Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial
Phase 3
Completed
- Conditions
- Postmenopausal Vaginal AtrophyMenopause
- Registration Number
- NCT00464971
- Lead Sponsor
- Novo Nordisk A/S
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 102
Inclusion Criteria
- Generally healthy
- Postmenopausal
- Hysterectomized or non-hysterectomized
- Moderate or severe vaginal dryness and soreness
- Successful completion of the study VAG/PD/009/USA
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
- Subjects who had adverse events during the final visit, or discontinued prematurely, or were noncompliant in VAG/PD/009/USA
- Exposure to any investigational new drug (other than what was dispensed in VAG/PD/009/USA) within the previous 30 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Vaginal health, vaginal cytology and urethral cytology