Male HypogonadismPhase 3NCT01446042
Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism
A Phase 3 study testing Testosterone in people with Male Hypogonadism, run by Acerus Pharmaceuticals Corporation at 30 sites in United States.
Trial summary
The purpose of this study is to determine the efficacy (based on the pharmacokinetic profile of testosterone) and safety of TBS-1 in the treatment of hypogonadal men Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Male Hypogonadism
- What is being tested?
- Testosterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 30 sitesUnited States
- Study dates
- Sep 2011to Mar 2013
- Phase
- Phase 3
- 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
- Male between 18 and 80 years of age
- Able to understand and provide signed informed consent
- Have 2 fasting morning (0900 h ± 30 min) serum total testosterone levels <300 ng/dL
- Body mass index between 18.5 kg/m2 and 35 kg/m2
- Hemoglobin level > or = 13.0 g/dL
- Screening laboratory assessments within ±15% of the normal range, with the exception of liver function tests (which need to be within the normal range) and HbA1c (which must be <7.0% [9.5 mmol/L]); lipid profile and endocrine profile assessments are also exempt from this range unless the assessments indicate a significant intercurrent illness other than testosterone deficiency
- Ear, nose and throat examination including nasal endoscopy without clinically significant abnormal findings
- Normal prostate for age based on digital rectal exam and a serum PSA <4.0 ng/mL.
Who cannot join
- Significant intercurrent disease of any type, in particular liver, kidney, heart disease, or psychiatric illness
- Hyperparathyroidism, uncontrolled diabetes mellitus, hypothyroidism, or hyperthyroidism (thyroid stimulating hormone should be <1.5 times the upper limit of normal)
- Hematocrit >54% at screening
- History of pituitary or hypothalamic tumors or history of malignancy within the past 5 years, excluding basal cell or squamous cell carcinoma of the skin curatively treated by surgery
- History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, "nose job," or sinus surgery
- History of nasal fractures within the past 6 months and/or prior nasal fractures that caused a severely deviated anterior nasal septum
Show all 28Show fewer
- Active allergies, such as rhinitis, rhinorrhea, and nasal congestion
- Mucosal inflammatory disorders, specifically pemphigus or Sjogren's syndrome
- Sinus disease, specifically acute sinusitis, chronic sinusitis, or allergic fungal sinusitis
- History of nasal disorders (eg, polyposis, recurrent epistaxis [>1 nose bleed per month], abuse of nasal decongestants) or sleep apnea
- Use of any form of intranasal medication delivery, specifically nasal corticosteroids and oxymetazoline-containing nasal sprays (eg, Dristan® 12-Hour Nasal Spray)
- History of severe adverse drug reaction or leukopenia
- A known hypersensitivity to lidocaine or any materials that may be used during the study
- History of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation
- History of hepatitis B, a positive test for hepatitis B surface antigen, a history of hepatitis C, or a positive test for hepatitis C antibody
- Presence of human immunodeficiency virus infection or antibodies
- History of asthma and ongoing asthma treatment
- History of sleeping problems or a shift worker
- Smoker of >10 cigarettes (or equivalent) per day
- Regular consumption of more than 4 units of alcohol daily (1 unit is defined as 300 mL of beer, 1 glass of wine, or 1 measure of spirit) or difficulty abstaining from alcohol during the 48 hours prior to the 24 hour blood sampling visits
- History or current evidence of abuse of alcohol or any drug substance, licit or illicit, or positive urine drug and alcohol screen
- Treatment with androgen therapy within at least 2 weeks prior to baseline evaluations (subjects on androgen therapy will require a washout period of 4 weeks for depot products administered intramuscularly [eg, testosterone enanthate 200 mg/mL] and 2 weeks for products administered orally or topically [oral, patch, gel, or buccal])
- Current treatment with other androgens (eg, dehydroepiandrosterone [DHEA]), anabolic steroids, or other sex hormones
- Treatment with estrogens, gonadotropin-releasing hormone (GnRH) agonists, or growth hormone within previous 12 months
- Treatment with drugs that interfere with the metabolism of testosterone, such as anastrozole, clomiphene, dutasteride, finasteride, flutamide, ketoconazole, spironolactone, or testolactone
- Treatment with any antihypertensive, antidepressant, tranquilizer, or histamine 2 (H2) receptor blocker that is not part of a stable regimen (stable dose for at least 3 months prior to baseline);
- Poor compliance history or low likelihood of maintaining attendance
- Participation in any other research study during the conduct of this study or 30 days prior to the initiation of this study or blood donation at any time during this study and within the 12 week period prior to screening
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Austin Center for Clinical Research
Austin, Texas, 78756
Alabama Clinical Therapeutics LLC
Birmingham, Alabama, 35235
Innovative Research of West Florida
Clearwater, Florida, 33756
Clinical Research of South Florida
Coral Gables, Florida, 33134
Reseach Across America
Dallas, Texas, 75234
SC Clinical Research Inc
Garden Grove, California, 92844
Centex Research
Houston, Texas, 77062
Clinical Trial Network
Houston, Texas, 77074
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801
The Clinical Trial Center
Jenkintown, Pennsylvania, 19046
Center for Pharmaceutical Research
Kansas City, Missouri, 61114
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104
Central Kentucky Research Associates
Lexington, Kentucky, 40509
Commonwealth Biomedical Research LLC
Madisonville, Kentucky, 42431
Pharmax Research Clinic
Miami, Florida, 33126
Coastal Clinical Research
Mobile, Alabama, 36608
Coastal Carolina Research Center Inc
Mt. Pleasant, South Carolina, 29464
National Clinical Research - Norfolk
Norfolk, Virginia, 23502
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Capital Clinical Reseach Center
Olympia, Washington, 98502
Compass Research East LLC
Oviedo, Florida, 32765
Rainier Clinical Research Center
Renton, Washington, 98057
National Clinical Research
Richmond, Virginia, 23294
Rochester Clinical Research
Rochester, New York, 14609
Cetero Research
San Antonio, Texas, 78229
Regional Urology LLC
Shreveport, Louisiana, 71106
Quality of Life Medical Research Center
Tucson, Arizona, 85712
Diablo Clinical Reseach Inc.
Walnut Creek, California, 94598
Omega Medical Research
Warwick, Rhode Island, 02886
Granger Medical Clinic
West Valley City, Utah, 84120
About this study
Official title: A 90-Day, Randomized, Dose-Ranging Study, Including Potential Dose Titration, Evaluating the Efficacy and Safety of Intranasal TBS-1 in the Treatment of Male Hypogonadism With Sequential Safety Extension Periods of 90 and 180 Days
The purpose of this study is to determine the efficacy (based on the pharmacokinetic profile of testosterone) and safety of TBS-1 in the treatment of hypogonadal men
Read the detailed description
This study is a 4 Period study consists of 16 visits with overnight clinic stays that span over year to help determine the efficacy of TBS-1 gel administered twice daily (b.i.d) and three times daily (t.i.d)
In addition, this study will investigate the safety and tolerability of TBS-1 after 90, 180 and 360 days of treatment.
- Conditions
- Male Hypogonadism
- Being tested
- Testosterone
- Medical subject headings
- Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Intranasal testosterone
TestosteroneDrug
Intranasal testosterone
| Study group | Role | What they receive |
|---|---|---|
| TBS-1 - b.i.d. | Experimental | 5.5 mg per nostril of 4.5% TBS-1 BID Receives: Drug: Testosterone |
| TBS-1 - t.i.d. | Experimental | 5.5 mg per nostril of 4.5% TBS-1 TID Receives: Drug: Testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Testosterone Cavg
The percentage of patients with an average serum total testosterone concentration (Cavg) within the normal range (300 to 1050 ng/dL)
Measured: 90 days
Secondary outcomes (1)
Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90
To determine the efficacy of 4.5% TBS-1 gel, administered 2 or 3 times daily at a dose of 5.5 mg per nostril, in achieving the following serum total testosterone maximum concentration (Cmax) on Day 90:
- A Cmax (maximum testosterone concentration) value of 1500 ng/dL or more in at least 85% of the participants analyzed
- A Cmax (maximum testosterone concentration) value of 1800 to 2500 ng/dL in fewer than 5% of participants analyzed
- No analyzed participants with a Cmax (maximum testosterone concentration) >2500 ng/dL
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2012
- Study completionMar 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Male 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acerus Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalia Tkachenko, MD, Study director, Trimel Pharmaceuticals Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446042
- Sponsor's protocol ID
- TBS-1-2011-03
- Status last verified
- Mar 2018
- First submitted
- 30 Sep 2011
- Last updated
- 13 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rogol AD, Tkachenko N, Bryson N. Natesto , a novel testosterone nasal gel, normalizes androgen levels in hypogonadal men. Andrology. 2016 Jan;4(1):46-54. doi: 10.1111/andr.12137. Epub 2015 Dec 22.
PubMed 26695758
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 90-Day, Randomized, Dose-Ranging Study, Including Potential Dose Titration, Evaluating the Efficacy and Safety of Intranasal TBS-1 in the Treatment of Male Hypogonadism With Sequential Safety Extension Periods of 90 and 180 Days
- ClinicalTrials.gov ID
- NCT01446042
- Acronym / sponsor ID
- TBS-1-2011-03
- Conditions
- Male Hypogonadism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Acerus Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Oct 2011 (estimated)
- Results
- Posted 13 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy (based on the pharmacokinetic profile of testosterone) and safety of TBS-1 in the treatment of hypogonadal men
Detailed description
This study is a 4 Period study consists of 16 visits with overnight clinic stays that span over year to help determine the efficacy of TBS-1 gel administered twice daily (b.i.d) and three times daily (t.i.d)
In addition, this study will investigate the safety and tolerability of TBS-1 after 90, 180 and 360 days of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBS-1 - b.i.d. | Experimental | Drug: Testosterone5.5 mg per nostril of 4.5% TBS-1 BID |
| TBS-1 - t.i.d. | Experimental | Drug: Testosterone5.5 mg per nostril of 4.5% TBS-1 TID |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male between 18 and 80 years of age
- Able to understand and provide signed informed consent
- Have 2 fasting morning (0900 h ± 30 min) serum total testosterone levels <300 ng/dL
- Body mass index between 18.5 kg/m2 and 35 kg/m2
- Hemoglobin level > or = 13.0 g/dL
Key exclusion criteria (28 listed)
- Significant intercurrent disease of any type, in particular liver, kidney, heart disease, or psychiatric illness
- Hyperparathyroidism, uncontrolled diabetes mellitus, hypothyroidism, or hyperthyroidism (thyroid stimulating hormone should be <1.5 times the upper limit of normal)
- Hematocrit >54% at screening
- History of pituitary or hypothalamic tumors or history of malignancy within the past 5 years, excluding basal cell or squamous cell carcinoma of the skin curatively treated by surgery
- History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, "nose job," or sinus surgery
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 |
|---|---|---|
| TestosteroneIntranasal testosterone | Drug | TBS-1 - b.i.d. |
| TestosteroneIntranasal testosterone | Drug | TBS-1 - t.i.d. |
Primary outcome
Serum Testosterone Cavg
Time frame: 90 days
The percentage of patients with an average serum total testosterone concentration (Cavg) within the normal range (300 to 1050 ng/dL)
1 secondary outcome
Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26695758Rogol AD, Tkachenko N, Bryson N. Natesto , a novel testosterone nasal gel, normalizes androgen levels in hypogonadal men. Andrology. 2016 Jan;4(1):46-54. doi: 10.1111/andr.12137. Epub 2015 Dec 22.
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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.
Natalia Tkachenko, MD study director
Trimel Pharmaceuticals Corporation
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Testosterone in people with Male Hypogonadism, run by Acerus Pharmaceuticals Corporation at 30 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 8 inclusion and 28 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 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jun 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 Cavg (time frame: 90 days). 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 NCT01446042, which also lists 1 linked publication.
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 Jun 2018.