An open-label, multiple-dose, sequential, 2 treatment period study to evaluate the effect of QBW251 on the pharmacokinetics and pharmacodynamics of a monophasic oral contraceptive in pre-menopausal healthy female volunteers

An open-label, multiple-dose, sequential, 2 treatment period study to evaluate the effect of QBW251 on the pharmacokinetics and pharmacodynamics of a monophasic oral contraceptive in pre-menopausal healthy female volunteers - CQBW251X22102 (CS0216)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40637

Enrollment

Registered

2014-05-06

Start date

2015-05-21

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

CF mucoviscidosis

Interventions

The study will start with a screening visit. During the screening visit standard medical assessments including safety laboratory tests (blood draw, urine collection), an alcohol breath test, urine d

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy premenopausal female subjects age 18 to 50 years of age. Stable regimen of monophasic OC containing EE (30 µg)/LVG (150 µg) for at least three cycles prior to dosing in treatment period.;Any Subject not taking any OC or taking another brand of;monophasic OC (which does not contain 30 µg EE and 150 µg LVG);should be willing to take a monophasic OC containing 30 µg EE and;150 µg LVG for at least three cycles during synchronization until day -7.;Negative pregnancy test results at screening and both baseline;visits.

Exclusion criteria

Exclusion criteria: Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations.;Women of child-bearing potential, defined as all women;physiologically capable of becoming pregnant, unless they are using contraception methods.;Women who are either heterozygous or homozygous for the Factor V Leiden mutation.

Design outcomes

Primary

Measure	Time frame
Confirmatory PK PD	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)