Status:
UNKNOWN
Clinical Study Evaluating the Efficacy of Iron Proteinsuccinylate Oral Solution（FERPLEX） in Women With Gynecologic Iron Deficiency Anemia
Lead Sponsor:
Lee's Pharmaceutical Limited
Conditions:
Patients With Iron Deficiency Anemia in Gynecology
Eligibility:
FEMALE
18-65 years
Brief Summary
This study is a prospective, open and non-interventionalclinical study. It is planned to enroll 240 patients with iron deficiency anemia caused by uterine fibroids and adenomyosis in 4 centers of obst...
Detailed Description
This project is a prospective, open, non-interventionalclinical study. It is planned to enroll 240 patients with iron deficiency anemia caused by uterine fibroids and adenomyosis in the department of ...
Eligibility Criteria
Inclusion
- female, aged from 18 to 65 years old;
- according to the patient's blood routine, serum ferritin and other indexes as well as clinical manifestations and signs, it was clearly diagnosed as iron deficiency anemia.
- all patients were diagnosed with uterine leiomyoma and / or adenomyosis by B-ultrasound, and gonadotropin-releasing hormone agonist (GnRH-a), levonorgestrel intrauterine delivery system (LNG-IUS, Manyuele), compound oral contraceptive (COC) and mifepristone could be used to interfere with menstruation.
- willing to sign informed consent.
Exclusion
- patients with other types of anemia: such as hereditary anemia, immune anemia, large cell anemia, microvascular anemia, renal anemia, hypofunction of endocrine glands (such as pituitary, thyroid), infectious anemia, etc.;
- patients who use intravenous, intramuscular injection and other oral drugs to supplement iron at the same time;
- patients with malignant tumors.
- severe cardiopulmonary disease (NYHA cardiac function IV or respiratory failure);
- obvious renal function impairment (serum creatinine ≥ 2mg/dL or glomerular filtration rate GFR \< 40mL/min);
- liver insufficiency (liver function: total bilirubin \> ULN, aspartate aminotransferase (AST), alanine transaminase (ALT) and alkaline phosphatase (ALP) ≥ 2.0 × ULN).
- patients with immune function, sepsis and serious diseases of endocrine system;
- drug addicts or alcoholics; 9) people who have participated in other drug trials within 3 months; 10) researchers think it is not suitable for participants.
Key Trial Info
Start Date :
March 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 15 2023
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05192291
Start Date
March 15 2022
End Date
March 15 2023
Last Update
February 15 2022
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