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Efficacy and Safety Of Spil's Estradiol Vaginal Tablet

NCT01753102 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2018-10-09

No results posted yet for this study

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.

Conditions

  • Vulvar Atrophy
  • Vaginal Atrophy

Interventions

DRUG

Estradiol

one tablet will be inserted daily for 14 days

Sponsors & Collaborators

  • Sun Pharmaceutical Industries Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-06
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01753102 on ClinicalTrials.gov