Hypoactive Sexual Desire Disorder (HSDD)
Conditions
Keywords
Prasterone, DHEA, Menopause, Sexual Disorder, HSDD
Brief summary
The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.
Interventions
Daily administration of a placebo vaginal insert.
Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.
Sponsors
AMAG Pharmaceuticals, Inc.
EndoCeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sexual desire | 28 weeks | Change from Baseline in sexual desire as evaluated by Questions 1 & 2 of the 19-items questionnaire titled Female Sexual Function Index (FSFI). For this outcome, Question 1 and Question 2 (corresponding to the desire domain) will be graded from 1 to 5 (score range) and then be multiplied by 0.6 (domain factor). The desire domain (sum of scores from Questions 1 & 2) has a minimum score of 1.2 and a maximum score of 6. Higher values represent a better outcome. |
| Distress from low sexual desire | 28 weeks | Change from Baseline in distress from low sexual desire as evaluated by Question 13 of the 15-items questionnaire titled Female Sexual Distress Scale - Desire Arousal Orgasm (FSDS-DAO). For this outcome, Question 13 is graded from 0 to 4 and a lower value represents a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfying sexual events (SSEs) | 28 weeks | Change from Baseline in the number of SSEs from a daily log of sexual activity. |
Countries
United States
Outcome results
None listed