Status:
COMPLETED
Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Menopause
Postmenopausal Vaginal Atrophy
Eligibility:
FEMALE
45-80 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Generally healthy
- Postmenopausal
- Hysterectomized or non-hysterectomized
- Moderate or severe vaginal dryness and soreness
Exclusion
- 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
Key Trial Info
Start Date :
August 31 1994
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 1995
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00465192
Start Date
August 31 1994
End Date
November 30 1995
Last Update
March 1 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.