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NCT05192291: CSETEOIPOS
Clinical Study Evaluating the Efficacy of Iron Proteinsuccinylate Oral Solution（FERPLEX） in Women With Gynecologic Iron Deficiency Anemia
trial in Patients With Iron Deficiency Anemia in Gynecology in 240 participants. Status unknown.
15 March 2023
Quick facts
| Lead sponsor | Lee's Pharmaceutical Limited |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 240 |
| Start date | 15 March 2022 |
| Primary completion | 15 March 2023 |
| Estimated completion | 15 March 2023 |
Conditions studied
- Patients With Iron Deficiency Anemia in Gynecology — all drugs for Patients With Iron Deficiency Anemia in Gynecology →
Sponsor
Lee's Pharmaceutical Limited — full company profile →
Who can join
Adults 18 to 65, female only, with Patients With Iron Deficiency Anemia in Gynecology. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05192291
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05192291 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lee's Pharmaceutical Limited
- Last refreshed: 15 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05192291.
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