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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Vasomotor Symptoms, Hot Flushes

Intervention / Treatment
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* Drug: Placebo
* Drug: DHEA and Acolbifene


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control (placebo)<br> | Drug: Placebo<br>* Placebo DHEA capsules (2) + placebo acolbifene capsule (1); daily oral dosing for 12 weeks.<br>|
| Experimental: DHEA + Acolbifene<br> | Drug: DHEA and Acolbifene<br>* DHEA capsules (2 x 50 mg) + acolbifene capsule (1 x 20 mg); daily oral dosing for 12 weeks.<br>* Other names: Prasterone; dehydroepiandrosterone; EM-652.HCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antiestrogen, Hot flush(es), Hot flash(es), Vasomotor symptoms, Dehydroepiandrosterone (DHEA), Prasterone, Acolbifene, Selective estrogen receptor modulator (SERM), Menopause, Postmenopausal women