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

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.

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.

Study Overview

• Status: Completed
• Conditions: Vulvar and Vaginal Atrophy
• Intervention / Treatment: Drug: Estradiol Vaginal Tablets 10 mcg (Glenmark); Drug: Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk); Drug: Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)

• Study Type: Interventional
• Enrollment (Actual): 522
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Mahwah, New Jersey, United States
      • Glenmark Pharmaceuticals Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Estradiol Vaginal Tablets 10 mcg (Glenmark); apply using the given applicator	Drug: 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	Drug: 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	Drug: Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark); apply using the given applicator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Day 15]

Secondary Outcome Measures

Outcome Measure	Time Frame
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	Day 15]

Collaborators and Investigators

• Sponsor: Glenmark Pharmaceuticals Ltd. India
• Investigators: Study Director: Dr. Nikhil Sawant, Glenmark Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): September 21, 2016
• Study Completion (Actual): September 21, 2016

Study Registration Dates

• First Submitted: January 27, 2016
• First Submitted That Met QC Criteria: January 27, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 10, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate
• Other Study ID Numbers: GLK-1502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No