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NCT Number: NCT00395993

Comparison of the Safety and Efficacy of Intravenous Iron Versus 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

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Key information

Conditions

Anemia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Menorrhagia Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Luitpold Pharmaceuticals, Inc.

Norristown, Pennsylvania, 19403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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 tablets

Drug

325 mg tablets TID on Days 0 through Day 42

Other names: Oral Iron Tablets

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

Sponsors and collaborators

Lead sponsor

American Regent, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Nov 6, 2006
Registry last updated
Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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