The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
653
Daily administration of a placebo vaginal insert.
Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.
Sexual desire
Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 \& 2).
Time frame: 28 weeks
Distress from low sexual desire
Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO.
Time frame: 28 weeks
Satisfying sexual events (SSEs)
Change from Baseline in the number of SSEs from a daily log of sexual activity.
Time frame: 28 weeks
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