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

Phase 3

Completed

• Conditions: Vulvar and Vaginal Atrophy
• Interventions: Drug: Estradiol Vaginal Tablets 10 mcg (Glenmark); Drug: Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark); Drug: Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)

• Registration Number: NCT02668796
• Lead Sponsor: Glenmark Pharmaceuticals Ltd. India

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-27
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-01-29
• Status Verified: 2016-09
• Primary Completion: 2016-09-21
• Study Completion: 2016-09-21
• Last Update Submitted: 2017-11-10
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 522

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Estradiol Vaginal Tablets 10 mcg (Glenmark)	Estradiol Vaginal Tablets 10 mcg (Glenmark)	apply using the given applicator
Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)	Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)	apply using the given applicator
Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)	Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)	apply using the given applicator

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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]

Trial Locations

Locations (1)

Glenmark Pharmaceuticals Inc.; 🇺🇸 Mahwah, New Jersey, United States