Bioequivalence Study: 2 mg Estradiol Valerate (EV) and 3 mg Dienogest (DNG) Without and With Levomefolate Calcium
Information source: Bayer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception; Ovulation Inhibition; Contraceptives, Oral
Intervention: BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium (Drug); BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG) (Drug); BAY 86-7660,levomefolate calcium (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Summary
Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) and Dienogest (DNG)
after administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg
Dienogest and 0. 451 mg Levomefolate calcium as compared to one film-coated tablet containing
2 mg Estradiol Valerate,3 mg Dienogest.
Investigation of the bioequivalence of levomefolate calcium after administration of one
film-coated tablet containing 2 mg Estradiol Valerate, 3 mg Dienogest and 0. 451 mg
Levomefolate calcium as compared to one film-coated tablet containing 0. 451 mg levomefolate
calcium
Clinical Details
Official title: Open-label, Randomized, Cross-over Study to Investigate the Bioequivalence of Estradiol Valerate (EV), Dienogest (DNG) and Levomefolate Calcium After Single Oral Administration of a Tablet Formulation Containing 2 mg Estradiol Valerate and 3 mg Dienogest Without and With 0.451 mg Levomefolate Calcium and a Tablet Formulation Containing 0.451 mg Levomefolate Calcium in 42 Healthy Postmenopausal Women
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Primary outcome: Cmax and AUC (if possible) of DNG as well as uncorrected Cmax and AUC(0-tlast) and baseline corrected Cmax and AUC (if possible) for E1, E2, E1S, and L-5- methyl-THF
Eligibility
Minimum age: 45 Years.
Maximum age: 75 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Signed Informed Consent
- BMI:>18 <30 kg/m²
- Healthy female volunteers
- Age 45-75 years
- Postmenopausal state
Exclusion Criteria:
- Contraindications for use of combined (Estradiolvalerate/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
Locations and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Neu-Ulm, Bayern 89231, Germany; Recruiting
Additional Information
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Starting date: October 2009
Ending date: December 2009
Last updated: October 9, 2009
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