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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03287232
Recruitment Status : Completed
First Posted : September 19, 2017
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
EndoCeutics Inc.

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

Condition or disease Intervention/treatment Phase
Hypoactive Sexual Desire Disorder Drug: Placebo Vaginal Insert Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 653 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - (Placebo-Controlled, Double Blind and Randomized Phase III Study of Intravaginal Prasterone)
Actual Study Start Date : October 16, 2017
Actual Primary Completion Date : March 8, 2019
Actual Study Completion Date : July 22, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Prasterone

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo Vaginal Insert
Daily administration of a placebo vaginal insert.
Experimental: Prasterone Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert
Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.


Outcome Measures
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Primary Outcome Measures :
  1. Sexual desire [ Time Frame: 28 weeks ]
    Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 & 2).

  2. Distress from low sexual desire [ Time Frame: 28 weeks ]
    Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO.


Secondary Outcome Measures :
  1. Satisfying sexual events (SSEs) [ Time Frame: 28 weeks ]
    Change from Baseline in the number of SSEs from a daily log of sexual activity.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287232


Locations
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Sponsors and Collaborators
EndoCeutics Inc.
Investigators
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Study Chair: Claude Labrie, M.D., Ph.D. EndoCeutics Inc.
Principal Investigator: Leonard R. Derogatis, Ph.D. Maryland Center for Sexual Health
More Information
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Publications:

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Responsible Party: EndoCeutics Inc.
ClinicalTrials.gov Identifier: NCT03287232    
Other Study ID Numbers: ERC-242
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EndoCeutics Inc.:
Prasterone
DHEA
Menopause
Sexual Disorder
Additional relevant MeSH terms:
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Hypokinesia
Disease
Sexual Dysfunctions, Psychological
Pathologic Processes
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Mental Disorders
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs