NCT01486979

Pharmacokinetic Assessment of the Absorption of Estradiol in Postmenopausal Women With Atrophic Vaginitis

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 Administered Once Daily for 2 Weeks Followed by 10 Weeks of Twice-Weekly Maintenance Therapy in Postmenopausal Women With Atrophic Vaginitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Female
• Age: 60 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Menopause
• Postmenopausal Vaginal Atrophy

Interventions

Type	Name	Description
DRUG	estradiol, 10 mcg	One vaginal tablet once daily in the morning during the first two weeks of treatment followed by one vaginal tablet twice weekly in the morning for 10 weeks
DRUG	estradiol, 25 mcg	One vaginal tablet once daily in the morning during the first two weeks of treatment followed by one vaginal tablet twice weekly in the morning for 10 weeks

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2011-12-07
• Last updated: 2017-02-08

Locations

1 site across 1 country: Germany