Efficacy and Safety Of Spil's Estradiol Vaginal Tablet

Sun Pharma

Status and phase: Terminated; Phase 3

Conditions: Vaginal Atrophy; Vulvar Atrophy

Treatments: Drug: Estradiol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01753102

CTRI/2012/09/002983 (Other Identifier)

CLR_10_19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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49 participants in 3 patient groups, including a placebo group

Estradiol

Experimental group

Description:

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

Treatment:

Drug: Estradiol

Reference: Estradiol

Active Comparator group

Description:

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

Treatment:

Drug: Estradiol

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Estradiol