Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Menopause

Postmenopausal Vaginal Atrophy

Treatments

Drug: estradiol, 25 mcg

Drug: estradiol, 10 mcg

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00465192

VAG/PD/009/USA

Details and patient eligibility

About

This trial was conducted in the United States of America (USA). This trial aimed for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.

Enrollment

230 estimated patients

Sex

Female

Ages

45 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Generally healthy
Postmenopausal
Hysterectomized or non-hysterectomized
Moderate or severe vaginal dryness and soreness

Exclusion criteria

Known, suspected, or past history of breast cancer
Known, suspected, or past history of hormone-dependent tumor
Genital bleeding of unknown etiology
Acute thrombophlebitis or thromboembolic disorders or a past history of these conditions, associated with previous estrogen use
Vaginal infection
Use of exogenous corticosteroids or sex hormones within 8 weeks of starting active treatment in study
Use of vaginal, oral or vulvar homeopathic preparations within seven days of starting active treatment in study
History of treatment with diethylstilbestrol