Clinical trial NCT03619005: Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study
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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hypoactive Sexual Desire Disorder (HSDD)
Keywords: Prasterone
DHEA
Menopause
Sexual Disorder
HSDD
Lead sponsor: EndoCeutics Inc.
Sponsor class: INDUSTRY
Collaborators: name: AMAG Pharmaceuticals, Inc.
First posted: 2018-08-07
Enrollment: 0
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: San Diego
country: United States
facility: Endoceutics site # 17
state: California
city: New London
country: United States
facility: Endoceutics site # 125
state: Connecticut
city: Saint Petersburg
country: United States
facility: Endoceutics site # 114
state: Florida
city: Roswell
country: United States
facility: Endoceutics site # 119
state: Georgia
city: Savannah
country: United States
facility: Endoceutics site # 91
state: Georgia
city: New York
country: United States
facility: Endoceutics site # 20
state: New York
city: Fargo
country: United States
facility: Endoceutics site # 115
state: North Dakota
city: Bluffton
country: United States
facility: Endoceutics site # 127
state: South Carolina
city: San Antonio
country: United States
facility: Endoceutics site # 102
state: Texas
Study officials:
affiliation: EndoCeutics Inc.
name: Claude Labrie, M.D., Ph.D.
role: STUDY_CHAIR
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.