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

NCT05192291 | Unknown

• 1 other identifier: FPL-LEES-2021-12
• Study Type: observational
• Target: 240
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Patients With Iron Deficiency Anemia in Gynecology

Keywords

Iron deficiency anemia,Gynecology

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (12)

• RBC

  1 weeks after treatment.

• HCT

  1 weeks after treatment.

• SI

  1 weeks after treatment.

• RBC

  4 weeks after treatment.

• HCT

  4 weeks after treatment.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: This study was based on patients with iron deficiency anemia caused by uterine leiomyoma and adenomyosis.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

ningzhou xue, master

CONTACT

13156212575; ningzhou.xue@leespharm.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: January 14, 2022
• Study Start: March 15, 2022
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: February 15, 2022

Record last verified: 2021-12