Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study

• Status: Withdrawn
• Trial end date: 2019-12-06
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EndoCeutics Inc.
• Collaborator: AMAG Pharmaceuticals, Inc.
• Treatments: Dehydroepiandrosterone

Criteria

Inclusion Criteria (main criteria):

• Postmenopausal women (hysterectomized or not).

• Women between 40 and 80 years of age.

• 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.

• Diagnosis of HSDD confirmed by a qualified clinician.

• Willing to participate in the study and sign an informed consent.

Exclusion Criteria (main criteria):

• Chronic or acute life stress or major life change that could have interfered and continues to interfere significantly with sexual activity.

• Taking drugs which could be responsible for HSDD.

• Severe medical condition which can explain the loss of sexual desire.

• The administration of any investigational drug within 30 days of screening visit.

• Clinically significant abnormal serum biochemistry, urinalysis or hematology.