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Effects of Cladribine Tablets on the PK of Microgynon®

CompletedPhase 1

Sponsor: Merck KGaA, Darmstadt, Germany

Conditions: Relapsing Multiple Sclerosis (RMS)

Interventions: Cladribine, Placebo, Microgynon®

Countries: Germany, Poland

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).

Eligibility overview

Sex: FEMALE

Age: 18 Years to 45 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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)

Bochum, Germany
Neu-Ulm, Germany
Katowice, Poland
Nadarzyn, Poland
Nałęczów, Poland
Otwock, Poland
Warsaw, Poland