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

NCT ID: NCT00715572

Last Updated: 2008-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2004-05-31

Brief Summary

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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

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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.

Conditions

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Hypothyroidism

Keywords

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hypothyroidism, treatment, thyroxine, triiodothyronine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type ACTIVE_COMPARATOR

thyroxine

Intervention Type DRUG

monotherapy with thyroxine

B

Group Type ACTIVE_COMPARATOR

thyroxine and triiodothyronine

Intervention Type DRUG

combination with thyroxine and triiodothyronine

Interventions

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thyroxine

monotherapy with thyroxine

Intervention Type DRUG

thyroxine and triiodothyronine

combination with thyroxine and triiodothyronine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role lead

Responsible Party

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The I.M. Sechenov Moscow Medical Academy, Department of Endocrinology

Principal Investigators

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Valentin V Fadeyev

Role: PRINCIPAL_INVESTIGATOR

Moscow Medical Academy, Department of Endocrinology

Other Identifiers

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T3T42005

Identifier Type: -

Identifier Source: secondary_id

T3T42008

Identifier Type: -

Identifier Source: org_study_id