A Study to Investigate the Switch from Thyronorm or Eltroxin Tablet to Lethyrox Tablet in Patients withPrimary Hypothyroidism.

Phase 4

• Conditions: Health Condition 1: E039- Hypothyroidism, unspecified

• Registration Number: CTRI/2022/05/042396
• Lead Sponsor: Intas Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply-1 Must sign an ICF indicating that the participant understands the purpose of, and procedures

required for the study in this protocol and is willing to participate in the study.2 Man or woman participant must be between 18 to 65 years of age (both inclusive), at the time of signing the informed consent.3 Participants who are medically stable on the basis of physical examination, medical history, vital signs and 12-lead ECG performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant source documents and initialed by the investigator.4 Participants who are medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum biochemistry panel and hematology are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the

participant source documents and initialed by the investigator.5 Participants diagnosed with primary hypothyroidism for at least 1 year duration from screening visit.6 Participant must be stabilized on the same morning dose of Thyronorm or Eltroxin (a single daily tablet at either of following dose strength only-25,50,75,88,100,125,150 microgram) for at least last 8 weeks before screening visit.7 Participant must have TSH levels within the normal reference range as defined below (must be within 7 days of Baseline visit)-a TSH-0.465 to 4.68 mIU/mL.8 A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies-•Is not a woman of childbearing potential (WOCBP) OR•Is a WOCBP and using an acceptable contraceptive method during the intervention period. The investigator should evaluate the effectiveness and the potential for contraceptive method failure(e.g.,noncompliance, recently initiated)of the contraceptive method in relationship to the first dose of study intervention.Note: WOCBP already using hormonal contraceptive method should continue same throughout the study. WOCBP currently not using any hormonal contraceptive method should use the acceptable contraceptive method except hormonal contraceptives throughout the study.•A WOCBP must have a negative highly sensitive pregnancy test(Serum pregnancy test at screening).•Additional requirements for pregnancy testing during and after study intervention The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.9 Willing and able to adhere to the lifestyle restrictions specified in this protocol.

Exclusion Criteria

Any potential participant who meets any of the following criteria will be excluded from participatingin the study-1 Documented medical history of clinically significant cardiac, renal, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances or any other medical condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.2 Known allergies, hypersensitivity, or intolerance to Lethyrox tablet or its excipients.3 Had major surgery, (e.g., requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the

participant is expected to participate in the study.

NOTE-Participants with planned surgical procedures to be conducted under local anesthesia may participate.4 Participants with thyrotoxicosis.5Taken any disallowed therapies before the planned first dose of study intervention.6 Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years,carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence.7 Uncontrolled blood pressure (BP) with or without antihypertensive medications, defined as systolic more than 160 mm Hg or diastolic more than 100 mm Hg at screening.8 Past use of over-the-counter or prescription medication including herbal medications within

8 weeks prior to baseline (except those which are regularly taken by participants for any ongoing medical condition which is found acceptable by Investigator to enroll into the study).9 Received an investigational intervention including investigational vaccines or used an invasive investigational medical device within 5 half-lives prior to baseline or is currently enrolled in an investigational study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the impact of switch from Thyronorm or Eltroxin tablet to Lethyrox tablet on serum TSH levels in participants with primary hypothyroidism who are stable on Thyronorm or Eltroxin.Timepoint: Proportion of participants that obtained serum TSH within normal reference range after switch at 6 weeks.

Secondary Outcome Measures

Name	Time	Method
To characterize the impact of switch from Thyronorm or Eltroxin tablet to Lethyrox tablet on thyroid function tests in participants with <br/ ><br>primary hypothyroidism who are stable on Thyronorm or Eltroxin.Timepoint: â?¢Proportion of participants that obtained serum TSH within normal reference range after switch at 12 weeks and 18 weeks.â?¢ Absolute change from baseline of serum TSH values after switch at 6 weeks, 12 <br/ ><br>weeks and 18 weeks.â?¢Relative percent change from baseline of <br/ ><br>serum TSH values after switch at 6 weeks,12 weeks and 18 weeks