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

Official Title: “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”

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

Intervention(s) in this Clinical Trial

• Drug: Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078)
  • Oral, single dose, 3 mg EV + 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days
• Drug: Estradiol Valerate (EV) (BAY86-4980)
  • Oral, single dose, 3 mg EV, washout phase between treatments: at least 7 days
• Drug: Levomefolate Calcium (BAY86-7660)
  • Oral, single dose, 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Active Comparator: Arm 2
• Active Comparator: Arm 3

Primary Measures

• Uncorrected Cmax and AUC(0-tlast) and baseline corrected Cmax and AUC (if possible) for E1, E2, E1S, and L-5- methyl-THF
  • Time Frame: 2 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Bayer Industry

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01031355

Study ID Number: 13468

ClinicalTrials.gov Identifier: NCT01031355

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.