NCT01085877

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

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 Formulations Administered in Postmenopausal Women With Vaginal Atrophy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Female
• Age: 55 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Menopause
• Postmenopausal Vaginal Atrophy

Interventions

Type	Name	Description
DRUG	estradiol, 25 mcg	Single dose of vaginal tablet containing 25 mcg estradiol (Production site A) followed by another single dose of vaginal tablet containing 25 mcg estradiol (Production site B)
DRUG	estradiol, 25 mcg	Single dose of vaginal tablet containing 25 mcg estradiol (Production site B) followed by another single dose of vaginal tablet containing 25 mcg estradiol (Production site A)

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2010-03-12
• Last updated: 2014-06-26

Locations

1 site across 1 country: Germany