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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

July 11, 2008
July 14, 2008
March 2002
February 2004   (final data collection date for primary outcome measure)
biochemical parameters [ Time Frame: the end of each period of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00715572 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypothyroidism
  • Drug: thyroxine
    monotherapy with thyroxine
  • Drug: thyroxine and triiodothyronine
    combination with thyroxine and triiodothyronine
  • Active Comparator: A
    Intervention: Drug: thyroxine
  • Active Comparator: B
    Intervention: Drug: thyroxine and triiodothyronine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
May 2004
February 2004   (final data collection date for primary outcome measure)

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.
Female
18 Years to 48 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00715572
T3T42008, T3T42005
No
The I.M. Sechenov Moscow Medical Academy, Department of Endocrinology
The I.M. Sechenov Moscow Medical Academy
Not Provided
Principal Investigator: Valentin V Fadeyev Moscow Medical Academy, Department of Endocrinology
The I.M. Sechenov Moscow Medical Academy
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP