Conditions: Vaginal Atrophy
Keywords: Vulvar/vaginal atrophy Atrophic Vaginitis Dehydroepiandrosterone DHEA Prasterone Vaginorm Menopause Intrarosa
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 255
Healthy volunteers: no

Brief summary:
The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Placebo intervention 2: DHEA intervention 3: DHEA
Intervention descriptions: intervention 1: Placebo vaginal suppository intervention 2: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks. intervention 3: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.

Protocol document: