NCT00715572

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2002

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed
Last Updated

July 15, 2008

Status Verified

July 1, 2008

Enrollment Period

1.9 years

First QC Date

July 11, 2008

Last Update Submit

July 14, 2008

Conditions

Hypothyroidism

Keywords

hypothyroidism, treatment, thyroxine, triiodothyronine

Outcome Measures

Primary Outcomes (1)

  • biochemical parameters

    the end of each period of treatment

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: thyroxine

B

ACTIVE COMPARATOR
Drug: thyroxine and triiodothyronine

Interventions

thyroxineDRUG

monotherapy with thyroxine

A
thyroxine and triiodothyronineDRUG

combination with thyroxine and triiodothyronine

B

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Peri- and postmenopause
  • Pregnancy
  • Major comorbidity
  • Use of drugs that affect metabolism or bioavailability of thyroid hormones preparations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypothyroidism

Interventions

ThyroxineTriiodothyronine

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsThyronines

Study Officials

  • Valentin V Fadeyev

    Moscow Medical Academy, Department of Endocrinology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2008

First Posted

July 15, 2008

Study Start

March 1, 2002

Primary Completion

February 1, 2004

Study Completion

May 1, 2004

Last Updated

July 15, 2008

Record last verified: 2008-07