Bioequivalence Study: 3 mg Estradiol Valerate (EV) With and Without Levomefolate Calcium
Phase 1
Completed
- Conditions
- Ovulation InhibitionContraception
- Interventions
- Registration Number
- NCT01031355
- Lead Sponsor
- Bayer
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 42
Inclusion Criteria
- BMI:>18 <30 kg/m²
- Healthy female volunteers
- Age 45-75 years
- Postmenopausal state
Read More
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
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 3 Levomefolate Calcium (BAY86-7660) - Arm 2 Estradiol Valerate (EV) (BAY86-4980) - Arm 1 Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078) -
- Primary Outcome Measures
Name Time Method Uncorrected Cmax and AUC(0-tlast) and baseline corrected Cmax and AUC (if possible) for E1, E2, E1S, and L-5- methyl-THF 2 months
- Secondary Outcome Measures
Name Time Method