Conditions: Vaginal Atrophy
Keywords: Vulvar/Vaginal Atrophy Atrophic Vaginitis Dehydroepiandrosterone DHEA Prasterone Vaginorm Menopause Intrarosa
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 530
Healthy volunteers: no

Brief summary:
The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.

Detailed description:

Arms:
arm 1: 0.5% DHEA (intravaginal)

Interventions: intervention 1: DHEA
Intervention descriptions: intervention 1: Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.

Protocol document: