Study of Testosterone and rHGH in FSHD (STARFISH)
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|ClinicalTrials.gov Identifier: NCT03123913|
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Facioscapulohumeral Muscular Dystrophy||Drug: Testosterone Enanthate Drug: Somatropin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Testosterone and rHGH in FSHD (STARFISH): A Proof-of-Concept Study|
|Actual Study Start Date :||December 18, 2017|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Combination therapy
Testosterone Enanthate and Somatropin
Drug: Testosterone Enanthate
Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.
Other Names:Drug: Somatropin
Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 36 weeks ]Safety and tolerability are monitored by interval laboratory studies, resting echocardiograms, dual energy x-ray absorptiometry (DEXA) studies, and physical examinations. Patients will report any adverse events through in-person and telephone evaluations as well as on patient diaries.
- Serum levels of free and total testosterone, IGF-1, thyroid function, luteinizing hormone and follicle stimulating hormone [ Time Frame: 36 weeks ]Serum levels of free and total testosterone, IGF-1, thyroid function, luteinizing hormone and follicle stimulating hormone will be assessed at each study visit.
- Lean body mass [ Time Frame: 36 weeks ]Lean body mass will be measured at study visits through dual energy x-ray absorptiometry (DEXA) studies.
- Ambulation [ Time Frame: 36 weeks ]Ambulation will be assessed as an exploratory measure with the Six Minute Walk Test.
- Strength [ Time Frame: 36 weeks ]Strength will be assessed as an exploratory measure with manual muscle testing and quantitative muscle testing.
- Pulmonary Function [ Time Frame: 36 weeks ]Pulmonary function will be assessed as an exploratory measures with forced vital capacity testing.
- Patient-Reported Disease Burden [ Time Frame: 36 weeks ]Patient-reported disease burden will be assessed as an exploratory measure with the FSHD-Health Index, PROMIS-57, Beck Depression Inventory, Epworth Sleepiness Scale, Fatigue Severity Scale, and International Prostate Symptoms Score.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123913
|Contact: Elizabeth A Luebbe, MSfirstname.lastname@example.org|
|United States, New York|
|University of Rochester||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Chad Heatwole, MD|
|Principal Investigator:||Chad R Heatwole, MD, MS-CI||University of Rochester|