Clinical trial NCT05192291: Clinical Study Evaluating the Efficacy of Iron Proteinsuccinylate Oral Solution（FERPLEX） in Women With Gynecologic Iron Deficiency Anemia
Official title: Clinical Study Evaluating the Efficacy of Iron Proteinsuccinylate Oral Solution（FERPLEX） in Women With Gynecologic Iron Deficiency Anemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients With Iron Deficiency Anemia in Gynecology
Keywords: Iron deficiency anemia,Gynecology
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2022-01-14
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with iron deficiency anemia caused by uterine leiomyoma and adenomyosis in gynecology and obstetrics

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 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HB
timeFrame: The first week of treatment
measure: SF
timeFrame: The first week of treatment
measure: HB
timeFrame: The fourth week of treatment
measure: SF
timeFrame: The fourth week of treatment
measure: HB
timeFrame: Eight weeks after treatment
measure: SF
timeFrame: Eight weeks after treatment
measure: HB
timeFrame: Twelve weeks after treatment
measure: SF
timeFrame: Twelve weeks after treatment
Secondary outcomes:
measure: RBC
timeFrame: 1 weeks after treatment.
measure: HCT
timeFrame: 1 weeks after treatment.
measure: SI
timeFrame: 1 weeks after treatment.
measure: RBC
timeFrame: 4 weeks after treatment.
measure: HCT
timeFrame: 4 weeks after treatment.
measure: SI
timeFrame: 4 weeks after treatment.
measure: RBC
timeFrame: 8 weeks after treatment.
measure: HCT
timeFrame: 8 weeks after treatment.
measure: SI
timeFrame: 8 weeks after treatment.
measure: RBC
timeFrame: 12 weeks after treatment.
measure: HCT
timeFrame: 12 weeks after treatment.
measure: SI
timeFrame: 12 weeks after treatment.
Other outcomes:
Locations:
Study officials:
References: