Clinical trial NCT03287232: Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoactive Sexual Desire Disorder
Keywords: Prasterone
DHEA
Menopause
Sexual Disorder
Lead sponsor: EndoCeutics Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-19
Enrollment: 653
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Sexual desire
timeFrame: 28 weeks
measure: Distress from low sexual desire
timeFrame: 28 weeks
Secondary outcomes:
measure: Satisfying sexual events (SSEs)
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Endoceutics site # 106
state: Alabama
city: Mobile
country: United States
facility: Endoceutics site # 104
state: Alabama
city: Tucson
country: United States
facility: Endoceutics site # 117
state: Arizona
city: Berkeley
country: United States
facility: Endoceutics site # 108
state: California
city: Los Alamitos
country: United States
facility: Endoceutics site # 121
state: California
city: Los Angeles
country: United States
facility: Endoceutics site #128
state: California
city: San Diego
country: United States
facility: Endoceutics site # 30
state: California
city: San Diego
country: United States
facility: Endoceutics site # 17
state: California
city: Denver
country: United States
facility: Endoceutics site # 36
state: Colorado
city: Denver
country: United States
facility: Endoceutics site # 52
state: Colorado
city: New London
country: United States
facility: Endoceutics site # 125
state: Connecticut
city: Washington
country: United States
facility: Endoceutics site # 7
state: District of Columbia
city: Bradenton
country: United States
facility: Endoceutics site # 95
state: Florida
city: Coral Gables
country: United States
facility: Endoceutics site # 120
state: Florida
city: Fort Myers
country: United States
facility: Endoceutics site # 99
state: Florida
city: Jacksonville
country: United States
facility: Endoceutics site # 26
state: Florida
city: Lake Worth
country: United States
facility: Endoceutics site # 60
state: Florida
city: Miami Lakes
country: United States
facility: Endoceutics site #118
state: Florida
city: North Miami
country: United States
facility: Endoceutics site # 54
state: Florida
city: Oviedo
country: United States
facility: Endoceutics site # 92
state: Florida
city: Saint Petersburg
country: United States
facility: Endoceutics site # 114
state: Florida
city: Sanford
country: United States
facility: Endoceutics site # 105
state: Florida
city: West Palm Beach
country: United States
facility: Endoceutics site # 89
state: Florida
city: West Palm Beach
country: United States
facility: Endoceutics site # 80
state: Florida
city: West Palm Beach
country: United States
facility: Endoceutics site # 90
state: Florida
city: Decatur
country: United States
facility: Endoceutics site # 107
state: Georgia
city: Roswell
country: United States
facility: Endoceutics site # 119
state: Georgia
city: Sandy Springs
country: United States
facility: Endoceutics site # 23
state: Georgia
city: Savannah
country: United States
facility: Endoceutics site # 91
state: Georgia
city: Wichita
country: United States
facility: Endoceutics site # 111
state: Kansas
city: Wichita
country: United States
facility: Endoceutics site # 55
state: Kansas
city: Lexington
country: United States
facility: Endoceutics site # 88
state: Kentucky
city: Louisville
country: United States
facility: Endoceutics site # 86
state: Kentucky
city: Boston
country: United States
facility: Endoceutics site # 103
state: Massachusetts
city: Kalamazoo
country: United States
facility: Endoceutics site # 22
state: Michigan
city: Portsmouth
country: United States
facility: Endoceutics site # 123
state: New Hampshire
city: Berlin
country: United States
facility: Endoceutics site # 101
state: New Jersey
city: Neptune
country: United States
facility: Endoceutics site # 50
state: New Jersey
city: New Brunswick
country: United States
facility: Endoceutics site # 44
state: New Jersey
city: Plainsboro
country: United States
facility: Endoceutics site # 81
state: New Jersey
city: New York
country: United States
facility: Endoceutics site # 20
state: New York
city: Poughkeepsie
country: United States
facility: Endoceutics site # 110
state: New York
city: Rochester
country: United States
facility: Endoceutics site # 97
state: New York
city: Raleigh
country: United States
facility: Endoceutics site # 58
state: North Carolina
city: Fargo
country: United States
facility: Endoceutics site # 115
state: North Dakota
city: Canton
country: United States
facility: Endoceutics site # 116
state: Ohio
city: Cleveland
country: United States
facility: Endoceutics site # 100
state: Ohio
city: Cleveland
country: United States
facility: Endoceutics site # 5
state: Ohio
city: Columbus
country: United States
facility: Endoceutics site # 93
state: Ohio
city: Philadelphia
country: United States
facility: Endoceutics site # 75
state: Pennsylvania
city: Bluffton
country: United States
facility: Endoceutics site # 127
state: South Carolina
city: Mount Pleasant
country: United States
facility: Endoceutics site # 126
state: South Carolina
city: Myrtle Beach
country: United States
facility: Endoceutics site # 112
state: South Carolina
city: Chattanooga
country: United States
facility: Endoceutics site # 94
state: Tennessee
city: Jackson
country: United States
facility: Endoceutics site # 64
state: Tennessee
city: Knoxville
country: United States
facility: Endoceutics site #124
state: Tennessee
city: Nashville
country: United States
facility: Endoceutics site #122
state: Tennessee
city: Houston
country: United States
facility: Endoceutics site # 82
state: Texas
city: San Antonio
country: United States
facility: Endoceutics site # 102
state: Texas
city: Charlottesville
country: United States
facility: Endoceutics site # 96
state: Virginia
city: Norfolk
country: United States
facility: Endoceutics site # 3
state: Virginia
city: Norfolk
country: United States
facility: Endoceutics site # 98
state: Virginia
city: Seattle
country: United States
facility: Endoceutics site # 76
state: Washington
city: Sarnia
country: Canada
facility: Endoceutics site # 68
state: Ontario
city: Lévis
country: Canada
facility: Endoceutics site # 18
state: Quebec
city: Québec
country: Canada
facility: Endoceutics site # 02
state: Quebec
city: Québec
country: Canada
facility: Endoceutics site # 77
state: Quebec
city: Québec
country: Canada
facility: Endoceutics site # 78
state: Quebec
city: Sherbrooke
country: Canada
facility: Endoceutics site # 11
state: Quebec
Study officials:
affiliation: EndoCeutics Inc.
name: Claude Labrie, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Maryland Center for Sexual Health
name: Leonard R. Derogatis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Labrie 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.
citation: Bouchard 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.