Comparison of the hormonal responses to Levothyroxin made by Aburaihan company with Levothyroxine made by Merck company

Non-inferiority Randomized Controlled Clinical Trial of the hormonal responses to Levothyroxin made by Aburaihan company and Levothyroxine made by Merck company

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220307054211N1

Enrollment

Registered

2022-05-15

Start date

2022-07-11

Completion date

Unknown

Last updated

2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothyroidism. Hypothyroidism, unspecified

Interventions

Intervention 1: Intervention group number one: This group will receive Levothyroxine pills made by Merck company. They will take 1.6 micro-gram per kg daily before breakfast for eight weeks. Intervent

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: New patients with Hypothyroidism: serum TSH level should be 5.06-19.9 mIU/L and serum FT4 less than 0.91 ng/dL. Only new patients who have never taken thyroid treatment.

Exclusion criteria

Exclusion criteria: Pregnant women People with underlying diseases such as liver failure, renal failure, heart failure People with co-factors that can simulate hypothyroidism symptoms: Low Hgb, Vitamin D and B12 deficiency, and Depression Taking any of the following medications during the trial: Methimazole, PTU, Tamoxifen, Drugs containing Estrogen and Progesterone, Corticosteroid, Gastrointestinal medication

Design outcomes

Primary

Measure	Time frame
Changes of serum TSH level. Timepoint: First day, 6 weeks and 8 weeks after intervention. Method of measurement: Serum TSH and FT4 will be determined on blood samples by the Electrochemiluminescence immunoassay (ECLIA) method, using Roche Diagnostics kits and Roche/Hitachi Cobas e-411 analyzer (GmbH, Mannheim, Germany).;Changes of serum FT4 level. Timepoint: First day, 6 weeks and 8 weeks after intervention. Method of measurement: Serum TSH and FT4 will be determined on blood samples by the Electrochemiluminescence immunoassay (ECLIA) method, using Roche Diagnostics kits and Roche/Hitachi Cobas e-411 analyzer (GmbH, Mannheim, Germany).	—

Measure

Time frame

Changes of serum TSH level. Timepoint: First day, 6 weeks and 8 weeks after intervention. Method of measurement: Serum TSH and FT4 will be determined on blood samples by the Electrochemiluminescence immunoassay (ECLIA) method, using Roche Diagnostics kits and Roche/Hitachi Cobas e-411 analyzer (GmbH, Mannheim, Germany).;Changes of serum FT4 level. Timepoint: First day, 6 weeks and 8 weeks after intervention. Method of measurement: Serum TSH and FT4 will be determined on blood samples by the Electrochemiluminescence immunoassay (ECLIA) method, using Roche Diagnostics kits and Roche/Hitachi Cobas e-411 analyzer (GmbH, Mannheim, Germany).

—

Secondary

Measure	Time frame
Thyroid symptoms. Timepoint: At the first and last visits. Method of measurement: Thyroid symptom questionnaire (TSQ).;Treatment satisfaction. Timepoint: At the first and last visits. Method of measurement: Treatment satisfaction questionnaire (THY-TSQ).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAtieh Amouzegar

Shahid Beheshti University of Medical Sciences

amouzegar@endocrine.ac.ir+98 21 2243 2500

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026