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

Bayer

Status and phase: Completed; Phase 1

Conditions: Contraception; Ovulation Inhibition

Treatments: Drug: Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078); Drug: Levomefolate Calcium (BAY86-7660); Drug: Estradiol Valerate (EV) (BAY86-4980)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01031355

13468

2009-011962-27 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: Female

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

Arm 1

Experimental group

Treatment:

Drug: Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078)

Arm 2

Active Comparator group

Treatment:

Drug: Estradiol Valerate (EV) (BAY86-4980)

Arm 3

Active Comparator group

Treatment:

Drug: Levomefolate Calcium (BAY86-7660)