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

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

Primary outcomes

• Sexual desire [28 weeks]: Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 \& 2).
• Distress from low sexual desire [28 weeks]: Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO.

Secondary outcomes

• Satisfying sexual events (SSEs) [28 weeks]: Change from Baseline in the number of SSEs from a daily log of sexual activity.

Sex: Female, ages: 40 Years to 80 Years

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.

• 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 19424093
• 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. PMID 26597311
• 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. PMID 26725467

• Claude Labrie, M.D., Ph.D., Study chair, EndoCeutics Inc.
• Leonard R. Derogatis, Ph.D., Principal investigator, Maryland Center for Sexual Health