Clinical Trial: Comparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open Randomized Two-Way Cross-Over Comparative Bioavailability Study to Compare the Extent of Systemic Absorption of Estradiol After a Single Dose Treatment With Two 25 mcg Estradiol Vaginal Tablet

Brief Summary: This trial is conducted in Europe. The aim of this trial is to compare the absorption of estradiol after a single dose of two 25 mcg estradiol vaginal tablets, produced at two different production sites, in postmenopausal women with atrophic vaginitis.

Detailed Summary:
Sponsor: Novo Nordisk A/S

Current Primary Outcome: Area under the curve (AUC(0-t)), maximal concentration (Cmax) of estradiol after baseline correction [ Time Frame: from dosing to day 4 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Number of adverse events and local tolerability [ Time Frame: from dosing to day 4 ]

Original Secondary Outcome: Same as current

Information By: Novo Nordisk A/S

Dates:
Date Received: March 11, 2010
Date Started: March 2010
Date Completion:
Last Updated: June 25, 2014
Last Verified: June 2014