CompletedPhase 1

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

Germany42 participantsStarted 2009-12

Plain-language 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

Who can participate

Age range45 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 2 months

Trial details

NCT IDNCT01031355

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-02

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