Conditions: Vulvovaginal Atrophy
Keywords: vaginal dryness vaginal atrophy estrogen
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 576
Healthy volunteers: no

Brief summary:
The primary objective of this study is to compare the efficacy of WC3011 with placebo vaginal gel in postmenopausal women for the relief of vaginal dryness caused by vaginal atrophy as measured by self-assessment, vaginal pH and vaginal smear.

Detailed description:

Arms:
arm 1: Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks. arm 2: WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.

Interventions: intervention 1: Vehicle intervention 2: WC3011 Estradiol Vaginal Cream
Intervention descriptions: intervention 1: Vehicle Cream applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks intervention 2: WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks

Protocol document: