Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Postmenopausal women whose last menstruation was at least two years prior to the time of screening

• At least 1 urogenital symptom (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, dyspareunia and vaginal bleeding associated with sexual activity

• Generally healthy

Exclusion Criteria:

• Exposure to exogenous sex steroid hormones (estrogen and/or progestin hormone replacement therapy) within past 3 months