A Multicentre Randomised Placebo-controlled Study to Assess the Efficacy and Safety of a Single Administration of Ferric Carboxymaltose (1,000 mg iron) in Improving Fatigue Symptoms in Iron-deficient Non-anaemic (IDNA) Women of Child Bearing Age

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 288

Inclusion Criteria

1. Signed informed consent prior to study specific procedures.

2. Premenopausal, regularly menstruating women.

3. Age =18 years.

4. Body weight between 50 and 90 kg.

5. Haemoglobin =115 g/L.

6. Iron deficiency at screening defined as follows:
- S-ferritin level <50 ng/mL, AND, TfS <20%, OR,
- S-ferritin level <15 ng/mL.

7. Serum C-reactive protein:
- <5 mg/L if not on oral contraception, OR,
- <20 mg/L if use of oral contraception.

8. Minimum total score of 5 on the Piper Fatigue Scale (PFS) (mean of items
2 to 23).

9. Negative pregnancy test (serum human chorionic gonadotropin (hCG) at
screening.

10. Normal levels of vitamin B12 and folic acid at screening.

11. Adequate contraception during the study period and for 1 month following
study completion.

12. Availability and willingness to complete all study visits and procedures per
protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Haemoglobin level <115 g/L.

2. Haemoglobinopathy.

3. Haemochromatose.

4. 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).

5. 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).

6. Known human immunodeficiency virus/acquired immunodeficiency
syndrome, hepatitis B virus or hepatitis C virus infection.

7. Chronic inflammatory disease (e.g., rheumatoid arthritis; inflammatory
bowel disease).

8. Documented history of clinically significant level of sleep apnoea defined
as 5 or more episodes per hour of any type of apnoea.

9. 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).

10. Important recent weight loss (>10% within the past month).

11. Body weight <50 kg or >90 kg.

12. Thyroid dysfunction, thyroid stimulating hormone >4 µU/mL.

13. Intake of iron preparations 4 weeks prior to screening.

14. Use of gestagens e.g., Implanon® Mirena®, Depo-
Provera® for menstruation repression (see Section 7.7, Prohibited Therapy
or Concomitant Treatment, page 35).

15. Known hypersensitivity to FCM or to any other iron preparation.

16. Pregnancy (positive hCG test at screening) or breast feeding.

17. Participation in any other interventional trial within 4 weeks prior to
screening.

18. Inability to fully comprehend and/or perform study procedures or provide
written consent in the Investigator’s opinion.

19. 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.

20. Subject previously has entered this study.

21. Subject will not be available for follow-up assessments.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials