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Efficacy and Tolerability of an Intra-Nasal Testosterone Product

Efficacy and Tolerability of Nasobol®, an Intra-Nasal Testosterone Product, for Testosterone Replacement in Hypogonadal Men

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00975650
Enrollment
57
Registered
2009-09-11
Start date
2009-08-31
Completion date
2010-05-31
Last updated
2018-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism

Keywords

Primary Hypogonadism, Secondary Hypogonadism

Brief summary

This clinical trial is being performed to compare the pharmacokinetic profile of testosterone after repeated intra-nasal administration of products of different strengths in subjects with hypogonadism.

Detailed description

Primary Objective: The primary objective of this study was to determine the efficacy of Nasobol in the treatment of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by establishing a pharmacokinetic profile for serum testosterone levels following Nasobol treatment, and comparing it to that of the active control, Androderm®. Secondary Objective: To establish a safety profile for Nasobol.

Interventions

DRUGNasobol®

Intra-nasal Testosterone (2 syringes), b.i.d.

DRUGAndroderm® (Positive Control)

QD administration

Sponsors

Acerus Pharmaceuticals Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
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

MeasureTime frameDescription
Serum Testosterone Ln-Cmax0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.The primary objective of this study was to determine the efficacy of Nasobol in the treatment of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by establishing a pharmacokinetic profile for serum testosterone levels following Nasobol treatment or that of the active control, Androderm®.
Serum Testosterone Ln-AUCt0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.—
Serum Testosterone Cavg0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.—
Serum Dihydrotestosterone Ln-Cmax0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.—
Serum Dihydrotestosterone Ln-AUCt0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.—
Serum Dihydrotestosterone Cavg0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.—
Percentage of Subjects With Cavg Within the Reference RangeEach period is 7 daysThe percentage of subjects with a Cavg within the reference range of 300 to 1050 ng/dL and 25.5 to 97.8 ng/dL for testosterone and dihydotestosterone.

Countries

United States

Participant flow

Participants by arm

ArmCount
All Subjects
All Subjects who were dosed.
57
Total57

Baseline characteristics

CharacteristicAll Subjects
Age, Continuous52.0 years
STANDARD_DEVIATION 12
Ethnicity (NIH/OMB)
Hispanic or Latino
19 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
38 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
4 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
53 Participants
Region of Enrollment
United States
57 Participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
57 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 570 / 560 / 540 / 55
other
Total, other adverse events
5 / 576 / 560 / 546 / 55
serious
Total, serious adverse events
0 / 570 / 560 / 540 / 55

Outcome results

Primary

Percentage of Subjects With Cavg Within the Reference Range

The percentage of subjects with a Cavg within the reference range of 300 to 1050 ng/dL and 25.5 to 97.8 ng/dL for testosterone and dihydotestosterone.

Time frame: Each period is 7 days

Population: Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Treatment APercentage of Subjects With Cavg Within the Reference RangeTestosterone19 Participants
Treatment APercentage of Subjects With Cavg Within the Reference RangeDihydrotestosterone24 Participants
Treatment BPercentage of Subjects With Cavg Within the Reference RangeDihydrotestosterone31 Participants
Treatment BPercentage of Subjects With Cavg Within the Reference RangeTestosterone27 Participants
Treatment CPercentage of Subjects With Cavg Within the Reference RangeTestosterone27 Participants
Treatment CPercentage of Subjects With Cavg Within the Reference RangeDihydrotestosterone34 Participants
Treatment DPercentage of Subjects With Cavg Within the Reference RangeTestosterone42 Participants
Treatment DPercentage of Subjects With Cavg Within the Reference RangeDihydrotestosterone22 Participants
Primary

Serum Dihydrotestosterone Cavg

Time frame: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.

Population: Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.

ArmMeasureValue (MEAN)Dispersion
Treatment ASerum Dihydrotestosterone Cavg25.24 ng/dLStandard Deviation 8.51
Treatment BSerum Dihydrotestosterone Cavg28.97 ng/dLStandard Deviation 11.41
Treatment CSerum Dihydrotestosterone Cavg30.79 ng/dLStandard Deviation 12.5
Treatment DSerum Dihydrotestosterone Cavg24.69 ng/dLStandard Deviation 8.46
Primary

Serum Dihydrotestosterone Ln-AUCt

Time frame: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.

Population: Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.

ArmMeasureValue (MEAN)Dispersion
Treatment ASerum Dihydrotestosterone Ln-AUCt6.34 ng.h/dLStandard Deviation 0.38
Treatment BSerum Dihydrotestosterone Ln-AUCt6.47 ng.h/dLStandard Deviation 0.41
Treatment CSerum Dihydrotestosterone Ln-AUCt6.52 ng.h/dLStandard Deviation 0.45
Treatment DSerum Dihydrotestosterone Ln-AUCt6.33 ng.h/dLStandard Deviation 0.34
Primary

Serum Dihydrotestosterone Ln-Cmax

Time frame: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.

Population: Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.

ArmMeasureValue (MEAN)Dispersion
Treatment ASerum Dihydrotestosterone Ln-Cmax3.54 ng/dLStandard Deviation 0.38
Treatment BSerum Dihydrotestosterone Ln-Cmax3.67 ng/dLStandard Deviation 0.44
Treatment CSerum Dihydrotestosterone Ln-Cmax3.80 ng/dLStandard Deviation 0.41
Treatment DSerum Dihydrotestosterone Ln-Cmax3.44 ng/dLStandard Deviation 0.35
Primary

Serum Testosterone Cavg

Time frame: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.

Population: Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.

ArmMeasureValue (MEAN)Dispersion
Treatment ASerum Testosterone Cavg287.10 ng/dLStandard Deviation 76.42
Treatment BSerum Testosterone Cavg316.64 ng/dLStandard Deviation 88.93
Treatment CSerum Testosterone Cavg336.11 ng/dLStandard Deviation 100.76
Treatment DSerum Testosterone Cavg384.62 ng/dLStandard Deviation 102.97
Primary

Serum Testosterone Ln-AUCt

Time frame: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.

Population: Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.

ArmMeasureValue (MEAN)Dispersion
Treatment ASerum Testosterone Ln-AUCt8.80 ng.h/dLStandard Deviation 0.26
Treatment BSerum Testosterone Ln-AUCt8.90 ng.h/dLStandard Deviation 0.27
Treatment CSerum Testosterone Ln-AUCt8.95 ng.h/dLStandard Deviation 0.29
Treatment DSerum Testosterone Ln-AUCt9.09 ng.h/dLStandard Deviation 0.29
Primary

Serum Testosterone Ln-Cmax

The primary objective of this study was to determine the efficacy of Nasobol in the treatment of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by establishing a pharmacokinetic profile for serum testosterone levels following Nasobol treatment or that of the active control, Androderm®.

Time frame: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.

Population: Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.

ArmMeasureValue (MEAN)Dispersion
Treatment ASerum Testosterone Ln-Cmax6.25 ng/dLStandard Deviation 0.37
Treatment BSerum Testosterone Ln-Cmax6.41 ng/dLStandard Deviation 0.35
Treatment CSerum Testosterone Ln-Cmax6.54 ng/dLStandard Deviation 0.36
Treatment DSerum Testosterone Ln-Cmax6.36 ng/dLStandard Deviation 0.37

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026