Study Stopped
Business decision to not continue this study (only few subjects were screened).
Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study
1 other identifier
interventional
N/A
1 country
10
Brief Summary
The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2018
Shorter than P25 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2018
CompletedFirst Posted
Study publicly available on registry
August 7, 2018
CompletedStudy Start
First participant enrolled
November 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2019
CompletedJuly 31, 2020
July 1, 2020
9 months
August 2, 2018
July 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Sexual desire
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.
28 weeks
Distress from low sexual desire
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.
28 weeks
Secondary Outcomes (1)
Satisfying sexual events (SSEs)
28 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORPrasterone
ACTIVE COMPARATORInterventions
Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EndoCeutics Inc.lead
- AMAG Pharmaceuticals, Inc.collaborator
Study Sites (10)
Endoceutics site # 106
Huntsville, Alabama, 35801, United States
Endoceutics site # 17
San Diego, California, 92120, United States
Endoceutics site # 125
New London, Connecticut, 06320, United States
Endoceutics site # 114
St. Petersburg, Florida, 33709, United States
Endoceutics site # 119
Roswell, Georgia, 30075, United States
Endoceutics site # 91
Savannah, Georgia, 31406, United States
Endoceutics site # 20
New York, New York, 10016, United States
Endoceutics site # 115
Fargo, North Dakota, 58103, United States
Endoceutics site # 127
Bluffton, South Carolina, 29910, United States
Endoceutics site # 102
San Antonio, Texas, 78229, United States
Related Publications (3)
Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berger L, Gilbert L, Martel C, Balser J. Effect of intravaginal dehydroepiandrosterone (Prasterone) on libido and sexual dysfunction in postmenopausal women. Menopause. 2009 Sep-Oct;16(5):923-31. doi: 10.1097/gme.0b013e31819e85c6.
PMID: 19424093BACKGROUNDLabrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; Members of the VVA Prasterone Research Group. Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med. 2015 Dec;12(12):2401-12. doi: 10.1111/jsm.13045. Epub 2015 Nov 23.
PMID: 26597311BACKGROUNDBouchard C, Labrie F, Derogatis L, Girard G, Ayotte N, Gallagher J, Cusan L, Archer DF, Portman D, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Group. Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC-230 open-label study. Horm Mol Biol Clin Investig. 2016 Mar;25(3):181-90. doi: 10.1515/hmbci-2015-0044.
PMID: 26725467BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Claude Labrie, M.D., Ph.D.
EndoCeutics Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2018
First Posted
August 7, 2018
Study Start
November 13, 2018
Primary Completion
August 15, 2019
Study Completion
December 6, 2019
Last Updated
July 31, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share