Clinical Trial: Pharmacokinetic Assessment of the Absorption of Estradiol in Postmenopausal Women With Atrophic Vaginitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Pharmacokinetic Randomized Study With a Parallel Group Design to Assess the Extent of Systemic Absorption of Estradiol During Treatment With a 10 µg or 25 µg Estradiol Vaginal Tablet Admin
Brief Summary: This trial is conducted in Europe. The aim of this trial is to to evaluate the extent of systemic absorption of estradiol during treatment with two different doses of estradiol in postmenopausal women with atrophic vaginitis.
Detailed Summary:
Sponsor: Novo Nordisk A/S
Current Primary Outcome: Area under the curve (AUC)
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Average plasma concentration (C average)
- Maximal concentration (Cmax)
- Minimal concentration (Cmin)
- Time of maximal concentration (tmax)
- Incidence of adverse events
Original Secondary Outcome: Same as current
Information By: Novo Nordisk A/S
Dates:
Date Received: December 5, 2011
Date Started: January 2007
Date Completion:
Last Updated: February 6, 2017
Last Verified: February 2017
