Clinical Trials

Numerous clinical trials spanning early phase through Phase IV evaluate Levothyroxine sodium across metabolic and endocrine conditions, including primary, congenital, postsurgical, and subclinical hypothyroidism, as well as thyroid cancer, alveolar soft part sarcoma, morbid obesity, and female infertility. Sponsored by pharmaceutical companies, academic medical centers, and government organizations, these studies assess bioequivalence, pharmacokinetic parameters, and neurocognitive outcomes. Recruitment statuses across these trials range from completed and actively recruiting to terminated or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06652113 RECRUITING
Recurrent Pregnancy Loss; Euthyroid With Thyroid Antibodies
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
 2024-11-15
NCT07380854 RECRUITING
Subclinical Hypothyroidism
Seoul National University Bundang Hospital
 2022-02-27
NCT07787585 NOT_YET_RECRUITING
Hypothyroidism
Spyridoula Maraka
 2027-10 PHASE4
NCT05316922 RECRUITING
Hypothyroidism; Irradiation
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
 2021-12-13 PHASE3
NCT07421869 RECRUITING
Hypothyroidism
Seoul National University Bundang Hospital
 2024-06-12
NCT07568574 ENROLLING_BY_INVITATION
Safety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite Athletes
Enhanced Emirates Limited
 2026-03-12
NCT06073665 RECRUITING
Hypothyroidism
University of Pennsylvania
 2024-01-31 PHASE4
NCT06731764 RECRUITING
Hypothyroidism
UConn Health
 2024-12-10 PHASE2; PHASE3
NCT06790589 NOT_YET_RECRUITING
Advanced Differentiated Thyroid Gland Carcinoma
AHS Cancer Control Alberta
 2026-12 PHASE2
NCT07239674 NOT_YET_RECRUITING
Intermediate-to-High Risk Differentiated Thyroid Cancer
West China Hospital
 2025-11-30 PHASE3
NCT07424183 NOT_YET_RECRUITING
Hypothyroidism Primary
University of Pennsylvania
 2026-11 PHASE2
NCT06345339 RECRUITING
Hypothyroidism
AbbVie
 2024-04-26 PHASE2; PHASE3
NCT07011953 NOT_YET_RECRUITING
Schizophrenia; Avolition
Peking University
 2025-07-01 EARLY_PHASE1
NCT07625722 NOT_YET_RECRUITING
Thyroid Function; Preterm; SGA and Growth; Neurodevelopment Outcome
Shandong Provincial Hospital
 2026-06-20
NCT07781514 ENROLLING_BY_INVITATION
Hypothyroidism
Bangladesh Medical University
 2027-02
NCT06999278 NOT_YET_RECRUITING
Abortion, Habitual
Women's Hospital School Of Medicine Zhejiang University
 2025-06-01 PHASE3
NCT06428097 RECRUITING
Heart Transplant Failure; Heart Transplant Infection
University of California, San Francisco
 2024-03-29 PHASE1
NCT06653907 NOT_YET_RECRUITING
Thyroid Abnormalities; Pregnant Woman; Pregnancy Outcomes
Yang ZHANG
 2024-10-25 PHASE4
NCT07323706 RECRUITING
Hypothyroidism Primary
University of Copenhagen
 2024-10-01
NCT06455371 RECRUITING
Hypothyroidism; Thyroid Cancer; Thyroid
University Hospital of North Norway
 2024-12-20
NCT07332273 RECRUITING
Obesity
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
 2025-11-05 PHASE3
NCT07754370 COMPLETED
Congenital Hypothyroidism
Menoufia University
 2025-11-02 PHASE4
NCT06373523 ACTIVE_NOT_RECRUITING
Hepatic Steato-Fibrosis; Non-Alcoholic Fatty Liver Disease
Post Graduate Institute of Medical Education and Research, Chandigarh
 2024-01-15 EARLY_PHASE1
NCT06041204 RECRUITING
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries; Subclinical Hypothyroidism; Female Infertility
Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy
 2021-05-06
NCT07393165 RECRUITING
Levothyroxine; Cardiac Function; Children; Subclinical Hypothyroidism
Tanta University
 2025-05-24
NCT03977207 RECRUITING
Thyroid; Functional Disturbance; Hypothyroidism; Hemodialysis
University of California, Irvine
 2020-07-20
NCT06660823 COMPLETED
Cardiac Surgery Intensive Care Treatment; Delayed Recovery From Anaesthesia; Euthyroid Sick Syndrome; Cardiac Surgery Requiring Cardiopulmonary Bypass
Ain Shams University
 2024-11-30 PHASE3
NCT05712421 COMPLETED
Hypothyroidism
Neuvosyn Laboratories, LLC
 2023-02-28 PHASE2
NCT05228184 TERMINATED
Congenital Hypothyroidism
IBSA Institut Biochimique SA
 2022-01-21 PHASE4
NCT06276205 COMPLETED
Hypothyroidism Primary; Lipid Disorder; Dyslipidemias
King Edward Medical University
 2024-03-01 PHASE3
NCT06625814 COMPLETED
Healthy
Merck Sharp & Dohme LLC
 2024-07-08 PHASE1
NCT05733078 UNKNOWN
Hypothyroidism; Primary Hypothyroidism; Vitamin C Deficiency
Dr Adnan Agha
 2023-11-01 PHASE2
NCT05823012 COMPLETED
Hypothyroidism
Xeris Pharmaceuticals
 2023-05-15 PHASE2
NCT06641440 COMPLETED
Recurrent Pregnancy Loss, Not Pregnant; Recurrent Implantation Failure
Centre for Endocrinology and Reproductive Medicine, Italy
 2018-01-01 PHASE4
NCT01391962 COMPLETED
Sarcoma, Alveolar Soft Part
National Cancer Institute (NCI)
 2011-07-18 PHASE2
NCT05412979 COMPLETED
Hypothyroidism
Sention Therapeutics, LLC
 2022-04-29 PHASE2
NCT01848171 UNKNOWN
Hypothyroidism; Thyroid Diseases; Endocrine System Diseases
Shandong Provincial Hospital
 2013-07 PHASE4
NCT06036576 COMPLETED
Recurrent Early Pregnancy Loss; Thyroid Diseases
Al-Kindy College of Medicine
 2022-03-01 PHASE3
NCT04782856 COMPLETED
Thyroid Goiter; Hypothyroidism; Thyroid Cancer
Virginia Commonwealth University
 2020-10-28 PHASE2
NCT04868045 WITHDRAWN
Thyroid Cancer
Memorial Sloan Kettering Cancer Center
 2021-04-27 PHASE1
NCT05240911 UNKNOWN
Thyroid Neoplasms; Hypothyroidism; Surgery
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2022-06-01
NCT04132622 UNKNOWN
Paraquat Poisoning
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2020-01-01 PHASE4
NCT04288115 COMPLETED
Subclinical Hypothyroidism
VA Office of Research and Development
 2021-03-24 PHASE4
NCT05421468 UNKNOWN
Hypothyroidism
King Abdullah International Medical Research Center
 2022-03-14
NCT04988802 UNKNOWN
Hypothyroidism Primary
University Hospital Dubrava
 2021-10-20
NCT06135948 COMPLETED
L-thyroxine
Emirates Health Services (EHS)
 2022-03-15 PHASE4
NCT01831869 UNKNOWN
Hypothyroidism; Thyroid Diseases; Endocrine System Diseases
Shandong Provincial Hospital
 2013-04 PHASE4
NCT04878614 TERMINATED
Hypothyroidism
University of California, Los Angeles
 2021-05-05 PHASE4
NCT04747275 TERMINATED
Hypothyroidism; Trisomy 21
Children's Mercy Hospital Kansas City
 2021-01-18 PHASE4
NCT04953195 UNKNOWN
Subclinical Hypothyroidisms
Beijing Chao Yang Hospital
 2019-01-01 PHASE4
NCT03053115 COMPLETED
Hypothyroidism
Azienda USL Modena
 2017-03-14 PHASE2; PHASE3
NCT03191188 UNKNOWN
Thyroid Disease; Kidney Diseases, Chronic
University of California, Irvine
 2017-07-01
NCT04124705 COMPLETED
Hypothyroidism; Thyroid Disease; Euthyroid; Thyroid Gland; Thyroid Hormones
Allergan
 2019-10-11 PHASE2
NCT04178928 UNKNOWN
Subclinical hypothyroïdism
Ain Shams University
 2020-01 PHASE1; PHASE2
NCT03391154 COMPLETED
Euthyroid Females
Ain Shams University
 2017-05-01 PHASE3
NCT03627611 COMPLETED
Hypothyroidism; Biomarkers; Endocrine System Diseases
Oslo University Hospital
 2018-08-14 PHASE2
NCT03094416 COMPLETED
Hypothyroidism;Postablative
IBSA Institut Biochimique SA
 2018-07-30 PHASE4
NCT02577367 WITHDRAWN
Hypothyroidism
Jocelyne Karam
 2015-10-01 PHASE4
NCT03606824 UNKNOWN
Dyslipidemia; Subclinical hypothyroïdism; Statin; ASCVD
Shaochun.Li
 2019-03-25
NCT03979274 COMPLETED
Healthy
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
 2019-12-06 PHASE1
NCT03614988 UNKNOWN
Aging; Primary Hypothyroidism; Interaction Drug Food
Hospital de Clinicas de Porto Alegre
 2018-05-01
NCT02946918 TERMINATED
Thyroid Cancer; Postsurgical Hypothyroidism
University of Texas Southwestern Medical Center
 2017-02-01 PHASE4
NCT04573907 COMPLETED
Healthy
Tecnoquimicas
 2019-06-01 PHASE4
NCT02399475 COMPLETED
Subclinical Hypothyroidism
University of Pennsylvania
 2015-01-01
NCT04037748 COMPLETED
Healthy
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
 2019-06-25 PHASE1
NCT03342001 COMPLETED
Hypothyroidism
University of Maryland, Baltimore
 2018-06-18 PHASE4
NCT03856970 COMPLETED
Healthy Volunteers
Ironwood Pharmaceuticals, Inc.
 2019-03-11 PHASE1
NCT03098433 COMPLETED
Healthy
Virginia Commonwealth University
 2017-10-20 PHASE1; PHASE2
NCT04037748 Completed
Healthy
Merck Healthcare KGaA Darmstadt Germany an affiliate of Merck KGaA Darmstadt Germany
 2019-06-25 Phase 1
NCT03096613 UNKNOWN
Heart Failure; Subclinical Hypothyroidism
Chinese Academy of Medical Sciences, Fuwai Hospital
 2017-04-18 PHASE4
NCT03898622 COMPLETED
Chronic Kidney Diseases; Subclinical Hypothyroidism
Hospital Civil de Guadalajara
 2018-10-01 PHASE3
NCT02512978 UNKNOWN
Myocardial Infarction; Hypothyroidism
Chinese Academy of Medical Sciences, Fuwai Hospital
 2015-08 PHASE4
NCT03634371 UNKNOWN
Healthy
Tecnoquimicas
 2018-08-10 PHASE4
NCT02317926 UNKNOWN
Hypothyroidism
Walter Reed National Military Medical Center
 2015-05
NCT02917863 UNKNOWN
Hypothyroidism
Meyer Children's Hospital IRCCS
 2016-05 PHASE4
NCT05371262 COMPLETED
Congenital Hypothyroidism
Federico II University
 2011-05 PHASE4
NCT01853579 COMPLETED
Subclinical Hypothyroidism; Depression
Insel Gruppe AG, University Hospital Bern
 2013-03 PHASE4
NCT02500342 COMPLETED
Thyroid Dysfunction; Mental Fatigue; Fatigue
Insel Gruppe AG, University Hospital Bern
 2014-01 PHASE4
NCT03115515 COMPLETED
Pregnancy Related; Thyroid
Medstar Health Research Institute
 2011-08
NCT03372772 UNKNOWN
Patient Compliance
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2017-03-16
NCT03106935 UNKNOWN
Recurrent Pregnancy Loss
Second Affiliated Hospital of Soochow University
 2015-07 EARLY_PHASE1
NCT01832753 COMPLETED
Down Syndrome; Subclinical Hypothyroidism
Children's Hospital of Philadelphia
 2013-01
NCT02548715 WITHDRAWN
Hypothyroidism; Neoplasms; Postoperative Complications
University of Alberta
 2015-07 PHASE2; PHASE3
NCT01465867 COMPLETED
Pregnancy; Infertility; Auto-immune Thyroiditis
University of Roma La Sapienza
 2012-04
NCT02920385 COMPLETED
Diabetes; Healthy
Novo Nordisk A/S
 2016-10-10 PHASE1
NCT01950260 COMPLETED
Graves' Disease
Mayo Clinic
 2013-09 PHASE2; PHASE3
NCT02832960 COMPLETED
Thyroid Dysfunction; Atherosclerosis; Heart Failure
Insel Gruppe AG, University Hospital Bern
 2016-06 PHASE4
NCT02211053 TERMINATED
Brain Dead Organ Donors
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
 2014-07 PHASE4
NCT02832934 COMPLETED
Thyroid Dysfunction; Atherosclerosis; Heart Failure
Insel Gruppe AG, University Hospital Bern
 2016-06 PHASE4
NCT02491008 COMPLETED
Thyroid Dysfunction; Bone Mineral Density; Osteoporosis; Fractures, Bone
Insel Gruppe AG, University Hospital Bern
 2014-01 PHASE4
NCT01660126 COMPLETED
Subclinical Hypothyroidism
NHS Greater Glasgow and Clyde
 2014-05 PHASE4
NCT03095963 COMPLETED
Hypothyroidism
Azienda USL Modena
 2014-01-01
NCT02186405 WITHDRAWN
Subclinical hypothyroïdism
Centre Hospitalier Universitaire de Nice
 2015-10 PHASE4
NCT03281083 TERMINATED
Non-Alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2
Duke-NUS Graduate Medical School
 2014-03-28 PHASE2
NCT02374593 COMPLETED
Congenital Hypothyroidism
Erica Eugster
 2014-03
NCT02329379 WITHDRAWN
Goiter
Sheng-Chiang Su
 2015-05 PHASE4
NCT00388297 COMPLETED
Subclinical Hypothyroidism; Hypothyroxinemia; Pregnancy
The George Washington University Biostatistics Center
 2006-10 PHASE3
NCT02332031 COMPLETED
Drug Interactions
Bayer
 2015-02 PHASE1
NCT02316743 UNKNOWN
Systolic Heart Failure; Sub-clinical Hypothyroidism
Université de Sherbrooke
 2014-12 PHASE4
NCT01707056 WITHDRAWN
Thyroid Carcinoma; Hypothyroidism
Medstar Health Research Institute
 2012-09
NCT01306227 COMPLETED
Hypothyroxinemia
Centre Hospitalier Universitaire, Amiens
 2006-09-01 PHASE3
NCT01744743 UNKNOWN
Hypothyroidism
Fudan University
 2011-01
NCT01379170 UNKNOWN
Diabetes; Hypothyroidism
Maastricht University Medical Center
 2011-06 PHASE4
NCT01647750 COMPLETED
Hypothyroidism
Newcastle-upon-Tyne Hospitals NHS Trust
 2012-08 PHASE4
NCT02570581 COMPLETED
Healthy
Centre Hospitalier Universitaire de Nice
 2014-06 PHASE1
NCT01916304 COMPLETED
Hypothyroidism
Takeda
 2013-07 PHASE2
NCT01739972 UNKNOWN
Primary Hypothyroidism.
Walter Reed National Military Medical Center
 2012-05
NCT02090907 COMPLETED
Subclinical Hypothyroidism
Isfahan University of Medical Sciences
 2013-05 PHASE2; PHASE3
NCT01631305 COMPLETED
Euthyroid Sick Syndrome
Sinaloa Pediatric Hospital
 2012-01 PHASE4
NCT03102177 COMPLETED
Hypothyroidism Primary
Georgetown University
 2011-05-31 EARLY_PHASE1
NCT00106119 COMPLETED
Thyroid Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2005-03 PHASE2
NCT01486667 UNKNOWN
Dyslipidemia
King Saud University
 2011-10 PHASE3
NCT00565864 COMPLETED
Hypothyroidism
Oregon Health and Science University
 2008-08 PHASE4
NCT01769157 COMPLETED
Hypothyroidism
Korea University Anam Hospital
 2012-08 PHASE4
NCT02499471 COMPLETED
Hypothyroidism; Hyperthyroidism; Obesity
Maastricht University Medical Center
 2012-03
NCT04528797 COMPLETED
Brain Death
Medical University of South Carolina
 2010-09-02
NCT01536678 COMPLETED
Hypothyroidism
GlaxoSmithKline
 2012-01 PHASE4
NCT00921050 COMPLETED
Subclinical Hypothyroidism
Universidad Autonoma de Nuevo Leon
 2009-06 PHASE2; PHASE3
NCT01276782 WITHDRAWN
Systemic Lupus Erythematosus
Johns Hopkins University
 2011-01 PHASE4
NCT00230802 COMPLETED
Pregnancy; Hypothyroidism
Brigham and Women's Hospital
 2005-07
NCT01189344 COMPLETED
Morbid Obesity
University of Sao Paulo
 2007-09
NCT00488644 TERMINATED
Hypothyroidism; Brain Tumor
M.D. Anderson Cancer Center
 2006-02
NCT00403390 COMPLETED
Congenital Hypothyroidism; Hypothyroidism
Boston Children's Hospital
 2006-11
NCT00277589 COMPLETED
Goiter, Nodular
Sanofi
 2004-05 PHASE4
NCT00552253 COMPLETED
Thyroid Nodule
National Taiwan University Hospital
 2007-10
NCT01528839 COMPLETED
Bipolar Disorder
Charite University, Berlin, Germany
 2004-03 PHASE2; PHASE3
NCT00846755 COMPLETED
Thyroid Disease; Pregnancy
Ospedale V. Fazzi
 2005-03
NCT00648882 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2007-03 PHASE1
NCT00524238 COMPLETED
Hypothyroidism
University of Aarhus
 2004-03
NCT00648700 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2005-08 PHASE1
NCT00715572 COMPLETED
Hypothyroidism
I.M. Sechenov First Moscow State Medical University
 2002-03
NCT01465646 COMPLETED
Pharmacokinetics
Heidelberg University
 2003-06 PHASE1
NCT01465633 COMPLETED
Pharmacokinetics
Heidelberg University
 2003-08 PHASE1
NCT00647855 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2003-05 PHASE1
NCT00648557 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2003-01 PHASE1
NCT00535561 COMPLETED
Iron Deficiency Anemia; Subclinical Hypothyroidism
Duzce University
 2007-06 PHASE1
NCT00498238 COMPLETED
Subclinical Hypothyroidism
Assaf-Harofeh Medical Center
 2003-07

(data from https://clinicaltrials.gov, updated on 2025-09-23)

Check the Levothyroxine (L-Thyroxine) sodium product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Levothyroxine sodium acts as a selective agonist of thyroid hormone receptors alpha and beta, binding to nuclear receptors to modulate the expression of genes governing cellular energy metabolism and oxygen consumption. This transcriptional activation restores physiological thyroid hormone signaling, directly reversing metabolic deficits in patient populations evaluated for clinical and subclinical hypothyroidism.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.