Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis
Phase 3
Completed
- Conditions
- MenopausePostmenopausal 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
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