NCT00941057

Bioequivalence Study: 2 mg Estradiol Valerate (EV) and 3 mg Dienogest (DNG) Without and With Levomefolate Calcium

Open-label, Randomized, Cross-over Study to Investigate the Bioequivalence of Estradiol Valerate (EV), Dienogest (DNG) and Levomefolate Calcium After Single Oral Administration of a Tablet Formulation Containing 2 mg Estradiol Valerate and 3 mg Dienogest Without and With 0.451 mg Levomefolate Calcium and a Tablet Formulation Containing 0.451 mg Levomefolate Calcium in 42 Healthy Postmenopausal Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) and Dienogest (DNG) after administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg Dienogest and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 2 mg Estradiol Valerate,3 mg Dienogest.Investigation of the bioequivalence of levomefolate calcium after administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg Dienogest and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 0.451 mg levomefolate calcium

Conditions

• Pharmacology, Clinical

Interventions

Type	Name	Description
DRUG	BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium	Oral, single dose, 2 mg EV + 3 mg DNG + 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days
DRUG	BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG)	Oral, single dose, 2 mg EV + 3 mg DNG washout phase between treatments: at least 7 days
DRUG	BAY 86-7660,levomefolate calcium	Oral, single dose, 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2009-07-17
• Last updated: 2016-08-01

Locations

1 site across 1 country: Germany