To Study Generic Estradiol 10 mcg Vaginal Tablets in the Treatment of Vulvar and Vaginal Atrophy in Post Menopausal Women.
Completed · Phase 3 · Has a placebo group
Conditions studied: Vulvar and Vaginal Atrophy
In brief
This is a Randomized, Parallel-Group, Placebo- Controlled, Multicenter Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) in Female Subjects with Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated with Menopause.
Key facts
- Study ID
- NCT02668796
- Run by
- Glenmark Pharmaceuticals Ltd. India
- People needed
- 522
- Starts
- 2016-01-01
- Expected to finish
- 2016-09-21
- Last updated by the study team
- 2017-11-14
Who can join
Age: 30 and older, up to 75. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Female postmenopausal subjects aged >30 to <75 years
- At least 1 subject assessed moderate to severe symptom of vulvar and vaginal atrophy among the following that is identified as being the most bothersome to her
- vaginal dryness
- vaginal and/or vulvar irritation/ itching
- dysuria
- vaginal pain associated with sexual activity
- presence of vaginal bleeding associated with sexual activity
- Have <5% superficial cells on vaginal smear cytology and vaginal pH >5.0 at Visit 1
- Systolic blood pressure <150mm Hg and diastolic blood pressure <90mm Hg at Visit 1
You may not qualify if…
- Known hypersensitivity to Estradiol vaginal tablet
- Screening mammogram or clinical breast examination results indicating any suspicion of breast malignancy.
- History of undiagnosed vaginal bleeding.
- History of significant risk factors for endometrial cancer
- For women with an intact uterus, screening vaginal ultrasonography showing endometrial thickness of ≥ 4 mm.
Where it is running
- Glenmark Pharmaceuticals Inc. — Mahwah, New Jersey, United States
Full record on ClinicalTrials.gov
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