Ferric Carboxymaltose Treatment to Improve Fatigue Symptoms in Iron-deficient Non-anaemic Women of Child Bearing Age

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 \<50 kg or \>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.