An open-label, multiple dose, randomized, two-way crossover study to evaluate the effects of BGG492 on the pharmacokinetics and pharmacodynamics of a monophasic oral contraceptive in healthy female volunteers

An open-label, multiple dose, randomized, two-way crossover study to evaluate the effects of BGG492 on the pharmacokinetics and pharmacodynamics of a monophasic oral contraceptive in healthy female volunteers - CBGG492A2115

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34415

Enrollment

Registered

2010-08-03

Start date

2010-08-16

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

Epilepsie Epilepsia falling disease

Interventions

24 healthy female test subjects will participate in this trial. Depends on the allocation to the treatment group these 24 women will receive either 1 tablet of OC given concomitanly with 3 hard gela

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Young females, 18-40 years, BMI 18-29 kg/m2, non-smokers, OC-user

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities during screening and baseline

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics of EES and LVG on dag 14	—

Secondary

Measure	Time frame
Pharmacokinetics of EES and LVG on dag 21 PK profile of BGG492 Pharmacodynamics Safety	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)