Overview

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Withdrawn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.