AnemiaPhase 3NCT00395993

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 study testing Ferric Carboxymaltose (FCM) and Ferrous Sulfate tablets in people with Anemia, run by American Regent, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Anemia
What is being tested?: Ferric Carboxymaltose (FCM) and Ferrous Sulfate tablets
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 456 participants
Where: 1 siteUnited States
Study dates: May 2005to Jun 2006
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

Active infection
Positive Pregnancy test
Known Hep B or C or Active Hepatitis
Received investigational Drug within 30 days
Alcohol or drug abuse

Trial locations and contacts

1 site in 1 country.

United States1 site

Luitpold Pharmaceuticals, Inc.
Norristown, Pennsylvania, 19403

Other trials in United States

About this study

Official title: Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding

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.

Conditions: Anemia
Being tested: Ferric Carboxymaltose (FCM), Ferrous Sulfate tablets
Keywords: anemia, heavy uterine bleeding, menorrhagia, Anemia secondary to heavy uterine bleeding
Medical subject headings: Anemia, Menorrhagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ferric Carboxymaltose (FCM)Drug
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
Ferrous Sulfate tabletsDrug
Also called Oral Iron Tablets
325 mg tablets TID on Days 0 through Day 42

Study groups in NCT00395993
Study group	Role	What they receive
Ferric Carboxymaltose (FCM)	Experimental	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 Receives: Drug: Ferric Carboxymaltose (FCM)
Ferrous Sulfate tablets	Active comparator	325 mg tablets TID on Days 0 through Day 42 Receives: Drug: Ferrous Sulfate tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2005Jun 2006

First posted6 Nov 2006 (estimated)
Study startMay 2005
Primary completionApr 2006
Study completionJun 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for AnemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 456 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00395993
Sponsor's protocol ID: 1VIT04002/003
Status last verified: Jan 2018
First submitted: 2 Nov 2006
Last updated: 20 Feb 2018
Results posted: Yes, on ClinicalTrials.gov

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding
ClinicalTrials.gov ID: NCT00395993
Acronym / sponsor ID: 1VIT04002/003
Conditions: Anemia
Keywords: anemia, heavy uterine bleeding, menorrhagia, Anemia secondary to heavy uterine bleeding
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 456 participants (actual)
Lead sponsor: American Regent, Inc.Industry (pharma, biotech, devices)
Study start: May 2005
Primary completion: Apr 2006 (actual)
Study completion: Jun 2006 (actual)
First posted: 6 Nov 2006 (estimated)
Results: Posted 18 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ferric Carboxymaltose (FCM)	Experimental	Drug: 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
Ferrous Sulfate tablets	Active comparator	Drug: Ferrous Sulfate tablets325 mg tablets TID on Days 0 through Day 42

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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)
Ferrous Sulfate tabletsAlso: Oral Iron Tablets325 mg tablets TID on Days 0 through Day 42	Drug	Ferrous Sulfate tablets

Primary outcome

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

Results and safety

Results posted to the registry on 18 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ferric Carboxymaltose (FCM)	246	211
Oral Iron Tablets	231	212

Primary outcome: 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. Number. Unit: participants

Measure	Ferric Carboxymaltose (FCM) n = 228	Oral Iron Tablets n = 225
Value	187	139

Population analysed: 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.

Adverse events

Time frame: 11 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ferric Carboxymaltose (FCM)	3 of 230 (1.3%)	120 of 230 (52.2%)	Not reported
Oral Iron Tablets	3 of 226 (1.3%)	133 of 226 (58.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationGordon 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.
Results publicationGordon 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.
Results publication: PubMed 18567277Morrison 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.
Results publication: PubMed 18752459James 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.
Derived from this study: PubMed 19682342Van 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ferric Carboxymaltose (FCM) and Ferrous Sulfate tablets in people with Anemia, run by American Regent, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00395993, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2018.