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

EndoCeutics

Status and phase: Completed; Phase 3

Conditions: Hypoactive Sexual Desire Disorder

Treatments: Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert; Drug: Placebo Vaginal Insert

Study type: Interventional

Funder types: Industry

Identifiers

NCT03287232

ERC-242

Details and patient eligibility

About

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

Enrollment: 653 patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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653 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo Vaginal Insert

Prasterone

Experimental group

Treatment:

Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert