HypogonadismPhase 1NCT00647868
NASOBOL in Hypogonadal Men in Comparison to Testosterone Levels in Normal Healthy Male Volunteers
A Phase 1 study testing testosterone in people with Hypogonadism, run by Acerus Pharmaceuticals Corporation at 1 site in United States.
Trial summary
In this study the serum concentration of testosterone and its main metabolite DHT will be measured in hypogonadal men using intranasal testosterone (Nasobol). Different treatment regimens (once and twice daily) and administration times will be tested. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism
- What is being tested?
- testosterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Mar 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 20 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- men with primary or secondary hypogonadism and testosterone serum levels below 300 ng/dl [= 10.4 nmol/l], on two occasions within a period of one month before inclusion;
- age: 20-60 years;
- normal thyroid function, physiologic prolactin concentration;
- normal otorhinolaryngologic examination (ENT examination);
- normal 24-h activity-rest pattern;
- written Informed Consent.
Show all 11Show fewer
- men with testosterone serum levels above 300 ng/dl [= 10.4 nmol/l] on two occasions within a period of one month before inclusion;
- age: 20-60 years;
- normal thyroid function, physiologic prolactin concentration;
- normal 24-h activity-rest pattern;
- written Informed Consent.
Who cannot join
- significant intercurrent disease of any type, in particular liver, kidney or heart disease, any form of diabetes mellitus or psychiatric illness (patients with treated hyperlipidemia, arterial hypertension or treated hyper- or hypothyroidism will not be excluded provided they have been stable on their medication for at least two months);
- history of, or current nasal disorders (e.g. seasonal or perennial allergic rhinitis, atrophic rhinitis, polyposis, abuse of nasal decongestants, clinically relevant nasal septum deviation, recurrent epistaxis) or sleep apnea;
- sleeping disorders;
- abnormal prostate examination indicative for prostate cancer or elevated serum PSA levels (PSA < 2.5 ng/ml for subjects < 40 years of age and < 4 ng/ml for subjects >= 40 years of age);
- history of cancer, especially breast, prostate or testicular tumor; excluding skin cancer;
- history of severe or multiple allergies, severe adverse drug reaction or leucopenia. A known hypersensitivity to lignocaine/lidocaine or all surgical dressings which may be used in the study procedures;
Show all 30Show fewer
- history of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture or intravenous cannulation, or a history of Hepatitis B, a positive test for Hepatitis B surface antigen, a history of Hepatitis C, a positive test for Hepatitis C antibody, a history of HIV infection or demonstration of HIV antibodies;
- the patient is a heavy smoker currently smoking > 20 cigarettes per day or smoking history >10 pack years (1 pack year is defined as 20 cigarettes per day for 1 year);
- regular drinkers of more than four (4) units of alcohol daily (1 unit = 300 ml of beer, 1 glass of wine, 1 measure of spirit) or those who may have difficulty in abstaining from alcohol during the 48 hours prior to the initial-dose administration and for the duration of the study;
- history or current evidence of abuse of alcohol or any drug substance, licit or illicit; or positive urine drug and alcohol screen for drugs of abuse and alcohol;
- treatment with other androgens (e.g. DHEA), anabolic steroids or other sex hormones within one month prior to Day 1 of the study;
- testosterone treatment in the previous 2 weeks (oral, buccal, topical, nasal) or 4 weeks (intramuscular);
- current or recent (previous 4 weeks) use of over the counter male enhancement products;
- use of nasal decongestants and nasal corticosteroids;
- shift work;
- transmeridian flights within 1 month before Day 1 of the study;
- poor compliers or those unlikely to attend;
- intake of any drug as part of a research study within 30 days of initial-dose administration in this study and throughout the study;
- blood donation within the 12-week period before the initial study dose.
- significant intercurrent disease of any type, in particular liver, kidney or heart disease, any form of diabetes mellitus or psychiatric illness (patients with treated hyperlipidemia, arterial hypertension or treated hyper- or hypothyroidism will not be excluded provided they have been stable on their medication for at least two months);
- history of hypogonadism;
- sleeping disorders;
- treatment with other androgens (e.g. DHEA), anabolic steroids or other sex hormones within one month prior to Day 1 of the study;
- testosterone treatment in the previous 2 weeks (oral, buccal, topical, nasal) or 4 weeks (intramuscular);
- current or recent (previous 4 weeks) use of over the counter male enhancement products;
- shift work;
- transmeridian flights within 1 month before Day 1 of the study;
- the patient is a heavy smoker currently smoking > 20 cigarettes per day or smoking history >10 pack years (1 pack year is defined as 20 cigarettes per day for 1 year);
- regular drinkers of more than four (4) units of alcohol daily (1 unit = 300 ml of beer, 1 glass of wine, 1 measure of spirit) or those who may have difficulty in abstaining from alcohol during the 48 hours prior to the 24-h blood sampling day;
- blood donation within the 12-week period before the 24-h blood sampling day.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harbor - UCLA Medical Center
Torrance, California, 90509
About this study
Official title: A Multiple Dose, Pharmacokinetic Study Comparing Different Regimens of Testosterone Given as Intranasal NASOBOL® in Hypogonadal Men in Comparison to Testosterone Levels in Normal Healthy Male Volunteers
In this study the serum concentration of testosterone and its main metabolite DHT will be measured in hypogonadal men using intranasal testosterone (Nasobol). Different treatment regimens (once and twice daily) and administration times will be tested. The serum levels obtained will be compared with those of healthy men.
It is expected that intranasal administration of Nasobol will restore testosterone and DHT levels to nearly normal.
Read the detailed description
This pharmacokinetic trial is performed with the aim to determine the pharmacokinetic behavior of testosterone after repeated nasal administration of NASOBOL® in patients with hypogonadism and to compare the levels of the major analytes to levels seen in normal healthy men. For this purpose, four different treatment schedules of administration of NASOBOL® will be tested and compared to 24-h levels in normal healthy men.
This is a Phase I, pharmacokinetic trial with different administration schemes of NASOBOL® in patients with moderate hypogonadism (Groups 1, 2 and 3). For reference purposes frequent blood samples will be taken in a group of healthy men (Group 4). Subjects will be screened for eligibility not more than 4 weeks before the 1st dose of NASOBOL®. Total study duration for hypogonadal patients is maximally 38 days (including a 3 days placebo run-in phase). Healthy men will be screened for eligibility and will be in the clinic for only 1 day (with overnight stay) during the study.
For hypogonadal patients 7 visits to the clinic are planned, amongst which 2 visits for 24-h PK sampling each with an overnight stay. Seven days after the last dose of NASOBOL® hypogonadal patients will be asked to come to the clinic for a final follow-up visit.
Telephone follow-ups will be done on Days 7, 13, 21 and 27 to check whether subjects have taken their medication.
- Conditions
- Hypogonadism
- Being tested
- testosterone
- Keywords
- pharmacokinetics, testosterone, hypogonadism
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testosteroneDrug
Also called Nasobol
Intranasal testosterone, 7.6 mg (3.8 mg in each nostril) per application
| Study group | Role | What they receive |
|---|---|---|
| Groups 1 and 2 | Experimental | Twice daily (7:00 am and 12:00 am or 7:00 am and 10:00 pm) dosing with intranasal testosterone for 14 days Receives: Drug: testosterone |
| Groups 3a and b | Experimental | Single daily administration of testosterone (at 7:00 am or 10:00 pm) for 14 days Receives: Drug: testosterone |
| Group 4 | No intervention | 24-h blood sampling in healthy eugonadal controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testosterone serum concentration
Measured: 14 and 28 days after treatment
Secondary outcomes (1)
Difference of serum T levels in treated hypogonadal men vs. eugonadal men
Measured: After 14 and 28 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acerus Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christina Wang, MD, Principal investigator, General Clinical Research Center - Harbor UCLA Medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647868
- Sponsor's protocol ID
- Nasobol 01/2008
- Status last verified
- Mar 2018
- First submitted
- 27 Mar 2008
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose, Pharmacokinetic Study Comparing Different Regimens of Testosterone Given as Intranasal NASOBOL® in Hypogonadal Men in Comparison to Testosterone Levels in Normal Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00647868
- Acronym / sponsor ID
- Nasobol 01/2008
- Conditions
- Hypogonadism
- Keywords
- pharmacokinetics, testosterone, hypogonadism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Acerus Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the serum concentration of testosterone and its main metabolite DHT will be measured in hypogonadal men using intranasal testosterone (Nasobol). Different treatment regimens (once and twice daily) and administration times will be tested. The serum levels obtained will be compared with those of healthy men.
It is expected that intranasal administration of Nasobol will restore testosterone and DHT levels to nearly normal.
Detailed description
This pharmacokinetic trial is performed with the aim to determine the pharmacokinetic behavior of testosterone after repeated nasal administration of NASOBOL® in patients with hypogonadism and to compare the levels of the major analytes to levels seen in normal healthy men. For this purpose, four different treatment schedules of administration of NASOBOL® will be tested and compared to 24-h levels in normal healthy men.
This is a Phase I, pharmacokinetic trial with different administration schemes of NASOBOL® in patients with moderate hypogonadism (Groups 1, 2 and 3). For reference purposes frequent blood samples will be taken in a group of healthy men (Group 4). Subjects will be screened for eligibility not more than 4 weeks before the 1st dose of NASOBOL®. Total study duration for hypogonadal patients is maximally 38 days (including a 3 days placebo run-in phase). Healthy men will be screened for eligibility and will be in the clinic for only 1 day (with overnight stay) during the study.
For hypogonadal patients 7 visits to the clinic are planned, amongst which 2 visits for 24-h PK sampling each with an overnight stay. Seven days after the last dose of NASOBOL® hypogonadal patients will be asked to come to the clinic for a final follow-up visit.
Telephone follow-ups will be done on Days 7, 13, 21 and 27 to check whether subjects have taken their medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Groups 1 and 2 | Experimental | Drug: testosteroneTwice daily (7:00 am and 12:00 am or 7:00 am and 10:00 pm) dosing with intranasal testosterone for 14 days |
| Groups 3a and b | Experimental | Drug: testosteroneSingle daily administration of testosterone (at 7:00 am or 10:00 pm) for 14 days |
| Group 4 | No intervention | –24-h blood sampling in healthy eugonadal controls |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- men with primary or secondary hypogonadism and testosterone serum levels below 300 ng/dl [= 10.4 nmol/l], on two occasions within a period of one month before inclusion;
- age: 20-60 years;
- normal thyroid function, physiologic prolactin concentration;
- normal otorhinolaryngologic examination (ENT examination);
- normal 24-h activity-rest pattern;
Key exclusion criteria (30 listed)
- significant intercurrent disease of any type, in particular liver, kidney or heart disease, any form of diabetes mellitus or psychiatric illness (patients with treated hyperlipidemia, arterial hypertension or treated hyper- or hypothyroidism will not be excluded provided they have been stable on their medication for at least two months);
- history of, or current nasal disorders (e.g. seasonal or perennial allergic rhinitis, atrophic rhinitis, polyposis, abuse of nasal decongestants, clinically relevant nasal septum deviation, recurrent epistaxis) or sleep apnea;
- sleeping disorders;
- abnormal prostate examination indicative for prostate cancer or elevated serum PSA levels (PSA < 2.5 ng/ml for subjects < 40 years of age and < 4 ng/ml for subjects >= 40 years of age);
- history of cancer, especially breast, prostate or testicular tumor; excluding skin cancer;
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 |
|---|---|---|
| testosteroneAlso: NasobolIntranasal testosterone, 7.6 mg (3.8 mg in each nostril) per application | Drug | Groups 1 and 2, Groups 3a and b |
Primary outcome
Testosterone serum concentration
Time frame: 14 and 28 days after treatment
1 secondary outcome
Difference of serum T levels in treated hypogonadal men vs. eugonadal men
Time frame: After 14 and 28 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
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
Prostate Cancer, Hypogonadism, Male
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.
Christina Wang, MD principal investigator
General Clinical Research Center - Harbor UCLA Medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing testosterone in people with Hypogonadism, run by Acerus Pharmaceuticals Corporation at 1 site 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 11 inclusion and 30 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 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Testosterone serum concentration (time frame: 14 and 28 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2018.