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.
1 other identifier
interventional
522
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2016
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 27, 2016
CompletedFirst Posted
Study publicly available on registry
January 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2016
CompletedNovember 14, 2017
September 1, 2016
9 months
January 27, 2016
November 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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]
Study Arms (3)
Estradiol Vaginal Tablets 10 mcg (Glenmark)
EXPERIMENTALapply using the given applicator
Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)
ACTIVE COMPARATORapply using the given applicator
Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)
PLACEBO COMPARATORapply using the given applicator
Interventions
apply using the given applicator
apply using the given applicator
apply using the given applicator
Eligibility Criteria
You may qualify if:
- Female postmenopausal subjects aged \>30 to \<75 years
- 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
- Have \<5% superficial cells on vaginal smear cytology and vaginal pH \>5.0 at Visit 1
- Systolic blood pressure \<150mm Hg and diastolic blood pressure \<90mm Hg at Visit 1
You may not qualify if:
- Known hypersensitivity to Estradiol vaginal tablet
- Screening mammogram or clinical breast examination results indicating any suspicion of breast malignancy.
- History of undiagnosed vaginal bleeding.
- History of significant risk factors for endometrial cancer
- For women with an intact uterus, screening vaginal ultrasonography showing endometrial thickness of ≥ 4 mm.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Glenmark Pharmaceuticals Inc.
Mahwah, New Jersey, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr. Nikhil Sawant
Glenmark Pharmaceuticals Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2016
First Posted
January 29, 2016
Study Start
January 1, 2016
Primary Completion
September 21, 2016
Study Completion
September 21, 2016
Last Updated
November 14, 2017
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share