NCT01031355

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

Open-label, Randomized, Cross-over Study to Investigate the Bioequivalence of Estradiol Valerate (EV) and Levomefolate Calcium After Single Oral Administration of a Tablet Formulation Containing 3 mg EV 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: 42 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Contraception
• Ovulation Inhibition

Interventions

Type	Name	Description
DRUG	Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078)	Oral, single dose, 3 mg EV + 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days
DRUG	Estradiol Valerate (EV) (BAY86-4980)	Oral, single dose, 3 mg EV, washout phase between treatments: at least 7 days
DRUG	Levomefolate Calcium (BAY86-7660)	Oral, single dose, 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-02-01
• Completion: 2010-03-01
• First posted: 2009-12-14
• Last updated: 2014-02-20

Locations

1 site across 1 country: Germany