Efficacy and Safety Of Spil's Estradiol Vaginal Tablet
Information source: Sun Pharmaceutical Industries Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vulvar Atrophy; Vaginal Atrophy
Intervention: Estradiol (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Sun Pharmaceutical Industries Limited
Summary
Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing
17ß-estradiol.
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.
Clinical Details
Official title: EFFICACY AND SAFETY OF SPIL'S ESTRADIOL VAGINAL TABLET, 10 MCG ESTRADIOL IN SUBJECTS WITH VULVAR AND VAGINAL ATROPHY: A RANDOMIZED, OBSERVER BLIND, PARALLEL GROUPS, ACTIVE AND PLACEBO CONTROLLED, CLINICAL ENDPOINT BIOEQUIVALENCE STUDY
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Vaginal pH
Secondary outcome: Symptoms of vulvar and vaginal atrophy
Detailed description:
Estradiol vaginal tablet is indicated for use in the treatment of symptoms of atrophic
vaginitis due to estrogen deficiency.
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Postmenopausal woman
- 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:
- Consumption of estrogen alone or estrogen/progestin containing drug products.
- Allergy to estradiol or related products
- History of breast cancer and significant risk factors for endometrial cancer
- Abnormal genital bleeding
Locations and Contacts
Biniwale Clinic Pvt. Ltd,, Pune, Maharashtra 411004, India
Additional Information
Starting date: November 2012
Last updated: May 19, 2015
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