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

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ClinicalTrials.gov Identifier: NCT03287232
Recruitment Status : Active, not recruiting
First Posted : September 19, 2017
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
EndoCeutics Inc.

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 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
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Prasterone

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.




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.



Information from the National Library of Medicine

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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.

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


  Show 69 Study Locations
Sponsors and Collaborators
EndoCeutics Inc.
Investigators
Study Chair: Fernand Labrie, M.D., Ph.D. EndoCeutics Inc.
Principal Investigator: Leonard R. Derogatis, Ph.D. Maryland Center for Sexual Health

Publications:
Responsible Party: EndoCeutics Inc.
ClinicalTrials.gov Identifier: NCT03287232     History of Changes
Other Study ID Numbers: ERC-242
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Disease
Hypokinesia
Sexual Dysfunctions, Psychological
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs