Hypothyroidism MedDRA version: 20.0 Level: LLT Classification code 10045920 Term: Unspecified hypothyroidism System Organ Class: 100000004860
Conditions
Interventions
Product Name: Dissicated thyroid extract
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Thyroid
CAS Number: 8028-36-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
Birte Nygaard, Dept of Endocrinology, Herelv Hosptial, University og Copenhagen,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Hypothyroidism, defined as s-TSH>4,8mU/l measured at least twice, before initial therapy is given. • Stabile s-TSH within normal reference range for a minimum of 6 month and still having persistent symptoms similar to hypothyroidism, with no other explanation for these symptoms. • Due to the persistent symptoms treated with L-T4/L-T3 combination therapy in a ration similar to human levels app. 1:17 • Having effect on QoL and hypothyroid symptom persisting for a minimum of 12 month • S- TSH levels 0,1- 4,8mU/l This group is chosen to reach the selected group of patients with a possible need supplementary therapy than l-T4 – in which other explanations of the symptoms have been ruled out. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous thyroid cancer Previous hyperthyroidism Postpartum thyroiditis not having a period of reduction/ discontinuing T4 therapy Pregnant or plan for being pregnant within the next year Reduced Danish skills
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this project is to characteristic the subset of patients, not responding to L-T4 therapy and to compare combination LT4+LT3 therapy to therapy with DTE to determine if a difference is present between these therapies evaluated by effect as well as side effect. Hereby, we can bring new evidence, and if an effect of DTE are superior to L-T4/L-T3 therapy and without increased risks of side effect advocate for the introduction of this therapy in Danish and international guidelines and increase the options individualized therapy for hypothyroidism.;Secondary Objective: not applicaple;Primary end point(s): Preference of DTE vs L-T4/L-T3 combination therapy;Timepoint(s) of evaluation of this end point: end of study - 8 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Quality of Life (QoL) evaluated by a thyroid specific QoL questionnaire (Thy-PRO), changes in thyroid function parameters (TSH, total and free T4 and T3), lipid and diabetes status and body composition (lean mass, fat mass). Heart rate (integrated and arrhythmias (evaluated by 24 hours continuedly monitoring at home (Holter monitoring) , Changes in bone metabolism markers (PINP,CTX) calcium metabolism and bone mineral density;Timepoint(s) of evaluation of this end point: Qol will be evaluated every 4 week Otherwise parameters will be measured before and after each treatment period | — |
Countries
Denmark
Contacts
Public ContactDepartment of endocrinology
Herlev Hospital, University of Copenhagen
Outcome results
None listed