Clinical Trial: Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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 Summary:
Sponsor: Novo Nordisk A/S
Current Primary Outcome: Relief of vaginal symptoms [ Time Frame: following 12 weeks of treatment. ]
Original Primary Outcome: Relief of vaginal symptoms following 12 weeks of treatment.
Current Secondary Outcome:
- Adverse events
- Hematology and chemisty tests, and endometrial biopsy
- Vaginal and urethral cytology, and grading of vaginal health
Original Secondary Outcome:
- Adverse Events, hematology and chemistry tests, and endometrial biopsy.
- Vaginal and urethral cytology, and grading of vaginal health.
Information By: Novo Nordisk A/S
Dates:
Date Received: April 23, 2007
Date Started: August 31, 1994
Date Completion:
Last Updated: February 28, 2017
Last Verified: February 2017
