Hypogonadism
Conditions
Brief summary
This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism
Interventions
DRUG10.0 mg of Testosterone, 4.0% TID
DRUG13.5 mg of Testosterone, 4.5% B.I.D
DRUG11.25 mg of Testosterone, 4.5% T.I.D
Sponsors
Acerus Pharmaceuticals Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Men with primary or secondary hypogonadism and a serum morning (0900 h ± 30 minutes) testosterone levels \>100 ng/dl and ≤ 300 ng/dL. * Normal Otolaryngological nasal endoscopy examination. * Normal prostate examination (no palpable prostatic mass), and serum PSA ≤ 4.0 ng/mL.
Exclusion criteria
* Current treatment with other androgens (i.e. DHEA), anabolic steroids or other sex hormones * Treatment with Estrogens, GnRH antagonists, or Growth Hormone within previous 12 months * History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, or sinus surgery. * History of nasal disorders (e.g. polyposis, recurrent epistaxis ( \> 1 nose bleed per month, abuse of nasal decongestants) or sleep apnea.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cavg of Serum Testosterone | 24 hours |
| AUC0-t of Serum Testosterone | 24 hours |
| Cmax of Serum Testosterone | 24 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 10.0 mg Testosterone t.i.d. TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day) | 8 |
| 13.5 mg Testosterone b.i.d. TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day) | 7 |
| 11.25 mg Testosterone t.i.d. TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day) | 7 |
| Total | 22 |
Baseline characteristics
| Characteristic | 10.0 mg Testosterone t.i.d. | Total | 11.25 mg Testosterone t.i.d. | 13.5 mg Testosterone b.i.d. |
|---|---|---|---|---|
| Age, Continuous | 52.38 years STANDARD_DEVIATION 12.55 | 52.59 years STANDARD_DEVIATION 10.78 | 51.57 years STANDARD_DEVIATION 9.9 | 53.86 years STANDARD_DEVIATION 11.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 10 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 12 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 21 Participants | 6 Participants | 7 Participants |
| Region of Enrollment United States | 8 Participants | 22 Participants | 7 Participants | 7 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 22 Participants | 7 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 4 / 8 | 2 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 | 0 / 7 |
Outcome results
Primary
AUC0-t of Serum Testosterone
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10.0 mg Testosterone t.i.d. | AUC0-t of Serum Testosterone | 9920.07 ng.h/dL | Standard Deviation 3300.65 |
| 13.5 mg Testosterone b.i.d. | AUC0-t of Serum Testosterone | 9781.39 ng.h/dL | Standard Deviation 3532.43 |
| 11.25 mg Testosterone t.i.d. | AUC0-t of Serum Testosterone | 9505.03 ng.h/dL | Standard Deviation 2650.59 |
Primary
Cavg of Serum Testosterone
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10.0 mg Testosterone t.i.d. | Cavg of Serum Testosterone | 413 ng/dL | Standard Deviation 138 |
| 13.5 mg Testosterone b.i.d. | Cavg of Serum Testosterone | 408 ng/dL | Standard Deviation 147 |
| 11.25 mg Testosterone t.i.d. | Cavg of Serum Testosterone | 396 ng/dL | Standard Deviation 110 |
Primary
Cmax of Serum Testosterone
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10.0 mg Testosterone t.i.d. | Cmax of Serum Testosterone | 830 ng/dL | Standard Deviation 188 |
| 13.5 mg Testosterone b.i.d. | Cmax of Serum Testosterone | 1050 ng/dL | Standard Deviation 463 |
| 11.25 mg Testosterone t.i.d. | Cmax of Serum Testosterone | 883 ng/dL | Standard Deviation 346 |