Efficacy and Safety Of Spil's Estradiol Vaginal Tablet

Vaginal Atrophy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01753102
• Other study ID #: CLR_10_19
• Secondary ID: CTRI/2012/09/002
• Status: Terminated
• Phase: Phase 3
• Start date: November 6, 2012
• Est. completion date: April 30, 2013

Study information

• Verified date: October 2018
• Source: Sun Pharmaceutical Industries Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: April 30, 2013
• Est. primary completion date: April 30, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Vaginal Atrophy
• Vulvar Atrophy

Intervention

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

Locations

Country	Name	City	State
India	Biniwale Clinic Pvt. Ltd,	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal pH		14 days
Secondary	Symptoms of vulvar and vaginal atrophy	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