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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
First received
Last updated
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
Health authority
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 (VagifemĀ®, 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

Study Design


Related Conditions & MeSH terms


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
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