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

• Status: Completed
• Trial end date: 2016-09-21
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Glenmark Pharmaceuticals Ltd. India
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

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.