HypothyroidismNCT00715572
Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone
A study testing thyroxine and thyroxine and triiodothyronine in people with Hypothyroidism, run by I.M. Sechenov First Moscow State Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- thyroxine and thyroxine and triiodothyronine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Mar 2002to May 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Peri- and postmenopause
- Pregnancy
- Major comorbidity
- Use of drugs that affect metabolism or bioavailability of thyroid hormones preparations.
About this study
Official title: Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone in the Treatment of Primary Hypothyroidism
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.
Read the detailed description
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
- Hypothyroidism
- Being tested
- thyroxine, thyroxine and triiodothyronine
- Keywords
- hypothyroidism, treatment, thyroxine, triiodothyronine
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thyroxineDrug
monotherapy with thyroxine
thyroxine and triiodothyronineDrug
combination with thyroxine and triiodothyronine
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: thyroxine |
| B | Active comparator | Not described Receives: Drug: thyroxine and triiodothyronine |
What is being measured
The primary outcome is the main question the study is designed to answer.
biochemical parameters
Measured: the end of each period of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startMar 2002
- Primary completionFeb 2004
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Valentin V Fadeyev, Principal investigator, Moscow Medical Academy, Department of Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715572
- Sponsor's protocol ID
- T3T42008
- Other IDs
- T3T42005
- Status last verified
- Jul 2008
- First submitted
- 11 Jul 2008
- Last updated
- 15 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone in the Treatment of Primary Hypothyroidism
- ClinicalTrials.gov ID
- NCT00715572
- Acronym / sponsor ID
- T3T42008
- Conditions
- Hypothyroidism
- Keywords
- hypothyroidism, treatment, thyroxine, triiodothyronine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- Mar 2002
- Primary completion
- Feb 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: thyroxine |
| B | Active comparator | Drug: thyroxine and triiodothyronine |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- Peri- and postmenopause
- Pregnancy
- Major comorbidity
- Use of drugs that affect metabolism or bioavailability of thyroid hormones preparations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thyroxinemonotherapy with thyroxine | Drug | A |
| thyroxine and triiodothyroninecombination with thyroxine and triiodothyronine | Drug | B |
Primary outcome
biochemical parameters
Time frame: the end of each period of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentin V Fadeyev principal investigator
Moscow Medical Academy, Department of Endocrinology
Questions about this trial
What is this clinical trial studying?
A study testing thyroxine and thyroxine and triiodothyronine in people with Hypothyroidism, run by I.M. Sechenov First Moscow State Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biochemical parameters (time frame: the end of each period of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2008.