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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Hospitals and medical clinics

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ferric Carboxymaltose (FCM) 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
Oral Iron Tablets 325 mg tablets TID on Days 0 through Day 42

Participant Flow:   Overall Study
    Ferric Carboxymaltose (FCM)   Oral Iron Tablets
STARTED   246   231 
COMPLETED   211   212 
NOT COMPLETED   35   19 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Ferric Carboxymaltose (FCM) 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
Oral Iron Tablets 325 mg tablets TID on Days 0 through Day 42
Total Total of all reporting groups

Baseline Measures
   Ferric Carboxymaltose (FCM)   Oral Iron Tablets   Total 
Overall Participants Analyzed 
[Units: Participants]
 230   226   456 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 38.7  (7.49)   39.5  (7.63)   39.1  (7.54) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      230 100.0%      226 100.0%      456 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   230   226   456 


  Outcome Measures

1.  Primary:   Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL   [ Time Frame: Any time between baseline and the end of study or time to intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: mfalone@luitpold.com


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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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