acolbifene capsule (1 x 20 mg); daily oral dosing for 12 weeks.
EndoCeutics site # 06
Bathurst, New Brunswick, Canada
EndoCeutics site # 70
Burlington, Ontario, Canada
EndoCeutics site # 69
Corunna, Ontario, Canada
Co-primary endpoint: change from baseline to week 12 in frequency of moderate to severe hot flushes.
Time frame: 12 weeks
Co-primary endpoint: change from baseline to week 12 in severity of moderate to severe hot flushes.
Time frame: 12 weeks
Change from baseline to week 12 on vaginal atrophy parameters (superficial cells, parabasal cells, pH, vaginal atrophy symptoms).
Time frame: 12 weeks
Change from baseline to week 12 on sexual function and quality of life as evaluated by appropriate questionnaires.
Time frame: 12 weeks
Tolerance to systemic administration of DHEA and acolbifene.
Time frame: 12 weeks
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EndoCeutics site # 73
Kitchener, Ontario, Canada
EndoCeutics site # 71
London, Ontario, Canada
EndoCeutics site # 72
Newmarket, Ontario, Canada
EndoCeutics site # 68
Sarnia, Ontario, Canada
EndoCeutics site # 04
Drummondville, Quebec, Canada
EndoCeutics site # 12
Montreal, Quebec, Canada
EndoCeutics site # 02
Québec, Quebec, Canada
...and 5 more locations