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

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)

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.

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.