NCT03745144

Effects of Cladribine Tablets on the PK of Microgynon®

A Randomized, Double-blind, 2-Period, 2-Sequence Crossover Phase I Study With a 1 Month run-in Period to Examine the Effect of Cladribine Tablets on the PK of a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel (Microgynon®) in Pre-Menopausal Women With RMS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to investigate the potential effects of cladribine on the pharmacokinetics (PK) of monophasic oral contraceptive microgynon® by assessment of its constituents, ethinyl estradiol (EE) and levonorgestrel (LNG).

Conditions

• Relapsing Multiple Sclerosis (RMS)

Interventions

Type	Name	Description
DRUG	Cladribine	Participants received cladribine once-daily for 5 consecutive days in treatment period 1 and 2.
DRUG	Placebo	Participants received placebo matched to cladribine once-daily for 5 consecutive days in treatment period 1 and 2.
DRUG	Microgynon®	Participants received Microgynon® tablet once daily for 21 days in treatment period 1 and 2. Participants received Microgynon® for 21 days, starting on the first day of the menstrual cycle in Run-in period.

Timeline

• Start date: 2019-01-17
• Primary completion: 2022-09-02
• Completion: 2022-09-16
• First posted: 2018-11-19
• Last updated: 2024-03-15
• Results posted: 2024-03-15

Locations

7 sites across 2 countries: Germany, Poland