Trial Condition(s):
Contraception, Ovulation inhibition
Bioequivalence study: 3 mg Estradiol Valerate (EV) with and without levomefolate calcium
Bayer Identifier:
13468
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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
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 Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Nuvisan GmbH Neu-Ulm, Germany, 89231 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Open-label, randomized, cross-over study to investigate the bioequivalence of estradiol valerate (EV) and levomefolate calcium after single oral administration of a tablet formulation containing 3 mg EV without and with 0.451 mg levomefolate calcium and a tablet formulation containing 0.451 mg levomefolate calcium in 42 healthy postmenopausal women
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
3
Primary Outcome
- Uncorrected Cmax and AUC(0-tlast) and baseline corrected Cmax and AUC (if possible) for E1, E2, E1S, and L-5- methyl-THFTimeframe: 2 months
Additional Information
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