NCT02085863

A Phase I Study in Young Healthy Women to Investigate the Effects of Laquinimod on Standard Oral Contraceptive When Both Treatments Are Given Together

A Randomized, Double-Blind, Placebo-Controlled, Two-way Crossover Drug-drug Interaction Study to Assess the Effect of Laquinimod 0.6 mg on the Pharmacokinetics and Pharmacodynamics of Ethinylestradiol and Levonorgestrel in Healthy Young Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is a single center, randomized, double blind, placebo controlled, 2-way crossover drug-drug interaction (DDI) study to assess the effect of laquinimod on the PK and PD of ethinylestradiol (EE) and levonorgestrel (LNG) a commonly used oral contraceptive combination.

Conditions

• Pharmacokinetics
• Pharmacodynamics

Interventions

Type	Name	Description
DRUG	laquinimod	Oral laquinimod 0.6 mg capsules (with oral contraceptives tablets containing 30 μg ethinylestradiol and 150 μg levonorgestrel (Microgynon®)
DRUG	Placebo	Placebo (with oral contraceptives tablets containing 30 μg ethinylestradiol and 150 μg levonorgestrel (Microgynon®)

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-09-01
• Completion: 2014-11-01
• First posted: 2014-03-13
• Last updated: 2021-11-09

Locations

1 site across 1 country: Germany