A single dose, randomized, three arm, two-way, cross-over study to assess the effect of food on the pharmacokinetics of the commercial NOMAC-E2 tablet formulation and of the phase 3 pivotal clinical batches (Protocol No. P06456)

Completed

• Conditions: Gecombineerde orale hormonale anticonceptie; birth control; Contraceptive

• Registration Number: NL-OMON35968
• Lead Sponsor: Schering-Plough

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Healthy postmenopausal females
Age : 45-70 years, inclusive
BMI : 18 - 32, inclusive

Exclusion Criteria

Suffering from : hepatitis B, cancer or HIV-Aids. In case of participation in more then two other drug study within 60 days before the start of the study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.0 liters of blood in the 10 months preceding the start of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Pharmacokinetics<br /><br>- Safety</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.a.</p><br>