Efficacy and Safety Of Spil's Estradiol Vaginal Tablet

October 6, 2018 updated by: Sun Pharmaceutical Industries Limited

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Pune, Maharashtra, India, 411004
        • Biniwale Clinic Pvt. Ltd,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vaginal pH
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms of vulvar and vaginal atrophy
Time Frame: 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
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharmaceutical Industries Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 6, 2012

Primary Completion (ACTUAL)

April 30, 2013

Study Completion (ACTUAL)

April 30, 2013

Study Registration Dates

First Submitted

December 15, 2012

First Submitted That Met QC Criteria

December 19, 2012

First Posted (ESTIMATE)

December 20, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 6, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLR_10_19
  • CTRI/2012/09/002983 (OTHER: DCGI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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