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

NCT ID: NCT02668796

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

522 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-09-21

Brief Summary

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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.

Detailed Description

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Conditions

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Vulvar and Vaginal Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Estradiol Vaginal Tablets 10 mcg (Glenmark)

apply using the given applicator

Group Type EXPERIMENTAL

Estradiol Vaginal Tablets 10 mcg (Glenmark)

Intervention Type DRUG

apply using the given applicator

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

apply using the given applicator

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

apply using the given applicator

Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)

apply using the given applicator

Group Type PLACEBO_COMPARATOR

Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)

Intervention Type DRUG

apply using the given applicator

Interventions

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Estradiol Vaginal Tablets 10 mcg (Glenmark)

apply using the given applicator

Intervention Type DRUG

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

apply using the given applicator

Intervention Type DRUG

Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)

apply using the given applicator

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Glenmark Pharmaceuticals Ltd. India

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Nikhil Sawant

Role: STUDY_DIRECTOR

Glenmark Pharmaceuticals Ltd.

Locations

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Glenmark Pharmaceuticals Inc.

Mahwah, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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GLK-1502

Identifier Type: -

Identifier Source: org_study_id