Hot Flushes, Vasomotor Symptoms
Conditions
Keywords
Hot flush(es), Hot flash(es), Vasomotor symptoms, Dehydroepiandrosterone (DHEA), Prasterone, Acolbifene, Selective estrogen receptor modulator (SERM), Antiestrogen, Menopause, Postmenopausal women
Brief 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.
Interventions
DRUGPlacebo
Placebo DHEA capsules (2) + placebo acolbifene capsule (1); daily oral dosing for 12 weeks.
DRUGDHEA and Acolbifene
DHEA capsules (2 x 50 mg) + acolbifene capsule (1 x 20 mg); daily oral dosing for 12 weeks.
Sponsors
EndoCeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary endpoint: change from baseline to week 12 in frequency of moderate to severe hot flushes. | 12 weeks |
| Co-primary endpoint: change from baseline to week 12 in severity of moderate to severe hot flushes. | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to week 12 on vaginal atrophy parameters (superficial cells, parabasal cells, pH, vaginal atrophy symptoms). | 12 weeks |
| Change from baseline to week 12 on sexual function and quality of life as evaluated by appropriate questionnaires. | 12 weeks |
| Tolerance to systemic administration of DHEA and acolbifene. | 12 weeks |
Countries
Canada
Outcome results
None listed