Status:
COMPLETED
Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial
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 to evaluate safety and efficacy of 17-beta Estradiol in the treatment of atrophic vaginitis.
Eligibility Criteria
Inclusion
- Generally healthy
- Postmenopausal
- Hysterectomized or non-hysterectomized
- Moderate or severe vaginal dryness and soreness
- Successful completion of the study VAG/PD/009/USA
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
- 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
Key Trial Info
Start Date :
January 31 1995
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 1996
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00464971
Start Date
January 31 1995
End Date
November 30 1996
Last Update
March 1 2017
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