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

Bayer42 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Contraception Ovulation Inhibition

Interventions

Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078)DRUG

Oral, single dose, 3 mg EV + 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days

Estradiol Valerate (EV) (BAY86-4980)DRUG

Oral, single dose, 3 mg EV, washout phase between treatments: at least 7 days

Levomefolate Calcium (BAY86-7660)DRUG

Oral, single dose, 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * BMI:\>18 \<30 kg/m² * Healthy female volunteers * Age 45-75 years * Postmenopausal state Exclusion Criteria: * Contraindications for use of combined (Estradiol Valerate/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

Locations (1)

Unnamed facility

Neu-Ulm, Bavaria, Germany

Outcomes

Primary Outcomes

Uncorrected Cmax and AUC(0-tlast) and baseline corrected Cmax and AUC (if possible) for E1, E2, E1S, and L-5- methyl-THF

Time frame: 2 months

Data from ClinicalTrials.gov

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