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Trial record 5 of 236 for:    PRASTERONE

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

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: NCT03619005
Recruitment Status : Withdrawn (Business decision to not continue this study (only few subjects were screened).)
First Posted : August 7, 2018
Last Update Posted : November 19, 2019
Sponsor:
Collaborator:
AMAG Pharmaceuticals, Inc.
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 (HSDD) Drug: Placebo Vaginal Insert Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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) - Second Study (Placebo-Controlled, Double-Blind and Randomized Phase III Study of Intravaginal Prasterone)
Actual Study Start Date : November 13, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

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.

Active Comparator: 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 as evaluated by Questions 1 & 2 of the 19-items questionnaire titled Female Sexual Function Index (FSFI). For this outcome, Question 1 and Question 2 (corresponding to the desire domain) will be graded from 1 to 5 (score range) and then be multiplied by 0.6 (domain factor). The desire domain (sum of scores from Questions 1 & 2) has a minimum score of 1.2 and a maximum score of 6. Higher values represent a better outcome.

  2. Distress from low sexual desire [ Time Frame: 28 weeks ]
    Change from Baseline in distress from low sexual desire as evaluated by Question 13 of the 15-items questionnaire titled Female Sexual Distress Scale - Desire Arousal Orgasm (FSDS-DAO). For this outcome, Question 13 is graded from 0 to 4 and a lower value represents a better outcome.


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): NCT03619005


Locations
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United States, Alabama
Endoceutics site # 106
Huntsville, Alabama, United States, 35801
United States, California
Endoceutics site # 17
San Diego, California, United States, 92120
United States, Connecticut
Endoceutics site # 125
New London, Connecticut, United States, 06320
United States, Florida
Endoceutics site # 114
Saint Petersburg, Florida, United States, 33709
United States, Georgia
Endoceutics site # 119
Roswell, Georgia, United States, 30075
Endoceutics site # 91
Savannah, Georgia, United States, 31406
United States, New York
Endoceutics site # 20
New York, New York, United States, 10016
United States, North Dakota
Endoceutics site # 115
Fargo, North Dakota, United States, 58103
United States, South Carolina
Endoceutics site # 127
Bluffton, South Carolina, United States, 29910
United States, Texas
Endoceutics site # 102
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
EndoCeutics Inc.
AMAG Pharmaceuticals, Inc.
Investigators
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Study Chair: Claude Labrie, M.D., Ph.D. EndoCeutics Inc.

Publications:
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Responsible Party: EndoCeutics Inc.
ClinicalTrials.gov Identifier: NCT03619005    
Other Study ID Numbers: ERC-245
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
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
HSDD
Additional relevant MeSH terms:
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Dehydroepiandrosterone
Hypokinesia
Disease
Sexual Dysfunctions, Psychological
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs