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Clinical Trials in Poland / NCT05468554
Recruiting Phase 3

Evaluation of Metformin Effect on the Fertility of Women Treated With 131I for Thyroid Cancer

NCT05468554 · tracked via the Priya Life Science Poland tracker
Sponsor
Medical University of Bialystok
Phase
Phase 3
Started
2022-11-01
Last updated
2026-10-21

Condition(s) studied

Thyroid Cancer

Investigational drug(s) / intervention(s)

metformin →Radioactive iodine (I-131)

metformin: Metformin will be used 3 times a day (3x500mg), starting in the first week with 1x1 tablet (1x500 mg for breakfast), in the second week, 2x1 tablet (500 mg for breakfast and 500 mg for dinner), from the 3rd week 3x1 tablet. (3x500mg with main meals). A gradual escalation of the dose is planned to the point of developing drug intolerance or toxicity that is unacceptable to the patient.

Radioactive iodine (I-131): Patients qualified to receive 131I treatment

Study summary

This study is aimed to investigate the metformin effect on the fertility of women treated with 131 I for thyroid cancer

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria: 1. Female subjects in reproductive age \>18 \<45 years. 2. Subjects with diagnosed papillary thyroid carcinoma with various pathological stage TNM (I-II). 3. Subjects not treated with 131I 4. Willingness to comply with protocol procedures. Exclusion Criteria: 1. Hypersensitivity to metformin. 2. Subjects with polycystic ovarian syndrome or other diseases of the ovaries (primary / secondary ovarian failure). 3. Subjects taking metformin during last week. 4. Subjects with liver malfunction and abnormal hepatitis marker results (ALT and AST activity \>3ULN.\* 5. Subjects with eGFR below 45ml/min/1.73m2.\* 6. Subjects with lactic acidosis or having history of metabolic acidosis. 7. Subjects with serum AMH concentration\* below lower range norm. 8. Subjects with history of congestive heart disease NYHA stage III/IV. 9. Subjects with acute myocardial ischemia (CCS 3-4). 10. Subjects with history of sepsis or severe infection. 11. Subject with lung disease (uncontrolled asthma based on GINA 2000 Guidelines and COPD GOLD ≥ 3 stage). 12. Positive result of pregnancy test or pregnancy planned during the study. 13. Alcohol or other substance dependent syndromes. 14. BMI \<18.5 kg/m2. 15. Accompanying diseases with poor prognosis in the opinion of the researcher. 16. As per Investigator (or his designee) judgement, subject cannot participate in the study due to reasons (i.e. medical, psychiatric and/or social reason). 17. Unreliability or lack of cooperation. \*based on the laboratory results from screening visit

Primary outcome measure(s)

  • Changes in AMH, Inhibin B and FSH levels due to the action of metformin — 4 years
    The primary endpoint will be to evaluate the effect of metformin on the difference in serum AMH, inhibin B and FSH concentration and the number of antral follicles, assessed in the study groups consisted of the women with papillary thyroid cancer, treated with 131I, comparing received results during the randomized, V3, V4, V5 and V6 visits

Trial sites (2)

FacilityCityRegionStatus
Department of Endocrinology, Diabetology and Internal Medicine, Medical Univeristy of Bialystok Bialystok Poland Recruiting
Holy Cross Cancer Center Kielce Świetokrzystie Recruiting

On this site

📄 Glucophage (metformin) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05468554 on ClinicalTrials.gov ↗ ← All trials in Poland