Clinical Trial: Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis
Brief Summary: This trial was conducted in the United States of America (USA). This trial aimed to evaluate safety and efficacy of 17-beta Estradiol in the treatment of atrophic vaginitis.
Detailed Summary:
Sponsor: Novo Nordisk A/S
Current Primary Outcome:
- Relief of vaginal symptoms [ Time Frame: over 12 months of treatment ]
- Safety: Long-term effect on the endometrium assessed through evaluation of endometrial biopsies. AEs, clinical laboratory data and serum hormone levels
Original Primary Outcome:
- Relief of vaginal symptoms over 12 months of treatment.
- Safety: Long-term effect on the endometrium assessed through evaluation of endometrial biopsies. AEs, clinical laboratory data and serum hormone levels.
Current Secondary Outcome: Vaginal health, vaginal cytology and urethral cytology
Original Secondary Outcome: Same as current
Information By: Novo Nordisk A/S
Dates:
Date Received: April 23, 2007
Date Started: January 31, 1995
Date Completion:
Last Updated: February 28, 2017
Last Verified: February 2017
