Trial · NCT03123913
Study of Testosterone and rHGH in FSHD
NCT03123913, Phase 1, Completed, University of Rochester; results first posted 2023-05-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Testosterone and rHGH in FSHD. Trials, record NCT03123913. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03123913
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Testosterone and rHGH in FSHD
- NCT number
- NCT03123913
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 20 participants, actual
- Lead sponsor
- University of Rochester
- Conditions
- Facioscapulohumeral Muscular Dystrophy
- Interventions
- Testosterone Enanthate, Somatropin
- First posted
- 2017-04-21
- Last updated
- 2023-05-16
- Results first posted
- 2023-05-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced an AE | 36 weeks | AEs were collected through patient report, interval laboratory studies, resting echocardiograms, dual energy x-ray absorptiometry (DEXA) studies, and physical examinations. |
| Secondary | Mean Change in Level of Free Testosterone in the Blood | Baseline to 24 weeks | |
| Secondary | Mean Change in Level of Total Testosterone in the Blood | Baseline to 24 weeks | |
| Secondary | Mean Change in Level of IGF-1 in the Blood | Baseline to 24 weeks | |
| Secondary | Mean Change in Level of TSH in the Blood | Baseline to 24 weeks | |
| Secondary | Mean Change in Level of Luteinizing Hormone in the Blood | Baseline to 24 weeks | |
| Secondary | Mean Change in Level of FSH in the Blood | Baseline to 24 weeks | |
| Secondary | Mean Change in Total Lean Body Mass | Baseline to 24 weeks |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced an AE | 36 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Change in Level of Free Testosterone in the Blood | Baseline to 24 weeks | pg/mL | MEAN | |
| SECONDARY | Mean Change in Level of Total Testosterone in the Blood | Baseline to 24 weeks | ng/dL | MEAN | |
| SECONDARY | Mean Change in Level of IGF-1 in the Blood | Baseline to 24 weeks | ng/mL | MEAN | |
| SECONDARY | Mean Change in Level of TSH in the Blood | Baseline to 24 weeks | uIU/mL | MEAN | |
| SECONDARY | Mean Change in Level of Luteinizing Hormone in the Blood | Baseline to 24 weeks | mIU/mL | MEAN | |
| SECONDARY | Mean Change in Level of FSH in the Blood | Baseline to 24 weeks | mIU/mL | MEAN | |
| SECONDARY | Mean Change in Total Lean Body Mass | Baseline to 24 weeks | Kg | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced an AE | Combination Therapy | 14 | Participants | ||
| Mean Change in Level of Free Testosterone in the Blood | Combination Therapy | 17.42 | Standard Deviation 77.94 | pg/mL | |
| Mean Change in Level of Total Testosterone in the Blood | Combination Therapy | 8.26 | Standard Deviation 277.94 | ng/dL | |
| Mean Change in Level of IGF-1 in the Blood | Combination Therapy | 89.79 | Standard Deviation 71.57 | ng/mL | |
| Mean Change in Level of TSH in the Blood | Combination Therapy | 0.37 | Standard Deviation 0.66 | uIU/mL | |
| Mean Change in Level of Luteinizing Hormone in the Blood | Combination Therapy | -3.48 | Standard Deviation 2.64 | mIU/mL | |
| Mean Change in Level of FSH in the Blood | Combination Therapy | -3.29 | Standard Deviation 4.47 | mIU/mL | |
| Mean Change in Total Lean Body Mass | Combination Therapy | 2.21 | Standard Deviation 1.79 | Kg |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Combination Therapy | 20 | |
| Overall Study | COMPLETED | Combination Therapy | 19 | |
| Overall Study | NOT COMPLETED | Combination Therapy | 1 |
Source ClinicalTrials.gov
Adverse events33
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Decreased energy | General disorders | Combination Therapy | 1 | 20 | |
| other | Exercise fatigue | General disorders | Combination Therapy | 1 | 20 | |
| other | Soreness | General disorders | Combination Therapy | 2 | 20 | |
| other | Increased appetite | General disorders | Combination Therapy | 2 | 20 | |
| other | Itchiness | General disorders | Combination Therapy | 1 | 20 | |
| other | Poison ivy | Skin and subcutaneous tissue disorders | Combination Therapy | 1 | 20 | |
| other | Vivid dreams | Psychiatric disorders | Combination Therapy | 1 | 20 | |
| other | Elevated IGF-1 | Blood and lymphatic system disorders | Combination Therapy | 3 | 20 | |
| other | Elevated testosterone | Blood and lymphatic system disorders | Combination Therapy | 1 | 20 | |
| other | Elevated HbA1c | Blood and lymphatic system disorders | Combination Therapy | 1 | 20 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combination Therapy | 0 | 20 |
| Total, other adverse events | Combination Therapy | 20 | 20 |
| Total, serious adverse events | Combination Therapy | 0 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40900971 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01NS095813 | STARFiSH: Study of Testosterone and rHGH in FSHD: A Proof-of-Concept Study | HEATWOLE, CHAD RYDEL | UNIVERSITY OF ROCHESTER | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2017 to 2020 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03123913
GET https://conductscience.org/api/trials/v1/NCT03123913/events?page=2