Conditions: Menopause Postmenopausal Vaginal Atrophy
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 336
Healthy volunteers: yes

Brief summary:
This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.

Detailed description:

Arms:
arm 1: One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks

Interventions: intervention 1: estradiol, 10 mcg
Intervention descriptions: intervention 1: Tablets, administered intravaginally twice weekly

Protocol document: