NCT03745144 - Effects of Cladribine Tablets on the PK of Microgynon® | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 17, 2019

Primary Completion Date

September 2, 2022

Study Completion Date

September 16, 2022

Conditions

Relapsing Multiple Sclerosis (RMS)

Interventions

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.

Trial Locations (7)

Unknown

St. Josef und St. Elisabeth Hospital gGmbH, Bochum

Nuvisan GmbH, Neu-Ulm

M.A. - LEK A.M.Maciejowscy SC., Katowice

BioResearch Group Sp. z o. o, Nadarzyn

IKARDIA Hospital Cardiology, Nałęczów

BioVirtus Research Site Sp, Otwock

MTZ Clinical Research Sp. z o.o., Warsaw

All Listed Sponsors

lead

Merck KGaA, Darmstadt, Germany

INDUSTRY