Trial Outcomes & Findings for Study of Testosterone and rHGH in FSHD (NCT NCT03123913)
NCT ID: NCT03123913
Last Updated: 2023-05-16
Results Overview
AEs were collected through patient report, interval laboratory studies, resting echocardiograms, dual energy x-ray absorptiometry (DEXA) studies, and physical examinations.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
36 weeks
Results posted on
2023-05-16
Participant Flow
Participant milestones
| Measure |
Combination Therapy
Testosterone Enanthate and Somatropin
Testosterone Enanthate: Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.
Somatropin: Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Testosterone and rHGH in FSHD
Baseline characteristics by cohort
| Measure |
Combination Therapy
n=20 Participants
Testosterone Enanthate and Somatropin
Testosterone Enanthate: Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.
Somatropin: Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.
|
|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 weeksAEs were collected through patient report, interval laboratory studies, resting echocardiograms, dual energy x-ray absorptiometry (DEXA) studies, and physical examinations.
Outcome measures
| Measure |
Combination Therapy
n=20 Participants
Testosterone Enanthate and Somatropin
Testosterone Enanthate: Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.
Somatropin: Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.
|
|---|---|
|
Number of Participants Who Experienced an AE
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksOutcome measures
| Measure |
Combination Therapy
n=19 Participants
Testosterone Enanthate and Somatropin
Testosterone Enanthate: Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.
Somatropin: Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.
|
|---|---|
|
Mean Change in Level of Free Testosterone in the Blood
|
17.42 pg/mL
Standard Deviation 77.94
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksOutcome measures
| Measure |
Combination Therapy
n=19 Participants
Testosterone Enanthate and Somatropin
Testosterone Enanthate: Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.
Somatropin: Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.
|
|---|---|
|
Mean Change in Level of Total Testosterone in the Blood
|
8.26 ng/dL
Standard Deviation 277.94
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksOutcome measures
| Measure |
Combination Therapy
n=19 Participants
Testosterone Enanthate and Somatropin
Testosterone Enanthate: Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.
Somatropin: Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.
|
|---|---|
|
Mean Change in Level of IGF-1 in the Blood
|
89.79 ng/mL
Standard Deviation 71.57
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksOutcome measures
| Measure |
Combination Therapy
n=19 Participants
Testosterone Enanthate and Somatropin
Testosterone Enanthate: Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.
Somatropin: Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.
|
|---|---|
|
Mean Change in Level of TSH in the Blood
|
0.37 uIU/mL
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksOutcome measures
| Measure |
Combination Therapy
n=19 Participants
Testosterone Enanthate and Somatropin
Testosterone Enanthate: Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.
Somatropin: Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.
|
|---|---|
|
Mean Change in Level of Luteinizing Hormone in the Blood
|
-3.48 mIU/mL
Standard Deviation 2.64
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksOutcome measures
| Measure |
Combination Therapy
n=19 Participants
Testosterone Enanthate and Somatropin
Testosterone Enanthate: Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.
Somatropin: Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.
|
|---|---|
|
Mean Change in Level of FSH in the Blood
|
-3.29 mIU/mL
Standard Deviation 4.47
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksOutcome measures
| Measure |
Combination Therapy
n=19 Participants
Testosterone Enanthate and Somatropin
Testosterone Enanthate: Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.
Somatropin: Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.
|
|---|---|
|
Mean Change in Total Lean Body Mass
|
2.21 Kg
Standard Deviation 1.79
|
Adverse Events
Combination Therapy
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Combination Therapy
n=20 participants at risk
Testosterone Enanthate and Somatropin
Testosterone Enanthate: Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.
Somatropin: Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.
|
|---|---|
|
General disorders
Decreased energy
|
5.0%
1/20 • 36 weeks
|
|
General disorders
Exercise fatigue
|
5.0%
1/20 • 36 weeks
|
|
General disorders
Soreness
|
10.0%
2/20 • 36 weeks
|
|
General disorders
Increased appetite
|
10.0%
2/20 • 36 weeks
|
|
General disorders
Itchiness
|
5.0%
1/20 • 36 weeks
|
|
Skin and subcutaneous tissue disorders
Poison ivy
|
5.0%
1/20 • 36 weeks
|
|
Psychiatric disorders
Vivid dreams
|
5.0%
1/20 • 36 weeks
|
|
Blood and lymphatic system disorders
Elevated IGF-1
|
15.0%
3/20 • 36 weeks
|
|
Blood and lymphatic system disorders
Elevated testosterone
|
5.0%
1/20 • 36 weeks
|
|
Blood and lymphatic system disorders
Elevated HbA1c
|
5.0%
1/20 • 36 weeks
|
|
Blood and lymphatic system disorders
Elevated insulin
|
5.0%
1/20 • 36 weeks
|
|
Blood and lymphatic system disorders
Elevated HCT
|
5.0%
1/20 • 36 weeks
|
|
Blood and lymphatic system disorders
Elevated glucose
|
5.0%
1/20 • 36 weeks
|
|
Renal and urinary disorders
Glycosuria
|
5.0%
1/20 • 36 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • 36 weeks
|
|
Nervous system disorders
Parathesia
|
5.0%
1/20 • 36 weeks
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • 36 weeks
|
|
General disorders
Edema limbs
|
10.0%
2/20 • 36 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • 36 weeks
|
|
General disorders
Fatigue
|
5.0%
1/20 • 36 weeks
|
|
General disorders
Flu-like symptoms
|
10.0%
2/20 • 36 weeks
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • 36 weeks
|
|
General disorders
Injection site reaction
|
35.0%
7/20 • 36 weeks
|
|
Psychiatric disorders
Irritability
|
5.0%
1/20 • 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
10.0%
2/20 • 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
1/20 • 36 weeks
|
|
General disorders
Pain
|
10.0%
2/20 • 36 weeks
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.0%
1/20 • 36 weeks
|
|
Renal and urinary disorders
Urine discoloration
|
5.0%
1/20 • 36 weeks
|
|
Investigations
Weight gain
|
5.0%
1/20 • 36 weeks
|
|
General disorders
White patches on tongue
|
5.0%
1/20 • 36 weeks
|
Additional Information
Chad Heatwole, MD, MS-CI
University of Rochester Medical Center
Phone: 585-275-7867
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place