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

Primary Purpose

Vulvar and Vaginal Atrophy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Estradiol Vaginal Tablets 10 mcg (Glenmark)
Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)
Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)
Sponsored by
Glenmark Pharmaceuticals Ltd. India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvar and Vaginal Atrophy

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Glenmark Pharmaceuticals Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Estradiol Vaginal Tablets 10 mcg (Glenmark)

Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)

Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)

Arm Description

apply using the given applicator

apply using the given applicator

apply using the given applicator

Outcomes

Primary Outcome 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

Secondary Outcome 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

Full Information

First Posted
January 27, 2016
Last Updated
November 10, 2017
Sponsor
Glenmark Pharmaceuticals Ltd. India
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1. Study Identification

Unique Protocol Identification Number
NCT02668796
Brief Title
To Study Generic Estradiol 10 mcg Vaginal Tablets in the Treatment of Vulvar and Vaginal Atrophy in Post Menopausal Women.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 21, 2016 (Actual)
Study Completion Date
September 21, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glenmark Pharmaceuticals Ltd. India

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar and Vaginal Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
522 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Estradiol Vaginal Tablets 10 mcg (Glenmark)
Arm Type
Experimental
Arm Description
apply using the given applicator
Arm Title
Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)
Arm Type
Active Comparator
Arm Description
apply using the given applicator
Arm Title
Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)
Arm Type
Placebo Comparator
Arm Description
apply using the given applicator
Intervention Type
Drug
Intervention Name(s)
Estradiol Vaginal Tablets 10 mcg (Glenmark)
Intervention Description
apply using the given applicator
Intervention Type
Drug
Intervention Name(s)
Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)
Intervention Description
apply using the given applicator
Intervention Type
Drug
Intervention Name(s)
Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)
Intervention Description
apply using the given applicator
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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]

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Nikhil Sawant
Organizational Affiliation
Glenmark Pharmaceuticals Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Glenmark Pharmaceuticals Inc.
City
Mahwah
State/Province
New Jersey
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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