Study Results
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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TERMINATED
PHASE3
49 participants
INTERVENTIONAL
2012-11-06
2013-04-30
Brief Summary
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The estradiol in estradiol vaginal tablet is chemically and biologically identical to the endogenous human estradiol and is therefore classified as a human estrogen.
The purpose of this study is to demonstrate clinical endpoint bioequivalence of SPIL's Estradiol vaginal tablet, 10mcg estradiol to the reference listed drug (Vagifem®)which is approved and marketed in the US.
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Detailed Description
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This is a randomized, observer blind, parallel groups, active and placebo controlled study to test the clinical endpoint bioequivalence of test product (Estradiol vaginal tablet, 10mcg of Sun Pharmaceutical Industries Ltd. India) relative to reference (Vagifem®, Estradiol vaginal tablet, 10mcg estradiol of Novo Nordisk) in treatment of vulvar and vaginal atrophy.
The patients will be administered with one tablet intravaginally daily for 14 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Estradiol
Intravaginal self-administration of study medication once daily for 14 days.
Estradiol
one tablet will be inserted daily for 14 days
Reference: Estradiol
Intravaginal self-administration of study medication once daily for 14 days.
Estradiol
one tablet will be inserted daily for 14 days
Placebo
Intravaginal self-administration of study medication once daily for 14 days.
Estradiol
one tablet will be inserted daily for 14 days
Interventions
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Estradiol
one tablet will be inserted daily for 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least one subject-self-assessed moderate to severe symptom of vulvar and vaginal atrophy
* ≤ 5% superficial cells on vaginal smear cytology
* Vaginal pH \> 5.0
Exclusion Criteria
* Allergy to estradiol or related products
* History of breast cancer and significant risk factors for endometrial cancer
* Abnormal genital bleeding
FEMALE
No
Sponsors
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Sun Pharmaceutical Industries Limited
INDUSTRY
Responsible Party
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Locations
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Biniwale Clinic Pvt. Ltd,
Pune, Maharashtra, India
Countries
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Other Identifiers
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CTRI/2012/09/002983
Identifier Type: OTHER
Identifier Source: secondary_id
CLR_10_19
Identifier Type: -
Identifier Source: org_study_id
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