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OpenTrials
Completed

NCT Number: NCT02668796

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

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.

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Key information

Conditions

Vulvar and Vaginal Atrophy

Age range

30 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Glenmark Pharmaceuticals Inc.

Mahwah, New Jersey, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Estradiol Vaginal Tablets 10 mcg (Glenmark)

Drug

apply using the given applicator

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

Drug

apply using the given applicator

Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)

Drug

apply using the given applicator

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

    Time frame: 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

    Time frame: Day 15]

Sponsors and collaborators

Lead sponsor

Glenmark Pharmaceuticals Ltd. India

Industry

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 29, 2016
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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