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

Phase 1

Completed

• Conditions: Pharmacology, Clinical
• Interventions: Drug: BAY 86-7660,levomefolate calcium; Drug: BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG); Drug: BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium

• Registration Number: NCT00941057
• Lead Sponsor: Bayer

Brief 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-07-16
• Study First Submitted QC: 2009-07-16
• Study First Posted: 2009-07-17
• Study Start: 2009-09
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-29
• Last Update Posted: 2016-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

Inclusion Criteria

• Healthy postmenopausal women, age: 45-75 years with body mass index between ≥18 and ≤30 kg/m2. Post-menopausal state revealed by: medical history, and hormone analyses in serum: estradiol ≤20 pg/mL and in women <60 years old: follicle-stimulating hormone ≥ 40 IU/L at screening

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Exclusion Criteria

• Contraindications for use of combined (Estradiolvalerate/Dienogest) contraceptive (e.g.history of venous/arterial thromboembolic disease)
• Regular intake of medication
• Clinically relevant findings (ECG, blood pressure, physical and gynaecological examination, laboratory examination)
• Smoking

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Levomefolate	BAY 86-7660,levomefolate calcium	Treatment C
Estradiol + dienogest	BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG)	Treatment B
Estradiol + dienogest + levomefolate	BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium	Treatment A

Primary Outcome Measures

Name	Time	Method
AUC	Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C	Area under the concentration vs time curve from zero to infinity for DNG
Cmax	Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C	Maximum drug concentration for DNG and for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected)
AUC(0-tlast)	Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C	AUC from time 0 to the last data point above the lower limit of quantitation for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected)

Secondary Outcome Measures

Name	Time	Method
tmax	Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C	Time to reach maximum drug concentration in plasma for DNG and E1, E2, E1S, and L-5-methyl-THF (baseline uncorrected)
t½	Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C	Half-life associated with the terminal slope for DNG and E1, E2, E1S, and L-5-methyl-THF
λz	Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C	Apparent terminal rate constant(estimates only) for DNG and E1, E2, E1S, and L-5-methyl-THF
AUC(0-tlast)	Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C	AUC from time 0 to the last data point above the lower limit of quantitation for DNG
AUC	Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C	Area under the concentration vs time curve from zero to infinity E1, E2, E1S, and L-5-methyl-THF (baseline corrected)