Conditions: Vulvovaginal Atrophy
Keywords: Vulvovaginal Atrophy Dyspareunia Postmenopausal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 550
Healthy volunteers: no

Brief summary:
The purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant self-assessment when compared to vehicle.

Detailed description:

Arms:
arm 1: Vehicle applied to the vagina daily for 14 days followed by dosing 3 times per week for 10 weeks. arm 2: WC3011 Estradiol vaginal cream applied daily for 14 days followed by dosing 3 times per week for 10 weeks.

Interventions: intervention 1: WC3011 Estradiol Vaginal Cream intervention 2: Vehicle
Intervention descriptions: intervention 1: Daily for 14 days followed by 3 times per week for 10 weeks intervention 2: Daily for 14 days followed by 3 times per week for 10 weeks

Protocol document: