One-sequence, two-period, open-label study to evaluate the effects of FTY720 on the pharmacokinetics of an oral contraceptive (levonorgestrel/ethinyl estradiol) in healthy female volunteers.

One-sequence, two-period, open-label study to evaluate the effects of FTY720 on the pharmacokinetics of an oral contraceptive (levonorgestrel/ethinyl estradiol) in healthy female volunteers. - FTY720D2114 OC interaction study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35177

Enrollment

Registered

2009-07-06

Start date

2009-07-14

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MS multiple sclerose

Interventions

The study (including screening and final visit) is taking place in the Xendo clinical research centre in Groningen. The study will start with a screening. A physical examination and different stand

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Female, 18-40 years of age, BMI 18-29 kg/m2, OC-user, healthy

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities during screening and baseline

Design outcomes

Primary

Measure	Time frame
The main purpose of this investigation is to examine how the new drug FTY720 (study medication) will be absorbed, metabolized and excreted by the body in combination with the contraception pill which consists of ethinyl-estradiol and levonorgestrel.	—

Secondary

Measure	Time frame
The other purposes of this investigation are: • To examine how the contraception pill, which consists of ethinyl-estradiol and levonorgestrel, will be absorbed, metabolized and excreted by the body in combination with the new drug FTY720 (study medication). • To examine the safety and tolerability of the new drug FTY720 (study medication) in combination with the contraception pill which consists of ethinyl-estradiol and levonorgestrel.	—

Measure

Time frame

The other purposes of this investigation are: • To examine how the contraception pill, which consists of ethinyl-estradiol and levonorgestrel, will be absorbed, metabolized and excreted by the body in combination with the new drug FTY720 (study medication). • To examine the safety and tolerability of the new drug FTY720 (study medication) in combination with the contraception pill which consists of ethinyl-estradiol and levonorgestrel.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)