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
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