Overview

This trial is active, not recruiting.

Condition vulvar and vaginal atrophy
Treatments estradiol vaginal tablets 10 mcg (glenmark), vagifem® (estradiol vaginal tablets) 10 mcg (novo nordisk), placebo of estradiol vaginal tablets 10 mcg (glenmark)
Phase phase 3
Sponsor Glenmark Pharmaceuticals Ltd. India
Start date January 2016
End date September 2016
Trial size 522 participants
Trial identifier NCT02668796, GLK-1502

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
apply using the given applicator
estradiol vaginal tablets 10 mcg (glenmark)
apply using the given applicator
(Active Comparator)
apply using the given applicator
vagifem® (estradiol vaginal tablets) 10 mcg (novo nordisk)
apply using the given applicator
(Placebo Comparator)
apply using the given applicator
placebo of estradiol vaginal tablets 10 mcg (glenmark)
apply using the given applicator

Primary Outcomes

Measure
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 Outcomes

Measure
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]

Eligibility Criteria

Female participants from 30 years up to 75 years old.

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.

Additional Information

Official title 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Glenmark Pharmaceuticals Ltd. India.