Status:
COMPLETED
Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
Lead Sponsor:
EndoCeutics Inc.
Conditions:
Hypoactive Sexual Desire Disorder
Eligibility:
FEMALE
40-80 years
Phase:
PHASE3
Brief Summary
The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2019
Estimated Enrollment :
653 Patients enrolled
Trial Details
Trial ID
NCT03287232
Start Date
October 16 2017
End Date
July 22 2019
Last Update
April 9 2021
Active Locations (69)
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1
Endoceutics site # 106
Huntsville, Alabama, United States, 35801
2
Endoceutics site # 104
Mobile, Alabama, United States, 36608
3
Endoceutics site # 117
Tucson, Arizona, United States, 85712
4
Endoceutics site # 108
Berkeley, California, United States, 84704