Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrophic Vaginitis
Intervention: 10 micrograms 17-Beta Estradiol (Drug); 25 micrograms 17-Beta Estradiol (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novo Nordisk Official(s) and/or principal investigator(s):
Jan Öhrström, MD, Study Director, Affiliation: Novo Nordisk
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.
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Comparing the Efficacy and Safety of 17-Beta Estradiol 10 Micrograms and 25 Micrograms (Vagifem) Doses in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Relief of vaginal symptoms following 12 weeks of treatment.
Secondary outcome: Adverse Events, hematology and chemistry tests, and endometrial biopsy.Vaginal and urethral cytology, and grading of vaginal health.
Eligibility
Minimum age: 45 Years.
Maximum age: 80 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: August 1994
Last updated: April 23, 2007
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