A Randomised, Double-Blind, Placebo-Controlled, Two-Sequence, Two-Period, Crossover Study to Evaluate the Effect of SMP-028 on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

A Randomised, Double-Blind, Placebo-Controlled, Two-Sequence, Two-Period, Crossover Study to Evaluate the Effect of SMP-028 on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects - OC interaction study with SMP-028

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34656

Enrollment

Registered

2009-12-24

Start date

2010-01-14

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

asthma chronic inflammation of the lungs

Interventions

The study will start with a screening. A physical examination and different standard test (ECG, blood pressure) will be performed during the screening appointment. Also a cervical smear and an vagin

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy females 18-45 year

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities for medical examination

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics Microgynon	—

Secondary

Measure	Time frame
Pharmacokinetics SMP-028 Pharmacodynamics Safety and tolerability	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)