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Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding

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ClinicalTrials.gov Identifier: NCT00395993
Recruitment Status : Completed
First Posted : November 6, 2006
Results First Posted : November 18, 2013
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Luitpold Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anemia
Interventions Drug: Ferric Carboxymaltose (FCM)
Drug: Ferrous Sulfate tablets
Enrollment 456
Recruitment Details Hospitals and medical clinics
Pre-assignment Details  
Arm/Group Title Ferric Carboxymaltose (FCM) Oral Iron Tablets
Hide Arm/Group Description Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered 325 mg tablets TID on Days 0 through Day 42
Period Title: Overall Study
Started 246 231
Completed 211 212
Not Completed 35 19
Arm/Group Title Ferric Carboxymaltose (FCM) Oral Iron Tablets Total
Hide Arm/Group Description Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered 325 mg tablets TID on Days 0 through Day 42 Total of all reporting groups
Overall Number of Baseline Participants 230 226 456
Hide Baseline Analysis Population Description
16 of the 246 subjects randomized to FCM were discontinued prior to dosing and 5 of the 231 subjects randomized to oral iron were discontinued prior to dosing.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 230 participants 226 participants 456 participants
<=18 years
2
   0.9%
0
   0.0%
2
   0.4%
Between 18 and 65 years
228
  99.1%
226
 100.0%
454
  99.6%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 230 participants 226 participants 456 participants
38.7  (7.49) 39.5  (7.63) 39.1  (7.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 230 participants 226 participants 456 participants
Female
230
 100.0%
226
 100.0%
456
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 230 participants 226 participants 456 participants
230 226 456
1.Primary Outcome
Title Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL
Hide Description [Not Specified]
Time Frame Any time between baseline and the end of study or time to intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat Population defined as subjects from the Safety Population who received at least 1 dose of study medication, had average baseline hemoglobin, TSAT, and ferritin levels, had heavy uterine bleeding, and had at least 1 post-baseline hemoglobin assessment.
Arm/Group Title Ferric Carboxymaltose (FCM) Oral Iron Tablets
Hide Arm/Group Description:
Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
325 mg tablets TID on Days 0 through Day 42
Overall Number of Participants Analyzed 228 225
Measure Type: Number
Unit of Measure: participants
187 139
Time Frame 11 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ferric Carboxymaltose (FCM) Oral Iron Tablets
Hide Arm/Group Description Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered 325 mg tablets TID on Days 0 through Day 42
All-Cause Mortality
Ferric Carboxymaltose (FCM) Oral Iron Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ferric Carboxymaltose (FCM) Oral Iron Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   3/230 (1.30%)   3/226 (1.33%) 
Gastrointestinal disorders     
Abdominal pain  0/230 (0.00%)  1/226 (0.44%) 
General disorders     
Chest pain  1/230 (0.43%)  0/226 (0.00%) 
Infections and infestations     
Pelvic inflammatory disease  1/230 (0.43%)  0/226 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine leiomyoma  0/230 (0.00%)  1/226 (0.44%) 
Nervous system disorders     
Transient ischemic attack  0/230 (0.00%)  1/226 (0.44%) 
Reproductive system and breast disorders     
Uterine hemorrhage  1/230 (0.43%)  1/226 (0.44%) 
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ferric Carboxymaltose (FCM) Oral Iron Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   120/230 (52.17%)   133/226 (58.85%) 
Gastrointestinal disorders     
Constipation  8/230 (3.48%)  35/226 (15.49%) 
Diarrhea  8/230 (3.48%)  13/226 (5.75%) 
Abdominal pain  12/230 (5.22%)  6/226 (2.65%) 
Nausea  12/230 (5.22%)  33/226 (14.60%) 
General disorders     
Fatigue  13/230 (5.65%)  5/226 (2.21%) 
Infections and infestations     
Nasopharyngitis  7/230 (3.04%)  14/226 (6.19%) 
Nervous system disorders     
Headache  34/230 (14.78%)  27/226 (11.95%) 
Renal and urinary disorders     
Blood phosphorus decreased  26/230 (11.30%)  0/226 (0.00%) 
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Mark A. Falone, MD
Organization: Luitpold Pharmaceuticals, Inc.
Phone: 610-650-4200
Publications of Results:
Gordon S, Hadley PE, Van Wyck DB, Mangione A. Ferric Carboxymaltose, a New IV Iron Agent for Iron Deficiency Anemia in Heavy Uterine Bleeding. Society for the Advancement of Blood Management 6th Annual Meeting 2007.
Gordon S, Hadley PE, Van Wyck DB, Mangione A. Iron Carboxymaltose, a New Intravenous Iron Agent for Iron Deficiency Anemia in Heavy Uterine Bleeding. American College of Obstetricians & Gynecologists: 108S 2007.
James A, Patel S, Dinh Q. Impact of Anemia on Medical Resource Utilization and Hospitalization Cost in Women with Obstretrical Bleeding. The Journal of Reproductive Medicine 2008.
Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00395993     History of Changes
Other Study ID Numbers: 1VIT04002/003
First Submitted: November 2, 2006
First Posted: November 6, 2006
Results First Submitted: September 16, 2013
Results First Posted: November 18, 2013
Last Update Posted: February 20, 2018