Overview

Endometrial Safety of a Low Dose of VagifemĀ® 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 (VagifemĀ®) 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