HypogonadismPhase 2NCT01252745

Efficacy of an Intranasal Testosterone Product

A Phase 2 study testing 10.0 mg of Testosterone, 4.0% TID, 13.5 mg of Testosterone, 4.5% B.I.D and 11.25 mg of Testosterone, 4.5% T.I.D in people with Hypogonadism, run by Acerus Pharmaceuticals Corporation at 3 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 will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 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?: 10.0 mg of Testosterone, 4.0% TID, 13.5 mg of Testosterone, 4.5% B.I.D and 11.25 mg of Testosterone, 4.5% T.I.D
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 3 sitesUnited States
Study dates: Aug 2010to Dec 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

3 sites in 1 country.

United States3 sites

Pharmax Research Clinic Inc.
Miami, Florida
Regional Urology LLC
Shreveport, Louisiana
Quality of Life Medical and Research Center
Tucson, Arizona

Other trials in United States

About this study

Official title: An Open Label, Randomized, Balanced, Three Treatment, Parallel Design, Pharmacokinetic Study of Intranasal TBS-1 Administration to Hypogonadal Men

This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism

Conditions: Hypogonadism
Being tested: 10.0 mg of Testosterone, 4.0% TID, 13.5 mg of Testosterone, 4.5% B.I.D, 11.25 mg of Testosterone, 4.5% T.I.D
Medical subject headings: Hypogonadism

What participants receive

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

10.0 mg of Testosterone, 4.0% TIDDrug
Also called 10.0 mg of TBS-1, 4.0% TID
13.5 mg of Testosterone, 4.5% B.I.DDrug
Also called 13.5 mg of TBS-1, 4.5% B.I.D
11.25 mg of Testosterone, 4.5% T.I.DDrug
Also called 11.25 mg of TBS-1, 4.5% T.I.D

Study groups in NCT01252745
Study group	Role	What they receive
10.0 mg of TBS-1, 4.0% T.I.D.	Experimental	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) Receives: Drug: 10.0 mg of Testosterone, 4.0% TID
13.5 mg of TBS-1, 4.5% B.I.D	Experimental	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) Receives: Drug: 13.5 mg of Testosterone, 4.5% B.I.D
11.25 mg of TBS-1, 4.5% T.I.D	Experimental	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) Receives: Drug: 11.25 mg of Testosterone, 4.5% T.I.D

What is being measured

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

Cmax of Serum Testosterone
Measured: 24 hours
Cavg of Serum Testosterone
Measured: 24 hours
AUC0-t of Serum Testosterone
Measured: 24 hours

Timeline

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

Aug 2010Dec 2010

First posted3 Dec 2010 (estimated)
Study startAug 2010
Primary completionNov 2010
Study completionDec 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: Parallel groups
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01252745
Sponsor's protocol ID: TBS-1-2010-01
Status last verified: Apr 2018
First submitted: 1 Dec 2010
Last updated: 23 May 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

RecruitingObservational study
Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism
Hypogonadism, Male, Endocrine Disease
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
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
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship

All Hypogonadism trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Randomized, Balanced, Three Treatment, Parallel Design, Pharmacokinetic Study of Intranasal TBS-1 Administration to Hypogonadal Men
ClinicalTrials.gov ID: NCT01252745
Acronym / sponsor ID: TBS-1-2010-01
Conditions: Hypogonadism
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Acerus Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Nov 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 3 Dec 2010 (estimated)
Results: Posted 26 Apr 2018

Clinical summary

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

This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
10.0 mg of TBS-1, 4.0% T.I.D.	Experimental	Drug: 10.0 mg of Testosterone, 4.0% TIDTBS-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)
13.5 mg of TBS-1, 4.5% B.I.D	Experimental	Drug: 13.5 mg of Testosterone, 4.5% B.I.DTBS-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)
11.25 mg of TBS-1, 4.5% T.I.D	Experimental	Drug: 11.25 mg of Testosterone, 4.5% T.I.DTBS-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)

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
10.0 mg of Testosterone, 4.0% TIDAlso: 10.0 mg of TBS-1, 4.0% TID	Drug	10.0 mg of TBS-1, 4.0% T.I.D.
13.5 mg of Testosterone, 4.5% B.I.DAlso: 13.5 mg of TBS-1, 4.5% B.I.D	Drug	13.5 mg of TBS-1, 4.5% B.I.D
11.25 mg of Testosterone, 4.5% T.I.DAlso: 11.25 mg of TBS-1, 4.5% T.I.D	Drug	11.25 mg of TBS-1, 4.5% T.I.D

Primary outcome

Cmax of Serum Testosterone
Time frame: 24 hours
Cavg of Serum Testosterone
Time frame: 24 hours
AUC0-t of Serum Testosterone
Time frame: 24 hours

Results and safety

Results posted to the registry on 26 Apr 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
10.0 mg Testosterone t.i.d.	8	8
13.5 mg Testosterone b.i.d.	7	7
11.25 mg Testosterone t.i.d.	7	7

Primary outcome: Cmax of Serum Testosterone

Time frame: 24 hours. Mean (Standard Deviation). Unit: ng/dL

Measure	10.0 mg Testosterone t.i.d. n = 8	13.5 mg Testosterone b.i.d. n = 7	11.25 mg Testosterone t.i.d. n = 7
Value	830 (188)	1050 (463)	883 (346)

Primary outcome: Cavg of Serum Testosterone

Time frame: 24 hours. Mean (Standard Deviation). Unit: ng/dL

Measure	10.0 mg of TBS-1, 4.0% T.I.D. n = 8	13.5 mg of TBS-1, 4.5% B.I.D n = 7	11.25 mg of TBS-1, 4.5% T.I.D n = 7
Value	413 (138)	408 (147)	396 (110)

Primary outcome: AUC0-t of Serum Testosterone

Time frame: 24 hours. Mean (Standard Deviation). Unit: ng.h/dL

Measure	10.0 mg Testosterone t.i.d. n = 8	13.5 mg Testosterone b.i.d. n = 7	11.25 mg Testosterone t.i.d. n = 7
Value	9920.07 (3300.65)	9781.39 (3532.43)	9505.03 (2650.59)

Adverse events

Time frame: 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
10.0 mg Testosterone t.i.d.	0 of 8 (0%)	4 of 8 (50%)	0 of 8
13.5 mg Testosterone b.i.d.	0 of 7 (0%)	2 of 7 (28.6%)	0 of 7
11.25 mg Testosterone t.i.d.	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypogonadism

RecruitingObservational study
Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism
Hypogonadism, Male, Endocrine Disease
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
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
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RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

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 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 26 Apr 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?

Cmax of Serum Testosterone (time frame: 24 hours). The study lists 3 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 NCT01252745.

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 23 May 2018.