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Sponsored by: |
The I.M. Sechenov Moscow Medical Academy |
Information provided by: | The I.M. Sechenov Moscow Medical Academy |
ClinicalTrials.gov Identifier: | NCT00715572 |
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 |
ChemIDplus related topics: | Levothyroxine Sodium Thyroxine Triiodothyronine Liothyronine sodium |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment |
Official Title: | Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone in the Treatment of Primary Hypothyroidism |
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 |
A: Active Comparator |
Drug: thyroxine
monotherapy with thyroxine
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B: Active Comparator |
Drug: thyroxine and triiodothyronine
combination with thyroxine and triiodothyronine
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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.
Ages Eligible for Study: | 18 Years to 48 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | The I.M. Sechenov Moscow Medical Academy, Department of Endocrinology ( The I.M. Sechenov Moscow Medical Academy, Department of Endocrinology ) |
Study ID Numbers: | T3T42008, T3T42005 |
First Received: | July 11, 2008 |
Last Updated: | July 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00715572 |
Health Authority: | Russia: Ethics Committee |
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