Effects of Cladribine Tablets on the PK of Microgynon®

Merck KGaA, Darmstadt, Germany28 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Relapsing Multiple Sclerosis (RMS)

Interventions

CladribineDRUG

Participants received cladribine once-daily for 5 consecutive days in treatment period 1 and 2.

PlaceboDRUG

Participants received placebo matched to cladribine once-daily for 5 consecutive days in treatment period 1 and 2.

Microgynon®DRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Are pre-menopausal women with or without child-bearing potential with a negative serum pregnancy test, and women with child-bearing potential receiving adequate birth control * Participants with diagnosis of clinically stable and definite relapsing multiple sclerosis (RMS) * Adequate hematological, hepatic and renal function as defined in the protocol * Are able and willing to accept dietary restrictions and restrictions regarding the use of concomitant medications (including over-the-counter products, herbal medicines and dietary supplements) over the course of the study * Had a body weight and body mass index (BMI) within the range at screening * Other protocol defined inclusion criteria could apply Exclusion Criteria: * History of clinically relevant allergy or known hypersensitivity to the active substance or to any of the excipients of cladribine tablets or hypersensitivity to drugs with a similar chemical structure to cladribine - History of clinically relevant allergy or known hypersensitivity to 1 of the active substances levonorgestrel (LNG) or ethinylestradiol (EE) or to any excipients of Microgynon® tablets * Positive results from serology examination for Hepatitis B surface antigen (HbsAg) not due to vaccination, hepatitis B core antibody (HbcAb), Hepatitis C virus antibody (anti- HCV) or Human Immunodeficiency antibody (anti-HIV) * Presence or risk of venous thromboembolism (VTE) arterial thromboembolism (ATE) * Diabetes mellitus (Type 1 or Type 2) with vascular manifestations * Signs or symptoms of neurological disease other than multiple sclerosis (MS) that could explain the symptoms of the participant * Presence of gastrointestinal (GI) disease or history of gastrointestinal -tract surgery * Exposure to another investigational drug within the last 2 months or within last 6 month if agent is known to be immunosuppressive * Other protocol defined exclusion criteria could apply

Locations (7)

St. Josef und St. Elisabeth Hospital gGmbH

Bochum, Germany

Nuvisan GmbH

Neu-Ulm, Germany

M.A. - LEK A.M.Maciejowscy SC.

Katowice, Poland

BioResearch Group Sp. z o. o

Nadarzyn, Poland

Outcomes

Primary Outcomes

Area Under the Plasma Concentration-Time Curve From Zero to Tau at Steady State (AUCt,ss) of Ethinyl Estradiol and Levonorgestrel

Area under the plasma concentration-time curve from zero to tau at steady state (AUCt,ss) of ethinyl estradiol and levonorgestrel were reported. Calculated using descriptive statistics.