Trial Outcomes & Findings for Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding (NCT NCT00395993)
NCT ID: NCT00395993
Last Updated: 2018-02-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
456 participants
Primary outcome timeframe
Any time between baseline and the end of study or time to intervention
Results posted on
2018-02-20
Participant Flow
Hospitals and medical clinics
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
246
|
231
|
|
Overall Study
COMPLETED
|
211
|
212
|
|
Overall Study
NOT COMPLETED
|
35
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding
Baseline characteristics by cohort
| Measure |
Ferric Carboxymaltose (FCM)
n=230 Participants
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
n=226 Participants
325 mg tablets TID on Days 0 through Day 42
|
Total
n=456 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
228 Participants
n=99 Participants
|
226 Participants
n=107 Participants
|
454 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
38.7 years
STANDARD_DEVIATION 7.49 • n=99 Participants
|
39.5 years
STANDARD_DEVIATION 7.63 • n=107 Participants
|
39.1 years
STANDARD_DEVIATION 7.54 • n=206 Participants
|
|
Sex: Female, Male
Female
|
230 Participants
n=99 Participants
|
226 Participants
n=107 Participants
|
456 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
230 participants
n=99 Participants
|
226 participants
n=107 Participants
|
456 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Any time between baseline and the end of study or time to interventionPopulation: 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.
Outcome measures
| Measure |
Ferric Carboxymaltose (FCM)
n=228 Participants
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
n=225 Participants
325 mg tablets TID on Days 0 through Day 42
|
|---|---|---|
|
Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL
|
187 participants
|
139 participants
|
Adverse Events
Ferric Carboxymaltose (FCM)
Serious events: 3 serious events
Other events: 120 other events
Deaths: 0 deaths
Oral Iron Tablets
Serious events: 3 serious events
Other events: 133 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ferric Carboxymaltose (FCM)
n=230 participants at risk
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
n=226 participants at risk
325 mg tablets TID on Days 0 through Day 42
|
|---|---|---|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
0.43%
1/230 • 11 months
|
0.44%
1/226 • 11 months
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/230 • 11 months
|
0.44%
1/226 • 11 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/230 • 11 months
|
0.44%
1/226 • 11 months
|
|
General disorders
Chest pain
|
0.43%
1/230 • 11 months
|
0.00%
0/226 • 11 months
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.43%
1/230 • 11 months
|
0.00%
0/226 • 11 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/230 • 11 months
|
0.44%
1/226 • 11 months
|
Other adverse events
| Measure |
Ferric Carboxymaltose (FCM)
n=230 participants at risk
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
n=226 participants at risk
325 mg tablets TID on Days 0 through Day 42
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
3.5%
8/230 • 11 months
|
15.5%
35/226 • 11 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.5%
8/230 • 11 months
|
5.8%
13/226 • 11 months
|
|
Gastrointestinal disorders
Abdominal pain
|
5.2%
12/230 • 11 months
|
2.7%
6/226 • 11 months
|
|
Gastrointestinal disorders
Nausea
|
5.2%
12/230 • 11 months
|
14.6%
33/226 • 11 months
|
|
General disorders
Fatigue
|
5.7%
13/230 • 11 months
|
2.2%
5/226 • 11 months
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
7/230 • 11 months
|
6.2%
14/226 • 11 months
|
|
Renal and urinary disorders
Blood phosphorus decreased
|
11.3%
26/230 • 11 months
|
0.00%
0/226 • 11 months
|
|
Nervous system disorders
Headache
|
14.8%
34/230 • 11 months
|
11.9%
27/226 • 11 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60