TerminatedPhase 3

Efficacy and Safety Of Spil's Estradiol Vaginal Tablet

Stopped: Slow recruitment

India49 participantsStarted 2012-11-06

Plain-language 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.

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Vaginal pH

Timeframe: 14 days

Trial details

NCT IDNCT01753102

SponsorSun Pharmaceutical Industries Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-04-30

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