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Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone

Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone in the Treatment of Primary Hypothyroidism

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00715572
Enrollment
36
Registered
2008-07-15
Start date
2002-03-31
Completion date
2004-05-31
Last updated
2008-07-15

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

Conditions

Hypothyroidism

Keywords

hypothyroidism, treatment, thyroxine, triiodothyronine

Brief summary

The objective of this study was to analyze the features of monotherapy with L-T4 in comparison with combined therapy with L-T4 and L-T3 in patients with primary hypothyroidism.

Detailed description

We conducted a randomized controlled study with a crossover design in 36 premenopausal women with overt primary hypothyroidism (reduced T4 concentration accompanied by increased TSH concentration at the time of initial diagnosis) who did not receive thyroid hormones. All patients were divided into two groups: patients from Group A (n=20) were randomized to L-T4 in dose of 1,6 μg per kg, followed by combined L-T4 and L-T3; and 16 women from Group B received the combination of L-T4+L-T3 (the dose of L-T4 was reduced by 25 μg and replaced with 12,5 μg of L-T3), followed by monotherapy with L-T4. The treatment periods lasted for 6 months. Patients were examined at baseline and at the end of each treatment period.Blood samples were obtained to measure serum TSH, free T4, free T3, lipid profile, osteocalcin. Urine samples were collected to measure urinary deoxypyridinoline / creatinine ratio. 24-hour ECG-monitoring, osteodensitometry and psychological testing were also performed at baseline and at the end of each treatment period.

Interventions

monotherapy with thyroxine

DRUGthyroxine and triiodothyronine

combination with thyroxine and triiodothyronine

Sponsors

I.M. Sechenov First Moscow State Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
No

Inclusion criteria

* Premenopausal women with overt primary hypothyroidism (reduced T4 concentration accompanied by increased TSH concentration at the time of initial diagnosis) who did not receive thyroid hormones

Exclusion criteria

* Peri- and postmenopause * Pregnancy * Major comorbidity * Use of drugs that affect metabolism or bioavailability of thyroid hormones preparations.

Design outcomes

Primary

MeasureTime frame
biochemical parametersthe end of each period of treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026