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

Vulvar and Vaginal Atrophy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668796
• Other study ID #: GLK-1502
• Status: Completed
• Phase: Phase 3
• First received: January 27, 2016
• Last updated: November 10, 2017
• Start date: January 2016
• Est. completion date: September 21, 2016

Study information

• Verified date: September 2016
• Source: Glenmark Pharmaceuticals Ltd. India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 522
• Est. completion date: September 21, 2016
• Est. primary completion date: September 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Vulvar and Vaginal Atrophy

Intervention

Drug:
• Estradiol Vaginal Tablets 10 mcg (Glenmark)
apply using the given applicator
• Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)
apply using the given applicator
• Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)
apply using the given applicator

Locations

Country	Name	City	State
United States	Glenmark Pharmaceuticals Inc.	Mahwah	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Glenmark Pharmaceuticals Ltd. India

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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]