Conditions: Postmenopausal Vulvovaginal Atrophy
Keywords: Postmenopausal Women, Vaginal Dryness
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 722
Healthy volunteers: no

Brief summary:
Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.

Detailed description:

Arms:
arm 1: WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks. arm 2: Vehicle applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks. arm 3: WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks. arm 4: Vehicle applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.

Interventions: intervention 1: WC3011 Estradiol Vaginal Cream intervention 2: Vehicle
Intervention descriptions: intervention 1: WC3011 estradiol vaginal cream administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks intervention 2: Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.

Protocol document: