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

Hypoactive Sexual Desire Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03287232
• Other study ID #: ERC-242
• Status: Completed
• Phase: Phase 3
• Start date: October 16, 2017
• Est. completion date: July 22, 2019

Study information

• Verified date: April 2021
• Source: EndoCeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 653
• Est. completion date: July 22, 2019
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Hypoactive Sexual Desire Disorder
• Hypokinesia
• Sexual Dysfunctions, Psychological

Intervention

Drug:
• Placebo Vaginal Insert
Daily administration of a placebo vaginal insert.
• Prasterone 6.5 mg (0.50%) Vaginal Insert
Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.

Locations

Country	Name	City	State
Canada	Endoceutics site # 18	Lévis	Quebec
Canada	Endoceutics site # 02	Québec	Quebec
Canada	Endoceutics site # 77	Québec	Quebec
Canada	Endoceutics site # 78	Québec	Quebec
Canada	Endoceutics site # 68	Sarnia	Ontario
Canada	Endoceutics site # 11	Sherbrooke	Quebec
United States	Endoceutics site # 108	Berkeley	California
United States	Endoceutics site # 101	Berlin	New Jersey
United States	Endoceutics site # 127	Bluffton	South Carolina
United States	Endoceutics site # 103	Boston	Massachusetts
United States	Endoceutics site # 95	Bradenton	Florida
United States	Endoceutics site # 116	Canton	Ohio
United States	Endoceutics site # 96	Charlottesville	Virginia
United States	Endoceutics site # 94	Chattanooga	Tennessee
United States	Endoceutics site # 100	Cleveland	Ohio
United States	Endoceutics site # 5	Cleveland	Ohio
United States	Endoceutics site # 93	Columbus	Ohio
United States	Endoceutics site # 120	Coral Gables	Florida
United States	Endoceutics site # 107	Decatur	Georgia
United States	Endoceutics site # 36	Denver	Colorado
United States	Endoceutics site # 52	Denver	Colorado
United States	Endoceutics site # 115	Fargo	North Dakota
United States	Endoceutics site # 99	Fort Myers	Florida
United States	Endoceutics site # 82	Houston	Texas
United States	Endoceutics site # 106	Huntsville	Alabama
United States	Endoceutics site # 64	Jackson	Tennessee
United States	Endoceutics site # 26	Jacksonville	Florida
United States	Endoceutics site # 22	Kalamazoo	Michigan
United States	Endoceutics site #124	Knoxville	Tennessee
United States	Endoceutics site # 60	Lake Worth	Florida
United States	Endoceutics site # 88	Lexington	Kentucky
United States	Endoceutics site # 121	Los Alamitos	California
United States	Endoceutics site #128	Los Angeles	California
United States	Endoceutics site # 86	Louisville	Kentucky
United States	Endoceutics site #118	Miami Lakes	Florida
United States	Endoceutics site # 104	Mobile	Alabama
United States	Endoceutics site # 126	Mount Pleasant	South Carolina
United States	Endoceutics site # 112	Myrtle Beach	South Carolina
United States	Endoceutics site #122	Nashville	Tennessee
United States	Endoceutics site # 50	Neptune	New Jersey
United States	Endoceutics site # 44	New Brunswick	New Jersey
United States	Endoceutics site # 125	New London	Connecticut
United States	Endoceutics site # 20	New York	New York
United States	Endoceutics site # 3	Norfolk	Virginia
United States	Endoceutics site # 98	Norfolk	Virginia
United States	Endoceutics site # 54	North Miami	Florida
United States	Endoceutics site # 92	Oviedo	Florida
United States	Endoceutics site # 75	Philadelphia	Pennsylvania
United States	Endoceutics site # 81	Plainsboro	New Jersey
United States	Endoceutics site # 123	Portsmouth	New Hampshire
United States	Endoceutics site # 110	Poughkeepsie	New York
United States	Endoceutics site # 58	Raleigh	North Carolina
United States	Endoceutics site # 97	Rochester	New York
United States	Endoceutics site # 119	Roswell	Georgia
United States	Endoceutics site # 114	Saint Petersburg	Florida
United States	Endoceutics site # 102	San Antonio	Texas
United States	Endoceutics site # 17	San Diego	California
United States	Endoceutics site # 30	San Diego	California
United States	Endoceutics site # 23	Sandy Springs	Georgia
United States	Endoceutics site # 105	Sanford	Florida
United States	Endoceutics site # 91	Savannah	Georgia
United States	Endoceutics site # 76	Seattle	Washington
United States	Endoceutics site # 117	Tucson	Arizona
United States	Endoceutics site # 7	Washington	District of Columbia
United States	Endoceutics site # 80	West Palm Beach	Florida
United States	Endoceutics site # 89	West Palm Beach	Florida
United States	Endoceutics site # 90	West Palm Beach	Florida
United States	Endoceutics site # 111	Wichita	Kansas
United States	Endoceutics site # 55	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
EndoCeutics Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

Bouchard C, Labrie F, Derogatis L, Girard G, Ayotte N, Gallagher J, Cusan L, Archer DF, Portman D, Lavoie L, Beauregard A, Côté 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. — View Citation

Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dubé R, Côté 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. — View Citation

Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Côté I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur É; 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual desire	Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 & 2).	28 weeks
Primary	Distress from low sexual desire	Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO.	28 weeks
Secondary	Satisfying sexual events (SSEs)	Change from Baseline in the number of SSEs from a daily log of sexual activity.	28 weeks