Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck KGaA, Darmstadt, Germany
Age
18–45
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
