HypogonadismPhase 2NCT00975650

Efficacy and Tolerability of an Intra-Nasal Testosterone Product

A Phase 2 study testing Nasobol® in people with Hypogonadism, run by Acerus Pharmaceuticals Corporation at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years, men only
Conditions the study is for: Hypogonadism
What is being tested?: Nasobol®
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 6 sitesUnited States
Study dates: Aug 2009to May 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Providence Clinical Research
Burbank, California, 91505
Cetero Research
Miami Gardens, Florida, 33169
dgd Research Inc.
San Antonio, Texas, 78229
Regional Urology, LLC
Shreveport, Louisiana, 71106
Quality of Life Medical & Research centre
Tucson, Arizona, 85712
Clinical Research Institute
Wichita, Kansas, 67221

Other trials in United States

About this study

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

Read the 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.

Conditions: Hypogonadism
Being tested: Nasobol®, Androderm® (Positive Control)
Keywords: Primary Hypogonadism, Secondary Hypogonadism
Medical subject headings: Hypogonadism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nasobol®Drug
Intra-nasal Testosterone (2 syringes), b.i.d.
Androderm® (Positive Control)Drug
QD administration

Study groups in NCT00975650
Study group	Role	What they receive
Test 8.0, Ref 5.0, Test 14.0, Test 11.0	Experimental	Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Receives: Drug: Nasobol®; Drug: Androderm® (Positive Control)
Test 11.0, Test 8.0, Ref 5.0, Test 14.0	Experimental	Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days Receives: Drug: Nasobol®; Drug: Androderm® (Positive Control)
Test 14.0, Test 11.0, Test 8.0, Ref 5.0	Experimental	Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Receives: Drug: Nasobol®; Drug: Androderm® (Positive Control)
Ref 5.0, Test 14.0, Test 11.0, Test 8.0	Experimental	Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days Receives: Drug: Nasobol®; Drug: Androderm® (Positive Control)

What is being measured

The primary outcome is the main question the study is designed to answer.

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®.
Measured: 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.
Serum Testosterone Ln-AUCt
Measured: 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.
Serum Testosterone Cavg
Measured: 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.
Serum Dihydrotestosterone Ln-Cmax
Measured: 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.
Serum Dihydrotestosterone Ln-AUCt
Measured: 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.
Serum Dihydrotestosterone Cavg
Measured: 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.
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.
Measured: Each period is 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009May 2010

First posted11 Sep 2009 (estimated)
Study startAug 2009
Primary completionMay 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypogonadismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00975650
Sponsor's protocol ID: Nasobol-01-2009
Other IDs: TBS1-01
Status last verified: Aug 2018
First submitted: 10 Sep 2009
Last updated: 13 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Hypogonadism, Male
RecruitingPhase 4
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Prostate Cancer, Hypogonadism, Male
RecruitingObservational study
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All Hypogonadism trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Tolerability of Nasobol®, an Intra-Nasal Testosterone Product, for Testosterone Replacement in Hypogonadal Men
ClinicalTrials.gov ID: NCT00975650
Acronym / sponsor ID: Nasobol-01-2009
Conditions: Hypogonadism
Keywords: Primary Hypogonadism, Secondary Hypogonadism
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Acerus Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 11 Sep 2009 (estimated)
Results: Posted 13 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary Objective:

Secondary Objective:

To establish a safety profile for Nasobol.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Test 8.0, Ref 5.0, Test 14.0, Test 11.0	Experimental	Drug: Nasobol®, Drug: Androderm® (Positive Control)Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days;
Test 11.0, Test 8.0, Ref 5.0, Test 14.0	Experimental	Drug: Nasobol®, Drug: Androderm® (Positive Control)Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
Test 14.0, Test 11.0, Test 8.0, Ref 5.0	Experimental	Drug: Nasobol®, Drug: Androderm® (Positive Control)Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days;
Ref 5.0, Test 14.0, Test 11.0, Test 8.0	Experimental	Drug: Nasobol®, Drug: Androderm® (Positive Control)Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days

Who may qualify

Ages: 18 to 80 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nasobol®Intra-nasal Testosterone (2 syringes), b.i.d.	Drug	Ref 5.0, Test 14.0, Test 11.0, Test 8.0, Test 11.0, Test 8.0, Ref 5.0, Test 14.0, Test 14.0, Test 11.0, Test 8.0, Ref 5.0, Test 8.0, Ref 5.0, Test 14.0, Test 11.0
Androderm® (Positive Control)QD administration	Drug	Ref 5.0, Test 14.0, Test 11.0, Test 8.0, Test 11.0, Test 8.0, Ref 5.0, Test 14.0, Test 14.0, Test 11.0, Test 8.0, Ref 5.0, Test 8.0, Ref 5.0, Test 14.0, Test 11.0

Primary outcome

Serum Testosterone 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.
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-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.
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.
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.
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.
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.
Percentage of Subjects With Cavg Within the Reference Range
Time frame: Each period is 7 days
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.

Results and safety

Results posted to the registry on 13 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1	13	13
Sequence 2	16	16
Sequence 3	14	14
Sequence 4	14	14

Primary outcome: Serum Testosterone 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.. Mean (Standard Deviation). Unit: ng/dL

Measure	Treatment A n = 52	Treatment B n = 55	Treatment C n = 52	Treatment D n = 54
Value	6.25 (0.37)	6.41 (0.35)	6.54 (0.36)	6.36 (0.37)

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

Primary outcome: 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.. Mean (Standard Deviation). Unit: ng.h/dL

Measure	Treatment A n = 52	Treatment B n = 55	Treatment C n = 52	Treatment D n = 54
Value	8.80 (0.26)	8.90 (0.27)	8.95 (0.29)	9.09 (0.29)

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

Primary outcome: 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.. Mean (Standard Deviation). Unit: ng/dL

Measure	Treatment A n = 52	Treatment B n = 55	Treatment C n = 52	Treatment D n = 54
Value	287.10 (76.42)	316.64 (88.93)	336.11 (100.76)	384.62 (102.97)

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

Primary outcome: 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.. Mean (Standard Deviation). Unit: ng/dL

Measure	Treatment A n = 52	Treatment B n = 55	Treatment C n = 52	Treatment D n = 54
Value	3.54 (0.38)	3.67 (0.44)	3.80 (0.41)	3.44 (0.35)

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

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 57 (0%)	5 of 57 (8.8%)	0 of 57
Treatment B	0 of 56 (0%)	6 of 56 (10.7%)	0 of 56
Treatment C	0 of 54 (0%)	0 of 54 (0%)	0 of 54
Treatment D	0 of 55 (0%)	6 of 55 (10.9%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul Desjardins, Ph.D study director

Trimel Biopharma

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nasobol® in people with Hypogonadism, run by Acerus Pharmaceuticals Corporation at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Testosterone 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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00975650.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.