Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/08/2004
Date assigned
28/07/2005
Last edited
21/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Héctor F Escobar-Morreale

ORCID ID

Contact details

Department of Endocrinology
Hospital Ramón y Cajal
Carretera de Colmenar km 9,1
Madrid
28034
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI27/99

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Hypothyroidism

Intervention

A randomized double-blind crossover design served to compare treatment with 100 µg of levothyroxine per day and treatment with a combination containing 75 µg of levothyroxine plus 5 µg of liothyronine per day, in periods of 8 weeks each. All the patients were also given a combination containing 87.5 µg of levothyroxine plus 7.5 µg of liothyronine per day for a final 8-week period add-on.

The function of the euthyroid healthy external control group was:
1. To evaluate the clinical meaningfulness of any changes detected between treatments in hypothyroid patients, given that subtle differences may be observed, but could not be important if patients were comparable to healthy people when on both treatments
2. To evaluate if patients perform worse than controls irrespective of the treatment applied

Intervention type

Drug

Phase

Not Specified

Drug names

Levothyroxine, liothyronine

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2000

Overall trial end date

31/05/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Inclusion criteria required women between 18 and 70 years-old, presenting with overt primary hypothyroidism as defined by increased thyroid-stimulating hormone (TSH) and decreased free T4 serum levels at diagnosis, who maintained serum TSH levels within the normal range on a stable levothyroxine dose of 100 µg per day for at least the previous year.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Exclusion criteria included mental illnesses, affective disorders or use of psychotropic drugs, cardiovascular, renal or hepatic disease, osteoporosis, and treatment with drugs that may interfere with thyroid function other than levothyroxine.

The external euthyroid control group was composed of healthy women.

Recruitment start date

01/04/2000

Recruitment end date

31/05/2005

Locations

Countries of recruitment

Spain

Trial participating centre

Department of Endocrinology
Madrid
28034
Spain

Sponsor information

Organisation

Hospital Ramón y Cajal, Madrid (Spain)

Sponsor details

Carretera de Colmenar km 9,1
Madrid
28034
Spain

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Predoctoral fellowships from the Consejería de Educación, Comunidad de Madrid (01/0430/01), and from the Fondo de Investigación Sanitaria (01/F072), Instituto de Salud Carlos III, Ministerio de Sanidad y Consumo, Spain, to one of the Authors. Financial aid came from Merck Darmstad KgaA, Germany.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes