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

Overview

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.

Full Title of Study: “A Phase III Investigator-Blind, Randomized, Parallel-Group, Placebo- Controlled, Multicentre Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) Administered for 14 Days and Compare Both Active Treatments to a Placebo Control in Female Subjects With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated With Menopause.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: September 21, 2016

Interventions

  • Drug: Estradiol Vaginal Tablets 10 mcg (Glenmark)
    • apply using the given applicator
  • Drug: Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)
    • apply using the given applicator
  • Drug: Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)
    • apply using the given applicator

Arms, Groups and Cohorts

  • Experimental: Estradiol Vaginal Tablets 10 mcg (Glenmark)
    • apply using the given applicator
  • Active Comparator: Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)
    • apply using the given applicator
  • Placebo Comparator: Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)
    • apply using the given applicator

Clinical Trial Outcome Measures

Primary Measures

  • The proportion of subjects with at least 25% reduction from baseline in the sum of % basal/parabasal + %intermediate cells on vaginal cytology and vaginal pH <5.0 with a change from baseline vaginal pH of at least 0.5
    • Time Frame: Day 15]

Secondary Measures

  • The proportion of subjects with treatment success at the end of study where treatment success is defined as a subject who achieves a score of 0 (none) or 1 (mild) at Visit 3/End of Study for the MBS
    • Time Frame: Day 15]

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 30 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Glenmark Pharmaceuticals Ltd. India
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dr. Nikhil Sawant, Study Director, Glenmark Pharmaceuticals Ltd.

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