Last updated on June 2018

PRASTERONE (DHEA) FOR THE TREATMENT OF HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD) - (PLACEBO-CONTROLLED, DOUBLE-BLIND AND RANDOMIZED PHASE III STUDY OF 24-WEEK INTRAVAGINAL PRASTERONE) - PROTOCOL ERC-242


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Sexual Dysfunction | Hypoactive Sexual Desire Disorder | Decreased Libido
  • Age: Between 40 - 80 Years
  • Gender: Female

Eligibility Criteria:

Inclusion (Partial Listing):

  1. Postmenopausal women (non-hysterectomized or hysterectomized).
  2. The postmenopausal women must satisfy either a, b or c:
    1. No menses for at least one year for non hysterectomized women, or
    2. Follicle stimulating hormone (FSH) levels > 40 IU/L or above (>) postmenopausal value of the laboratory where the FSH assay is performed in women with no menses > 6 months but < 12 months, or hysterectomized women who were premenopausal at the time of hysterectomy. A subject with previously measured elevated serum FSH (above postmenopausal level) does not need another serum FSH assay to meet the inclusion criteria, or
    3. Bilateral oophorectomy with or without hysterectomy six months or more before Day 1 visit.
  3. Women between 40 and 80 years of age.
  4. Being in a stable relationship with the opportunity for sexual activity or masturbation at least once a month during the last 6 months or longer (before screening visit) and during the following 8 months.
  5. Having a functioning sexual partner who is available for sexual activity at least 50% of the time permitting sexual activity at least once a month during the last 6 months or longer (before screening visit) and during the 8 months to follow.


Exclusion (Partial Listing):

  1. Chronic or acute life stress or major life change that could have interfered and continues to interfere significantly with sexual activity.
  2. Disorder better explained by a “nonsexual mental disorder, a consequence of severe relationship distress (e.g., partner violence) or other significant stressors”.
  3. Previous sexual trauma or abuse which may interfere with sexual activity.
  4. Taking drugs which could be responsible for HSDD

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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