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Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: YAZ and YAZ + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and YAZ + Levomefolate Calcium (Metafolin)

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300) (Drug); EE 0.02 mg/DRSP 3 mg/L-5-MTHF Ca 0.451 mg (EE20/DRSP/L-5-MTHF Ca) (Drug); L-5-MTHF 0.451mg (Metafolin) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

The purpose of this study is examine and compare the uptake of YAZ (oral contraceptive containing drospirenone and ethinylestradiol) with or without levomefolate calcium (Metafolin, a registered vitamin supplement) in the body and to examine and compare the uptake of levomefolate calcium with or without YAZ in the body, in healthy volunteers not using hormonal contraception

Clinical Details

Official title: Open-label, Randomized, Three-fold Crossover Study to Investigate the Bioequivalence of Two Different Tablet Formulations Containing 0.02 mg Ethinylestradiol (EE) and 3 mg Drospirenone (DRSP) Without [SH T00186D] and With [SH T04532B] 0.451 mg L-mefolinate (Metafolin), and to Investigate the Bioequivalence of Two Different Tablet Formulations Containing 0.451 mg L-mefolinate (Metafolin) Without [SH T04532C] and With 0.02 mg EE/ 3 mg DRSP [SH T04532B] in 42 Healthy Young Women

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Mean Maximum Concentration (Cmax) of EE Incl. Bioequivalence (BE) Evaluation

Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of EE Incl. Bioequivalence (BE) Evaluation

Mean Maximum Concentration (Cmax) of DRSP Incl. Bioequivalence (BE) Evaluation

Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of DRSP Incl. Bioequivalence (BE) Evaluation

Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation

Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation

Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation

Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation

Secondary outcome:

Time to Reach Maximum Concentration (Tmax) of EE

Mean Area Under the Concentration-time Curve From Administration up to 72h AUC(0-72h) of DRSP

Time to Reach Maximum Concentration (Tmax) of DRSP

Time to Reach Maximum Concentration (Tmax) of L-5-methyl-THF

Eligibility

Minimum age: 18 Years. Maximum age: 38 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Healthy female volunteer

- Age: 18 - 38 years inclusive

- Body mass index (BMI)1: ≥ 19 and < 28 kg/m²

- Regular cyclic menstrual periods at screening OR when using combined oral

contraceptives during the recruitment period reporting of natural cyclic menstrual periods prior to their use

- Willingness to use non-hormonal methods of contraception during the complete trial OR

previous tubal ligation Exclusion Criteria:

- incompletely cured pre-existing diseases for which it can be assumed that the

absorption, distribution, metabolism, excretion and effect of the study drugs will not be normal

- known or suspected sex-steroid influenced malignancies

- endometrial hyperplasia; genital bleeding of unknown origin; uterus myomatosus

- known or suspected tumors of the liver and pituitary

- presence or history of severe hepatic disease as long as liver function values have

not returned to normal

- severe renal insufficiency or acute renal failure

- thrombophlebitis, venous / arterial thromboembolic diseases; presence or history of

prodromi of a thrombosis

- other conditions that increase susceptibility to thromboembolic diseases

- known neuropsychiatric diseases, especially known or suspected epilepsy, and/ or

deficient status of folate or vitamin B12

- use of any other medication within 2 cycles before first study drug administration

which could affect the study aim

- use of potassium sparing drugs; use of folic acid containing supplements or medicines

or use of any medication within 2 cycles before first study drug administration known to interfere with folate metabolism

- inadequate folate and/or Vitamin B12 status, clinically relevant deviations in red

cell folate concentrations

Locations and Contacts

Dinox B.V., Groningen 9713GZ, Netherlands
Additional Information

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Starting date: October 2006
Last updated: August 1, 2013

Page last updated: August 23, 2015

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