Study Completed

Contraception

Bayer Identifier:

91460

ClinicalTrials.gov Identifier:

NCT01253187

EudraCT Number:

2005-003049-15

EU CT Number:

Not Available

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)

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

18 - 38 Years

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

Trial summary

Enrollment Goal

Trial Dates

October 2006 - September 2007

Phase

Phase 1

Could I Receive a placebo

Products

EE/DRSP/L-5-MTHF (BAY86-5131)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Dinox B.V.	Groningen, 9713GZ, Netherlands

Primary Outcome

Mean maximum concentration (Cmax) of EE incl. bioequivalence (BE) evaluation
Time Frame:
up to 96 hours after administration
Safety Issue:
No
Mean Area Under the concentration-time Curve from administration to the last measurement [AUC(0-tlast)] of EE incl. bioequivalence (BE) evaluation
Time Frame:
up to 96 hours after administration
Safety Issue:
No
Mean maximum concentration (Cmax) of DRSP incl. bioequivalence (BE) evaluation
Time Frame:
up to 168 hours after administration
Safety Issue:
No
Mean Area Under the concentration-time Curve from administration to the last measurement [AUC(0-tlast)] of DRSP incl. bioequivalence (BE) evaluation
Time Frame:
up to 168 hours after administration
Safety Issue:
No
Mean maximum concentration (Cmax) of L-5-methyl-THF (baseline corrected) incl. bioequivalence (BE) evaluation
Time Frame:
up to 12 hours after administration
Safety Issue:
No
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
Time Frame:
up to 12 hours after administration
Safety Issue:
No
Mean maximum concentration (Cmax) of L-5-methyl-THF (baseline uncorrected) incl. bioequivalence (BE) evaluation
Time Frame:
up to 12 hours after administration
Safety Issue:
No
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
Time Frame:
up to 12 hours after administration
Safety Issue:
No

Secondary Outcome

Time to reach maximum concentration (tmax) of EE
Time Frame:
up to 96 hours after administration
Safety Issue:
No
Mean Area Under the concentration-time Curve from administration up to 72h AUC(0-72h) of DRSP
Time Frame:
up to 72 hours after administration
Safety Issue:
No
Time to reach maximum concentration (tmax) of DRSP
Time Frame:
up to 168 hours after administration
Safety Issue:
No
Time to reach maximum concentration (tmax) of L-5-methyl-THF
Time Frame:
up to 12 hours after administration
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Open Label

Assignment

Crossover Assignment

Trial Arms

Additional Information

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