Anemia
Conditions
Keywords
anemia, heavy uterine bleeding, menorrhagia, Anemia secondary to heavy uterine bleeding
Brief 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
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.
Interventions
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
Sponsors
American Regent, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL | Any time between baseline and the end of study or time to intervention |
Countries
United States
Participant flow
Recruitment details
Hospitals and medical clinics
Participants by arm
| Arm | Count |
|---|---|
| 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 | 230 |
| Oral Iron Tablets 325 mg tablets TID on Days 0 through Day 42 | 226 |
| Total | 456 |
Baseline characteristics
| Characteristic | Oral Iron Tablets | Ferric Carboxymaltose (FCM) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 226 Participants | 228 Participants | 454 Participants |
| Age, Continuous | 39.5 years STANDARD_DEVIATION 7.63 | 38.7 years STANDARD_DEVIATION 7.49 | 39.1 years STANDARD_DEVIATION 7.54 |
| Region of Enrollment United States | 226 participants | 230 participants | 456 participants |
| Sex: Female, Male Female | 226 Participants | 230 Participants | 456 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 120 / 230 | 133 / 226 |
| serious Total, serious adverse events | 3 / 230 | 3 / 226 |
Outcome results
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Ferric Carboxymaltose (FCM) | Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL | 187 participants |
| Oral Iron Tablets | Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL | 139 participants |