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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Menopause; Postmenopausal Vaginal Atrophy

Treatments: Drug: estradiol, 10 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00431132

2006-001629-24 (EudraCT Number)

VAG-1748

Details and patient eligibility

About

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.

Enrollment: 336 patients

Sex: Female

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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336 participants in 1 patient group

Vagifem® 10 mcg

Experimental group

Description:

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

Treatment:

Drug: estradiol, 10 mcg