Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-24 @ 3:41 PM
NCT ID:
NCT00396292
Eligibility Criteria:
Inclusion Criteria:
* Female Subjects able to give consent
* Post partum patients
* Baseline Hbg\< /= 10
* Agree to practice birth control
* Demonstrate willingness to comply with protocol restrictions
Exclusion Criteria:
* Known hypersensitivity reaction to oral or IV iron (VIT-45)
* Documented history of discontinuing oral iron
* Significant bleeding
* History of anemia other that iron deficiency anemia
* Severe Psychiatric disorders
* Active severe infection
* Known Hepatitis B antigen or Hep C viral antibody or active hepatitis
* Known HIV antibody
* Received investigational product within 30 days
* Alcohol abuse
* Hemochromatosis or other iron storage disorder
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00396292
Study Brief:
Protocol Section:
NCT00396292