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

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ClinicalTrials.gov Identifier: NCT02668796
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Vulvar and Vaginal Atrophy Drug: Estradiol Vaginal Tablets 10 mcg (Glenmark) Drug: Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk) Drug: Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 522 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2016
Actual Primary Completion Date : September 21, 2016
Actual Study Completion Date : September 21, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: Estradiol Vaginal Tablets 10 mcg (Glenmark)
apply using the given applicator
Drug: Estradiol Vaginal Tablets 10 mcg (Glenmark)
apply using the given applicator

Active Comparator: Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)
apply using the given applicator
Drug: Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)
apply using the given applicator

Placebo Comparator: Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)
apply using the given applicator
Drug: Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)
apply using the given applicator




Primary Outcome Measures :
  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 Outcome Measures :
  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] ]


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668796


Locations
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United States, New Jersey
Glenmark Pharmaceuticals Inc.
Mahwah, New Jersey, United States
Sponsors and Collaborators
Glenmark Pharmaceuticals Ltd. India
Investigators
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Study Director: Dr. Nikhil Sawant Glenmark Pharmaceuticals Ltd.

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Responsible Party: Glenmark Pharmaceuticals Ltd. India
ClinicalTrials.gov Identifier: NCT02668796     History of Changes
Other Study ID Numbers: GLK-1502
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Atrophy
Pathological Conditions, Anatomical
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female