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

This study has been completed.
Sponsor:
Information provided by:
The I.M. Sechenov Moscow Medical Academy
ClinicalTrials.gov Identifier:
NCT00715572
First received: July 11, 2008
Last updated: July 14, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention
Hypothyroidism
Drug: thyroxine
Drug: thyroxine and triiodothyronine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone in the Treatment of Primary Hypothyroidism

Resource links provided by NLM:


Further study details as provided by The I.M. Sechenov Moscow Medical Academy:

Primary Outcome Measures:
  • biochemical parameters [ Time Frame: the end of each period of treatment ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: March 2002
Study Completion Date: May 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: thyroxine
monotherapy with thyroxine
Active Comparator: B Drug: thyroxine and triiodothyronine
combination with thyroxine and triiodothyronine

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.

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00715572

Sponsors and Collaborators
The I.M. Sechenov Moscow Medical Academy
Investigators
Principal Investigator: Valentin V Fadeyev Moscow Medical Academy, Department of Endocrinology
  More Information

No publications provided

Responsible Party: The I.M. Sechenov Moscow Medical Academy, Department of Endocrinology
ClinicalTrials.gov Identifier: NCT00715572     History of Changes
Other Study ID Numbers: T3T42008, T3T42005
Study First Received: July 11, 2008
Last Updated: July 14, 2008
Health Authority: Russia: Ethics Committee

Keywords provided by The I.M. Sechenov Moscow Medical Academy:
hypothyroidism, treatment, thyroxine, triiodothyronine

Additional relevant MeSH terms:
Hypothyroidism
Endocrine System Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on November 20, 2014