ferric carboxymaltose treatment to improve fatigue symptoms in iron-deficient non-anaemic women of child bearing age

Conditions: Iron Deficiency

Summary: research study of ferric carboxymaltose to treat fatigue/exhaustion symptoms, believed to be due to iron deficiency.


Eligibility criteria:
inclusion criteria: * signed informed consent prior to study specific procedures. * premenopausal, regularly menstruating women. * age ≥18 years. * body weight between 50 and 90 kg. * haemoglobin ≥115 g/l. * iron deficiency at screening defined as follows: * s-ferritin level \<50 ng/ml, and, tfs \<20%, or, * s-ferritin level \<15 ng/ml. * serum c-reactive protein: * \<5 mg/l if not on oral contraception, or, * \<20 mg/l if use of oral contraception. * minimum total score of 5 on the piper fatigue scale (pfs) (mean of items 2 to 23). * negative pregnancy test (serum human chorionic gonadotropin (hcg) at screening. * normal levels of vitamin b12 and folic acid at screening. * adequate contraception during the study period and for 1 month following study completion. * availability and willingness to complete all study visits and procedures per protocol. exclusion criteria: * haemoglobin level \<115 g/l. * haemoglobinopathy. * haemochromatose. * major depressive disorder based on patient health questionnaire (phq-9) (5 items with scores ≥2; one of which corresponds to question number 1 or 2). * any active or unstable concurrent medical condition (e.g., cancer, renal dysfunction, liver dysfunction (aspartate aminotransferase (ast); alanine aminotransferase (alt) \>3-fold upper limit), angina (class iv). * known human immunodeficiency virus/acquired immunodeficiency syndrome, hepatitis b virus or hepatitis c virus infection. * chronic inflammatory disease (e.g., rheumatoid arthritis; inflammatory bowel disease). * documented history of clinically significant level of sleep apnoea defined as 5 or more episodes per hour of any type of apnoea. * intake of concurrent medications that could interfere with physical or mental performance (e.g., antidepressive, antihistamines, narcotic or any chemotherapeutic agents known to cause drowsiness). * important recent weight loss (\>10% within the past month). * body weight \ 90 kg. * thyroid dysfunction, thyroid stimulating hormone \>4 μu/ml. * intake of iron preparations 4 weeks prior to screening. * use of gestagens e.g., implanon, mirena, depo-provera for menstruation repression (see section 7.7, prohibited therapy or concomitant treatment, page 35). * known hypersensitivity to fcm or to any other iron preparation. * pregnancy (positive hcg test at screening) or breast feeding. * participation in any other interventional trial within 4 weeks prior to screening. * inability to fully comprehend and/or perform study procedures or provide written consent in the investigator's opinion. * subject is not using adequate contraceptive precautions during the study and for up to 1 month after the last dose of the study medication. a highly effective method of birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner. * subject previously has entered this study. * subject will not be available for follow-up assessments.