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

A Multicentre Randomised Placebo-controlled Study to Assess the Efficacy and Safety of a Single Administration of Ferric Carboxymaltose in Improving Fatigue Symptoms in Iron-deficient Non-anaemic Women of Child Bearing Age

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

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.