Who is sponsoring NCT01258660?

NCT01258660 is sponsored by Bayer.

What condition does NCT01258660 study?

NCT01258660 studies Contraception.

What drugs are being tested in NCT01258660?

Interventions: EE 0.03 mg/DRSP 3 mg/Metafolin + folic acid placebo, EE 0.03 mg/DRSP 3 mg (Yasmin) + folic acid.

What is the status of NCT01258660?

NCT01258660 is currently COMPLETED.

Last reviewed 2013-09-15 · How we verify

A Randomized, Double-blind, Double-dummy, 2-parallel Arms Clinical Trial to Assess the Pharmacodynamic Effect on Plasma Folate and Red Blood Cell Folate and to Compare the Profile of Circulating Folate Metabolites During 24 Weeks of Treatment With an Oral Contraceptive Containing Ethinylestradiol, Drospirenone and L-5-methyltetrahydrofolate (SH T04532A and SH T04532C) or Yasmin (SH T04532D and SH T04532PC) Co-administered With Folic Acid (SH K04532B) Followed by 20 Weeks of Open-label Treatment With Yasmin Only (Folate Elimination Phase) in Women Seeking Contraception

NCT01258660 Phase 1 COMPLETED Results posted

The purpose of this study is to examine and compare the uptake of levomefolate calcium (Metafolin, a registered vitamin supplement) and folic acid in the body during 24 weeks of treatment with a following folate elimination phase of 20 weeks in healthy volunteers seeking contraception. Yasmin (oral contraceptive containing drospirenone and ethinylestradiol) was co-administered over the entire period of 44 weeks.

Details

Lead sponsor	Bayer
Phase	Phase 1
Status	COMPLETED
Enrolment	172
Start date	2006-12
Completion	2008-01

Conditions

Contraception

Interventions

EE 0.03 mg/DRSP 3 mg/Metafolin + folic acid placebo
EE 0.03 mg/DRSP 3 mg (Yasmin) + folic acid

Primary outcomes

Area Under the Curve (AUC) From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Uncorrected) — up to 24 weeks of treatment
The Area under the curve (AUC) is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Area Under the Curve From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Corrected) — up to 24 weeks of treatment
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44) — from week 24 to week 44
Proportion of participants with RBC folate below 906 nmol/L in the Yasmin + Metafolin group in the folate elimination phase (week 24 to 44)

Countries

Germany