drugset / Trial / NCT00465192

Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis

NCT00465192 ↗

Phase 3 Completed 230 enrolled Novo Nordisk A/S
RandomizedParallel-groupDouble-blindTreatment

Summary

This trial was conducted in the United States of America (USA). This trial aimed for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.

Timeline

Start
1994-08-31
Primary completion
1995-11-30
Completion
1995-11-30

Outcome

Met primary endpoint

paper Vaginal tablets with 25 mcg and 10 mcg E2 showed significant (P<.001) improvement in composite score of vaginal health. PMID 18165394 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Estradiol Other / unclassified 10 ug Other
Subject Estradiol Other / unclassified 25 ug Other