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

I

I.M. Sechenov First Moscow State Medical University

Status

Completed

Conditions

Hypothyroidism

Treatments

Drug: thyroxine and triiodothyronine
Drug: thyroxine

Study type

Interventional

Funder types

Other

Identifiers

NCT00715572
T3T42008
T3T42005

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

Female

Ages

18 to 48 years old

Volunteers

No Healthy Volunteers

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.

Trial design

36 participants in 2 patient groups

A
Active Comparator group
Treatment:
Drug: thyroxine
B
Active Comparator group
Treatment:
Drug: thyroxine and triiodothyronine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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