Effects of Cladribine Tablets on the PK of Microgynon®

  • STATUS
    Recruiting
  • days left to enroll
    14
  • participants needed
    23
  • sponsor
    Merck KGaA, Darmstadt, Germany
Updated on 16 January 2022

Summary

The purpose of this study is 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).

Details
Condition Relapsing Multiple Sclerosis (RMS)
Treatment Placebo, cladribine, Microgynon®
Clinical Study IdentifierNCT03745144
SponsorMerck KGaA, Darmstadt, Germany
Last Modified on16 January 2022

Eligibility

Yes No Not Sure

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
Have 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
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