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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-01-31

Brief Summary

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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

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Detailed Description

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Conditions

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Pharmacology, Clinical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Estradiol + dienogest + levomefolate

Treatment A

Group Type EXPERIMENTAL

BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium

Intervention Type DRUG

Oral, single dose, 2 mg EV + 3 mg DNG + 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days

Estradiol + dienogest

Treatment B

Group Type ACTIVE_COMPARATOR

BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG)

Intervention Type DRUG

Oral, single dose, 2 mg EV + 3 mg DNG washout phase between treatments: at least 7 days

Levomefolate

Treatment C

Group Type ACTIVE_COMPARATOR

BAY 86-7660,levomefolate calcium

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

BAY 86-7660,levomefolate calcium

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

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes