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

Phase 3

Completed

• Conditions: Menopause; Postmenopausal Vaginal Atrophy

• Registration Number: NCT00465192
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1994-08-31
• Primary Completion: 1995-11-30
• Study Completion: 1995-11-30
• Study First Submitted: 2007-04-23
• Study First Submitted QC: 2007-04-23
• Study First Posted: 2007-04-24
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 230

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Relief of vaginal symptoms	following 12 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Hematology and chemisty tests, and endometrial biopsy
Vaginal and urethral cytology, and grading of vaginal health
Adverse events