Clinical Study Evaluating the Efficacy of Iron Proteinsuccinylate Oral Solution（FERPLEX） in Women With Gynecologic Iron Deficiency Anemia (CSETEOIPOS)

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 obstetrics and gynecology in China.All patients who met the inclusion criteria and agreed to participate in the study received routine blood tests, serum ferritin, serum iron and total iron binding ability tests and clinical follow-up. All patients were given 15ml oral protein iron succinate solution (Fiapril) in the morning and evening each day.Blood routine examinations (Hb, reticulocytes, RBC, HCT), serum ferritin, serum iron and total iron binding ability were detected at the 1st, 4th, 8th and 12th weeks of the study to observe the change trend of their own indicators.Symptom self-assessment tables were collected to assess the improvement rate of clinical symptoms including dizziness, fatigue, chest tightness and palpitations, and to record the incidence of adverse reactions (mainly gastrointestinal reactions).

Study Overview

• Status: Not yet recruiting
• Conditions: Patients With Iron Deficiency Anemia in Gynecology

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 obstetrics and gynecology in 4 centers nationwide.

All patients who met the inclusion criteria and agreed to participate in the study received routine blood tests, serum ferritin, serum iron and total iron binding ability tests and clinical follow-up. All patients were given 15ml Iron Proteinsuccinylate Oral Solution in the morning and evening each day.

Evaluation of therapeutic efficacy: Blood routine examinations (Hb, reticulocytic cell, RBC, HCT), serum ferritin, serum iron and total iron binding force were collected at week 1, 4, 8 and 12 of the study. Patients self-rated clinical symptoms such as dizziness, fatigue, chest tightness and palpitations.To evaluate laboratory measures of improvement and response rate (symptom relief) in patients with uterine fibroids and adenomyosis induced iron deficiency anemia presented to the department of obstetrics and gynecology, and the incidence of complications during the study period。 Patients with iron deficiency anemia caused by uterine fibroids and adenomyosis in the department of obstetrics and gynecology included in this study group were followed up for 12 weeks.The results of patients' self-assessed symptoms, including blood routine (Hb, reticulocyte, RBC, HCT), serum ferritin, serum iron, total iron binding ability and other indicators, as well as the occurrence of complications at baseline level and during short-term follow-up of 12 weeks, will be collected to determine the clinical outcomes of patients through hospital follow-up.

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

• Study Contact: Name: ningzhou xue, master; Phone Number: 86 13156212575; Email: ningzhou.xue@leespharm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with iron deficiency anemia caused by uterine leiomyoma and adenomyosis in gynecology and obstetrics

Description

Inclusion Criteria:

1. female, aged from 18 to 65 years old;
2. 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.
3. 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.
4. willing to sign informed consent.

Exclusion Criteria:

1. 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.;
2. patients who use intravenous, intramuscular injection and other oral drugs to supplement iron at the same time;
3. patients with malignant tumors.
4. severe cardiopulmonary disease (NYHA cardiac function IV or respiratory failure);
5. obvious renal function impairment (serum creatinine ≥ 2mg/dL or glomerular filtration rate GFR < 40mL/min);
6. liver insufficiency (liver function: total bilirubin > ULN, aspartate aminotransferase (AST), alanine transaminase (ALT) and alkaline phosphatase (ALP) ≥ 2.0 × ULN).
7. patients with immune function, sepsis and serious diseases of endocrine system;
8. 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HB	The levels of hemoglobin in 1 week of treatment.	The first week of treatment
SF	The levels of serum ferritin in 1 week of treatment.	The first week of treatment
HB	The levels of hemoglobin in 4 week of treatment.	The fourth week of treatment
SF	The levels of serum ferritin in 4 week of treatment.	The fourth week of treatment
HB	The levels of hemoglobin in 8 week of treatment.	Eight weeks after treatment
SF	The levels of serum ferritin in 8 week of treatment.	Eight weeks after treatment
HB	The levels of hemoglobin in 12 weeks of treatment.	Twelve weeks after treatment
SF	The levels of serum ferritin in 12 weeks of treatment.	Twelve weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RBC	The levels of red blood cell in 1week of treatment.	1 weeks after treatment.
HCT	The levels of hematocrit in 1week of treatment.	1 weeks after treatment.
SI	The levels of free iron in 1week of treatment.	1 weeks after treatment.
RBC	The levels of red blood cell in 4weeks of treatment.	4 weeks after treatment.
HCT	The levels of hematocrit in 4weeks of treatment.	4 weeks after treatment.
SI	The levels of free iron in 4 weeks of treatment.	4 weeks after treatment.
RBC	The levels of red blood cell in 8 weeks of treatment.	8 weeks after treatment.
HCT	The levels of hematocrit in 8 weeks of treatment.	8 weeks after treatment.
SI	The levels of free iron in 8 weeks of treatment.	8 weeks after treatment.
RBC	The levels of red blood cell in 12 weeks of treatment.	12 weeks after treatment.
HCT	The levels of hematocrit in 12 weeks of treatment.	12 weeks after treatment.
SI	The levels of free iron in 12 weeks of treatment.	12 weeks after treatment.

Collaborators and Investigators

• Sponsor: Lee's Pharmaceutical Limited

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2022
• Primary Completion (Anticipated): March 15, 2023
• Study Completion (Anticipated): March 15, 2023

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: December 30, 2021
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 13, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Iron deficiency anemia,Gynecology
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Nutrition Disorders; Anemia, Hypochromic; Iron Metabolism Disorders; Malnutrition; Anemia, Iron-Deficiency; Anemia; Deficiency Diseases
• Other Study ID Numbers: FPL-LEES-2021-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No