Trial · NCT00403390
Generic vs. Name-Brand Levothyroxine
NCT00403390, Not applicable, Completed, Boston Children's Hospital; results first posted 2018-02-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Generic vs. Name-Brand Levothyroxine. Trials, record NCT00403390. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00403390
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Generic vs. Name-Brand Levothyroxine
- NCT number
- NCT00403390
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 34 participants, actual
- Lead sponsor
- Boston Children's Hospital
- Conditions
- Congenital Hypothyroidism, Hypothyroidism
- Interventions
- Brand Name Levothyroxine (Synthroid), Generic formulation of Levothyroxine
- First posted
- 2006-11-23
- Last updated
- 2018-02-23
- Results first posted
- 2018-02-23
- Limitations and caveats
- Proof of principle study; small sample. Results may not be applicable to all populations.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Thyroid Stimulating Hormone as Primary Endpoint Measured at Initiation of Study, After 8 Weeks of One Drug, and Then 8 Weeks After the Second Drug. | 3 points over 16 weeks |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Thyroid Stimulating Hormone as Primary Endpoint Measured at Initiation of Study, After 8 Weeks of One Drug, and Then 8 Weeks After the Second Drug. | 3 points over 16 weeks | uIU/mL | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Thyroid Stimulating Hormone as Primary Endpoint Measured at Initiation of Study, After 8 Weeks of One Drug, and Then 8 Weeks After the Second Drug. | Group 1 | Baseline | 2.455 | Standard Error 1.532 | uIU/mL |
| Thyroid Stimulating Hormone as Primary Endpoint Measured at Initiation of Study, After 8 Weeks of One Drug, and Then 8 Weeks After the Second Drug. | Group 2 | Baseline | 2.131 | Standard Error 1.322 | uIU/mL |
| Thyroid Stimulating Hormone as Primary Endpoint Measured at Initiation of Study, After 8 Weeks of One Drug, and Then 8 Weeks After the Second Drug. | Group 1 | After first drug | 0.788 | Standard Error 0.631 | uIU/mL |
| Thyroid Stimulating Hormone as Primary Endpoint Measured at Initiation of Study, After 8 Weeks of One Drug, and Then 8 Weeks After the Second Drug. | Group 2 | After first drug | 3.053 | Standard Error 1.233 | uIU/mL |
| Thyroid Stimulating Hormone as Primary Endpoint Measured at Initiation of Study, After 8 Weeks of One Drug, and Then 8 Weeks After the Second Drug. | Group 1 | After second drug | 3.112 | Standard Error 4.983 | uIU/mL |
| Thyroid Stimulating Hormone as Primary Endpoint Measured at Initiation of Study, After 8 Weeks of One Drug, and Then 8 Weeks After the Second Drug. | Group 2 | After second drug | 1.217 | Standard Error 2.832 | uIU/mL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 | 16 | |
| Overall Study | STARTED | Group 2 | 18 | |
| Overall Study | COMPLETED | Group 1 | 13 | |
| Overall Study | COMPLETED | Group 2 | 18 | |
| Overall Study | NOT COMPLETED | Group 1 | 3 | |
| Overall Study | NOT COMPLETED | Group 2 | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 | 0 | 13 |
| Total, all-cause mortality | Group 2 | 0 | 18 |
| Total, other adverse events | Group 1 | 0 | 13 |
| Total, other adverse events | Group 2 | 0 | 18 |
| Total, serious adverse events | Group 1 | 0 | 13 |
| Total, serious adverse events | Group 2 | 0 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23264396 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1 vs Group 2: deaths from any cause | Trial comparisons |
| Group 1 vs Group 2: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00403390
GET https://conductscience.org/api/trials/v1/NCT00403390/registered