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Efficacy and Safety Of Spil's Estradiol Vaginal Tablet

Sponsor
Sun Pharmaceutical Industries Limited (Industry)
Overall Status
Terminated
CT.gov ID
NCT01753102
Collaborator
(none)
49
Enrollment
1
Location
3
Arms
5.7
Actual Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 6, 2012
Actual Primary Completion Date :
Apr 30, 2013
Actual Study Completion Date :
Apr 30, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Estradiol

Intravaginal self-administration of study medication once daily for 14 days.

Drug: Estradiol
one tablet will be inserted daily for 14 days
Other Names:
  • Vagifem

    		•
    Active Comparator: Reference: Estradiol

    Intravaginal self-administration of study medication once daily for 14 days.

    Drug: Estradiol
    one tablet will be inserted daily for 14 days
    Other Names:
  • Vagifem

    		•
    Placebo Comparator: Placebo

    Intravaginal self-administration of study medication once daily for 14 days.

    Drug: Estradiol
    one tablet will be inserted daily for 14 days
    Other Names:
  • Vagifem

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Vaginal pH [14 days]

    Secondary Outcome Measures

    1. Symptoms of vulvar and vaginal atrophy [14 days]

      Each subject will specify identified most bothersome symptoms vaginal dryness, vaginal and/or vulvar irritation/ itching, dysuria, vaginal pain associated with sexual activity, vaginal bleeding associated with sexual activity) and self-evaluate the symptom on a pre-defined scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Biniwale Clinic Pvt. Ltd, Pune Maharashtra India 411004

    Sponsors and Collaborators

    • Sun Pharmaceutical Industries Limited

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sun Pharmaceutical Industries Limited
    ClinicalTrials.gov Identifier:
    NCT01753102
    Other Study ID Numbers:
    • CLR_10_19
    • CTRI/2012/09/002983
    First Posted:
    Dec 20, 2012
    Last Update Posted:
    Oct 9, 2018
    Last Verified:
    Oct 1, 2018
    Keywords provided by Sun Pharmaceutical Industries Limited
    Estradiol
    Vulvar atrophy
    vaginal atrophy
    Additional relevant MeSH terms:
    Atrophy
    Estradiol

    Study Results

    No Results Posted as of Oct 9, 2018