Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis. An Extension Trial.
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrophic Vaginitis
Intervention: 25 micrograms 17-Beta Estradiol (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novo Nordisk Official(s) and/or principal investigator(s):
Jan Öhrström, MD, Study Director, Affiliation: Novo Nordisk
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.
Clinical Details
Official title: Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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.
Secondary outcome: Vaginal health, vaginal cytology and urethral cytology
Eligibility
Minimum age: 45 Years.
Maximum age: 80 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: January 1995
Last updated: April 23, 2007
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