An open-label, multiple-dose, two-treatment period study to evaluate the effect of oral BAF312 on the pharmacokinetics and pharmacodynamics of a monophasic oral contraceptive in healthy female volunteers.

Completed

• Conditions: MS; Multiple Sclerosis; 10003816

• Registration Number: NL-OMON37415
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

Woman between the ages of 18 and 40 years and a non-smoker. BMI between 18
and 30, with a minimum weight of 50 kg.

Exclusion Criteria

Clinical significant abnormalities at medical research

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To investigate whether BAF312 administered daily at a dose of 4 mg can affect<br /><br>exposure (Cmax and AUC) to a daily administered monophasic oral contraceptive<br /><br>(OC) regimen containing 30 µg of ethinylestradiol (EE) and 150 µg of<br /><br>levonorgestrel (LVG).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To assess the effect of oral BAF312 (4 mg q.d.) on the pharmacodynamics of a<br /><br>monophasic OC determined by Hoogland score, FSH, LH, estradiol,<br /><br>progesterone,SHBG concentrations and ovarian follicle size<br /><br>- To assess the safety and tolerability of oral BAF312 (4 mg q.d.) in<br /><br>co-administration with a monophasic OC,<br /><br>- To assess the PK profile of oral BAF312 (4 mg q.d.) when combined with a<br /><br>daily administered monophasic oral contraceptive (OC) regimen containing 30 µg<br /><br>of EE and 150 µg of LVG.</p><br>