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

Hypothyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715572
• Other study ID #: T3T42008
• Secondary ID: T3T42005
• Status: Completed
• Phase: N/A
• First received: July 11, 2008
• Last updated: July 14, 2008
• Start date: March 2002
• Est. completion date: May 2004

Study information

• Verified date: July 2008
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypothyroidism

Intervention

Drug:
• thyroxine
monotherapy with thyroxine
• thyroxine and triiodothyronine
combination with thyroxine and triiodothyronine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biochemical parameters		the end of each period of treatment	No