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CompletedNCT00395993Updated Feb 20, 2018Results posted

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

A Phase 3 interventional study of Ferric Carboxymaltose (FCM) and Ferrous Sulfate tablets in Anemia, sponsored by American Regent, Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-20.

Sponsored by American Regent, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
456
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

This study compares of the safety and efficacy of intravenous iron vs oral iron in the treatment of anemia secondary to heavy uterine bleeding

Read the detailed description

This is an open-label, randomized, Phase III, active-control, study of the efficacy and safety of IV iron vs oral iron in patients with anemia secondary to heavy uterine bleeding.

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Conditions studied

  • Anemia

Keywords

  • anemia
  • heavy uterine bleeding
  • menorrhagia
  • Anemia secondary to heavy uterine bleeding
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In context

Uterine Hemorrhage

156 studies on the registry are indexed under Uterine Hemorrhage; 19 are open to participants now.

This study's enrollment of 456 is above the median of 96 across 111 interventional studies indexed under Uterine Hemorrhage.

Browse Uterine Hemorrhage studies →

Lead sponsor

American Regent, Inc. is the lead sponsor of 53 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Female subjects >/= 18 years of age
  • History of Heavy uterine bleeding
  • Hgb \</= 11
  • Practicing acceptable birth control
  • Demonstrate ability to understand and comply with protocol

Exclusion criteria

Exclusion Criteria:

  • Known Hypersensitivity to oral or IV iron
  • Anemia other than iron deficiency anemia
  • Iron storage disorders
  • Initiation of treatment that may effect degree of heavy uterine bleeding
  • Anticipated need for surgery
  • Severe psychiatric disorder
  • Active infection
  • Positive Pregnancy test
  • Known Hep B or C or Active Hepatitis
  • Received investigational Drug within 30 days
  • Alcohol or drug abuse
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
456 participants (actual)

Study arms

  • Experimental
    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

    Drug: Ferric Carboxymaltose (FCM)

  • Active comparator
    Ferrous Sulfate tablets

    325 mg tablets TID on Days 0 through Day 42

    Drug: Ferrous Sulfate tablets

Interventions

  • DrugFerric 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

  • DrugFerrous Sulfate tablets

    325 mg tablets TID on Days 0 through Day 42

    Also known as: Oral Iron Tablets

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What researchers measure

Primary outcomes

  1. 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

07

Results

Posted Nov 18, 2013

Participant flow

Hospitals and medical clinics

Participant flow — Overall Study
MilestoneFerric Carboxymaltose (FCM)Oral Iron Tablets
Started246231
Completed211212
Not completed3519

Outcome measures

PrimaryNumber 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
Reported as:
Number · participants
Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL
participantsFerric Carboxymaltose (FCM)Oral Iron Tablets
Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL187139

Adverse events

Collected over 11 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ferric Carboxymaltose (FCM)—3/230 (1.3%)120/230 (52.2%)
Oral Iron Tablets—3/226 (1.3%)133/226 (58.8%)
Most frequent serious events
Most frequent serious events
EventFerric Carboxymaltose (FCM)Oral Iron Tablets
Uterine hemorrhageReproductive system and breast disorders1/2301/226
Transient ischemic attackNervous system disorders0/2301/226
Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/2301/226
Abdominal painGastrointestinal disorders0/2301/226
Chest painGeneral disorders1/2300/226
Pelvic inflammatory diseaseInfections and infestations1/2300/226
Most frequent other events
Most frequent other events
EventFerric Carboxymaltose (FCM)Oral Iron Tablets
ConstipationGastrointestinal disorders8/23035/226
HeadacheNervous system disorders34/23027/226
NauseaGastrointestinal disorders12/23033/226
Blood phosphorus decreasedRenal and urinary disorders26/2300/226
NasopharyngitisInfections and infestations7/23014/226
DiarrheaGastrointestinal disorders8/23013/226
FatigueGeneral disorders13/2305/226
Abdominal painGastrointestinal disorders12/2306/226

Baseline characteristics

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
Age, Categorical(Participants)Ferric Carboxymaltose (FCM)Oral Iron TabletsTotal
<=18 years202
Between 18 and 65 years228226454
>=65 years000
Age, Continuous
Age, Continuous(years)Ferric Carboxymaltose (FCM)Oral Iron TabletsTotal
Mean38.7 ± 7.4939.5 ± 7.6339.1 ± 7.54
Sex: Female, Male
Sex: Female, Male(Participants)Ferric Carboxymaltose (FCM)Oral Iron TabletsTotal
Female230226456
Male000
Region of Enrollment
Region of Enrollment(participants)Ferric Carboxymaltose (FCM)Oral Iron TabletsTotal
United States230226456
08

Study locations

1 site
  • Luitpold Pharmaceuticals, Inc.
    Norristown, Pennsylvania 19403, United States
09

References and documents

Publications

  • 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.
  • Morrison J, Patel ST, Watson W, Zaidi QR, Mangione A, Goss TF. Assessment of the prevalence and impact of anemia on women hospitalized for gynecologic conditions associated with heavy uterine bleeding. J Reprod Med. 2008 May;53(5):323-30. PubMed 18567277 ↗
  • James AH, Patel ST, Watson W, Zaidi QR, Mangione A, Goss TF. An assessment of medical resource utilization and hospitalization cost associated with a diagnosis of anemia in women with obstetrical bleeding in the United States. J Womens Health (Larchmt). 2008 Oct;17(8):1279-84. doi: 10.1089/jwh.2007.0605. PubMed 18752459 ↗
  • Van Wyck DB, Mangione A, Morrison J, Hadley PE, Jehle JA, Goodnough LT. Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. Transfusion. 2009 Dec;49(12):2719-28. doi: 10.1111/j.1537-2995.2009.02327.x. Epub 2009 Jul 22. PubMed 19682342 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00395993
Lead sponsor
American Regent, Inc.
Responsible party
Sponsor
First posted
Nov 6, 2006
Start date
May 2005
Primary completion
Apr 2006
Completion
Jun 2006
Results posted
Nov 18, 2013
Last update
Feb 20, 2018
View the source record on ClinicalTrials.gov ↗

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