Patients With Iron Deficiency Anemia in GynecologyCSETEOIPOSNCT05192291
Clinical Study Evaluating the Efficacy of Iron Proteinsuccinylate Oral Solution（FERPLEX） in Women With Gynecologic Iron Deficiency Anemia
An observational study of Patients With Iron Deficiency Anemia in Gynecology, run by Lee's Pharmaceutical Limited.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Patients With Iron Deficiency Anemia in Gynecology
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2022to 15 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Adult, Older adult
Study population: Patients with iron deficiency anemia caused by uterine leiomyoma and adenomyosis in gynecology and obstetrics
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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).
Read the 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.
- Keywords
- Iron deficiency anemia,Gynecology
- Medical subject headings
- Anemia, Iron-Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
HB
The levels of hemoglobin in 1 week of treatment.
Measured: The first week of treatment
SF
The levels of serum ferritin in 1 week of treatment.
Measured: The first week of treatment
HB
The levels of hemoglobin in 4 week of treatment.
Measured: The fourth week of treatment
SF
The levels of serum ferritin in 4 week of treatment.
Measured: The fourth week of treatment
HB
The levels of hemoglobin in 8 week of treatment.
Measured: Eight weeks after treatment
SF
The levels of serum ferritin in 8 week of treatment.
Measured: Eight weeks after treatment
HB
The levels of hemoglobin in 12 weeks of treatment.
Measured: Twelve weeks after treatment
SF
The levels of serum ferritin in 12 weeks of treatment.
Measured: Twelve weeks after treatment
Secondary outcomes (12)
RBC
The levels of red blood cell in 1week of treatment.
Measured: 1 weeks after treatment.
HCT
The levels of hematocrit in 1week of treatment.
Measured: 1 weeks after treatment.
SI
The levels of free iron in 1week of treatment.
Measured: 1 weeks after treatment.
RBC
The levels of red blood cell in 4weeks of treatment.
Measured: 4 weeks after treatment.
HCT
The levels of hematocrit in 4weeks of treatment.
Measured: 4 weeks after treatment.
SI
The levels of free iron in 4 weeks of treatment.
Measured: 4 weeks after treatment.
RBC
The levels of red blood cell in 8 weeks of treatment.
Measured: 8 weeks after treatment.
HCT
The levels of hematocrit in 8 weeks of treatment.
Measured: 8 weeks after treatment.
SI
The levels of free iron in 8 weeks of treatment.
Measured: 8 weeks after treatment.
RBC
The levels of red blood cell in 12 weeks of treatment.
Measured: 12 weeks after treatment.
HCT
The levels of hematocrit in 12 weeks of treatment.
Measured: 12 weeks after treatment.
SI
The levels of free iron in 12 weeks of treatment.
Measured: 12 weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start15 Mar 2022 (estimated)
- Primary completion15 Mar 2023 (estimated)
- Study completion15 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Iron Deficiency Anemia in GynecologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192291
- Sponsor's protocol ID
- FPL-LEES-2021-12
- Acronym
- CSETEOIPOS
- Status last verified
- Dec 2021
- First submitted
- 6 Dec 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Efficacy of Iron Proteinsuccinylate Oral Solution（FERPLEX） in Women With Gynecologic Iron Deficiency Anemia
- ClinicalTrials.gov ID
- NCT05192291
- Acronym / sponsor ID
- CSETEOIPOS / FPL-LEES-2021-12
- Keywords
- Iron deficiency anemia,Gynecology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2022 (estimated)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 15 Mar 2023 (estimated)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients with iron deficiency anemia caused by uterine leiomyoma and adenomyosis in gynecology and obstetrics
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HB
Time frame: The first week of treatment
The levels of hemoglobin in 1 week of treatment.
SF
Time frame: The first week of treatment
The levels of serum ferritin in 1 week of treatment.
HB
Time frame: The fourth week of treatment
The levels of hemoglobin in 4 week of treatment.
SF
Time frame: The fourth week of treatment
The levels of serum ferritin in 4 week of treatment.
HB
Time frame: Eight weeks after treatment
The levels of hemoglobin in 8 week of treatment.
SF
Time frame: Eight weeks after treatment
The levels of serum ferritin in 8 week of treatment.
HB
Time frame: Twelve weeks after treatment
The levels of hemoglobin in 12 weeks of treatment.
SF
Time frame: Twelve weeks after treatment
The levels of serum ferritin in 12 weeks of treatment.
12 secondary outcomes
RBC
Time frame: 1 weeks after treatment.
HCT
Time frame: 1 weeks after treatment.
SI
Time frame: 1 weeks after treatment.
RBC
Time frame: 4 weeks after treatment.
HCT
Time frame: 4 weeks after treatment.
SI
Time frame: 4 weeks after treatment.
RBC
Time frame: 8 weeks after treatment.
HCT
Time frame: 8 weeks after treatment.
SI
Time frame: 8 weeks after treatment.
RBC
Time frame: 12 weeks after treatment.
HCT
Time frame: 12 weeks after treatment.
SI
Time frame: 12 weeks after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Iron Deficiency Anemia in Gynecology, run by Lee's Pharmaceutical Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ningzhou xue, master (13156212575 ext. 86, ningzhou.xue@leespharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HB (time frame: The first week of treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.