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

Primary Purpose

Hypothyroidism

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
thyroxine
thyroxine and triiodothyronine
Sponsored by
I.M. Sechenov First Moscow State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothyroidism focused on measuring hypothyroidism, treatment, thyroxine, triiodothyronine

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    A

    B

    Arm Description

    Outcomes

    Primary Outcome Measures

    biochemical parameters

    Secondary Outcome Measures

    Full Information

    First Posted
    July 11, 2008
    Last Updated
    July 14, 2008
    Sponsor
    I.M. Sechenov First Moscow State Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00715572
    Brief Title
    Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone
    Official Title
    Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone in the Treatment of Primary Hypothyroidism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2002 (undefined)
    Primary Completion Date
    February 2004 (Actual)
    Study Completion Date
    May 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    I.M. Sechenov First Moscow State Medical University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypothyroidism
    Keywords
    hypothyroidism, treatment, thyroxine, triiodothyronine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Active Comparator
    Arm Title
    B
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    thyroxine
    Intervention Description
    monotherapy with thyroxine
    Intervention Type
    Drug
    Intervention Name(s)
    thyroxine and triiodothyronine
    Intervention Description
    combination with thyroxine and triiodothyronine
    Primary Outcome Measure Information:
    Title
    biochemical parameters
    Time Frame
    the end of each period of treatment

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    48 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Valentin V Fadeyev
    Organizational Affiliation
    Moscow Medical Academy, Department of Endocrinology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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