To Study Generic Estradiol 10 mcg Vaginal Tablets in the Treatment of Vulvar and Vaginal Atrophy in Post Menopausal Women.

Launched by GLENMARK PHARMACEUTICALS LTD. INDIA · Jan 27, 2016

Keywords

ClinConnect Summary

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Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Female postmenopausal subjects aged \>30 to \<75 years
• • 2. 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
• • 3. Have \<5% superficial cells on vaginal smear cytology and vaginal pH \>5.0 at Visit 1
• • 4. Systolic blood pressure \<150mm Hg and diastolic blood pressure \<90mm Hg at Visit 1
• Exclusion Criteria:
• • 1. Known hypersensitivity to Estradiol vaginal tablet
• • 2. Screening mammogram or clinical breast examination results indicating any suspicion of breast malignancy.
• • 3. History of undiagnosed vaginal bleeding.
• • 4. History of significant risk factors for endometrial cancer
• • 5. For women with an intact uterus, screening vaginal ultrasonography showing endometrial thickness of ≥ 4 mm.

Trial Officials