HypogonadismPhase 1NCT00705796
Influence of Administration Route of Testosterone on Male Fertility
A Phase 1 study testing MPP10, testosterone and Testosterone in people with Hypogonadism, run by Acerus Pharmaceuticals Corporation at 1 site in Netherlands.
Trial summary
Exogenously administered testosterone will override the normal negative feedback of endogenous testosterone on the hypothalamus and pituitary. Constantly, relatively high and constant testosterone levels will cause a drop in FSH and LH production by the pituitary. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism
- What is being tested?
- MPP10, testosterone and Testosterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Start not givento not given
- 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 50 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 50 years but not older than 80 years of age;
- Serum testosterone level <13.8 nmol/l;
- Sperm concentration > 40 Million/ml;
- Willing to give written informed consent.
Who cannot join
- Testicular diseases or having had any surgical procedures applied to the testes;
- History or currently existing serious disease of any type, in particular liver, kidney or heart disease, any form of diabetes mellitus, cancer or psychiatric illness;
- Current androgen, anabolic steroid or sex hormone treatment or any treatment with such compounds in the previous 6 months;
- Blood donation within the 12-week period before the initial study dose.
- 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;
- Elevated serum PSA levels (> 4 ng/ml for subjects >= 50 years of age);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence on Human Male Fertility of Testosterone After Intranasal (MPP10) or Transdermal (AndroGel™) Application
Exogenously administered testosterone will override the normal negative feedback of endogenous testosterone on the hypothalamus and pituitary. Constantly, relatively high and constant testosterone levels will cause a drop in FSH and LH production by the pituitary. Since FSH and LH are signalling hormones to the testes, endogenous testosterone production and spermatogenesis will be down-regulated. It is expected that intranasal dosing in the morning will mimic the normal physiological pattern of testosterone production thereby avoiding negative side-effects on spermatogenesis. Trans-dermal gels give testosterone levels more or less constant over the day and will very likely have inhibitory effects on spermatogenesis.
The main objective of this study is to show that twice daily intranasal dosing does not have, or has a smaller inhibitory effect on spermatogenesis in comparison to transdermal testosterone gels.
- Conditions
- Hypogonadism
- Being tested
- MPP10, testosterone, Testosterone
- Keywords
- Hypogonadism, Spermatogenesis, Quality of Life
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPP10, testosteroneDrug
Also called Nasobol
Testosterone intranasal, 7.6 mg, twice daily to be taken immediately after waking up and washing/showering (approx. 7:00-8:00 AM) and at lunch time (approx. 12:00 AM).
TestosteroneDrug
Also called AndroGel
AndroGel® 50 mg, once daily in the morning after washing/showering.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 will be treated with MPP10, 7.6 mg, twice daily to be taken immediately after waking up and washing/showering (approx. 7:00-8:00 AM) and at lunch time (approx. 12:00 AM). Receives: Drug: MPP10, testosterone |
| Group 2 | Active comparator | Group 2 will be treated with AndroGel® 50 mg, once daily in the morning after washing/showering. Receives: Drug: Testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main study parameter is the change in sperm concentration during the 4-month study period for each of the two treatment groups.
Measured: 4 months
Secondary outcomes (2)
The effects of treatment on the health related quality of life (QoL);
Measured: 4 months
The influence of transdermal and intranasal testosterone treatment on morphology and motility on sperm cells and on the volume of the ejaculate;
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
Why it stopped: financial constraints
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acerus Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Margarita Budumian, MD, Principal investigator, AMPHA, Toernooiveld 220, 6525 EC Nijmegen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705796
- Sponsor's protocol ID
- Nasobol 02/2008
- Status last verified
- Mar 2018
- First submitted
- 25 Jun 2008
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence on Human Male Fertility of Testosterone After Intranasal (MPP10) or Transdermal (AndroGel™) Application
- ClinicalTrials.gov ID
- NCT00705796
- Acronym / sponsor ID
- Nasobol 02/2008
- Conditions
- Hypogonadism
- Keywords
- Hypogonadism, Spermatogenesis, Quality of Life
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: financial constraints
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Acerus Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- First posted
- 26 Jun 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.
Exogenously administered testosterone will override the normal negative feedback of endogenous testosterone on the hypothalamus and pituitary. Constantly, relatively high and constant testosterone levels will cause a drop in FSH and LH production by the pituitary. Since FSH and LH are signalling hormones to the testes, endogenous testosterone production and spermatogenesis will be down-regulated. It is expected that intranasal dosing in the morning will mimic the normal physiological pattern of testosterone production thereby avoiding negative side-effects on spermatogenesis. Trans-dermal gels give testosterone levels more or less constant over the day and will very likely have inhibitory effects on spermatogenesis.
The main objective of this study is to show that twice daily intranasal dosing does not have, or has a smaller inhibitory effect on spermatogenesis in comparison to transdermal testosterone gels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: MPP10, testosteroneGroup 1 will be treated with MPP10, 7.6 mg, twice daily to be taken immediately after waking up and washing/showering (approx. 7:00-8:00 AM) and at lunch time (approx. 12:00 AM). |
| Group 2 | Active comparator | Drug: TestosteroneGroup 2 will be treated with AndroGel® 50 mg, once daily in the morning after washing/showering. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than or equal to 50 years but not older than 80 years of age;
- Serum testosterone level <13.8 nmol/l;
- Sperm concentration > 40 Million/ml;
- Willing to give written informed consent.
Key exclusion criteria (6 listed)
- Testicular diseases or having had any surgical procedures applied to the testes;
- History or currently existing serious disease of any type, in particular liver, kidney or heart disease, any form of diabetes mellitus, cancer or psychiatric illness;
- Current androgen, anabolic steroid or sex hormone treatment or any treatment with such compounds in the previous 6 months;
- Blood donation within the 12-week period before the initial study dose.
- 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;
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 |
|---|---|---|
| MPP10, testosteroneAlso: NasobolTestosterone intranasal, 7.6 mg, twice daily to be taken immediately after waking up and washing/showering (approx. 7:00-8:00 AM) and at lunch time (approx. 12:00 AM). | Drug | Group 1 |
| TestosteroneAlso: AndroGelAndroGel® 50 mg, once daily in the morning after washing/showering. | Drug | Group 2 |
Primary outcome
The main study parameter is the change in sperm concentration during the 4-month study period for each of the two treatment groups.
Time frame: 4 months
2 secondary outcomes
The effects of treatment on the health related quality of life (QoL);
Time frame: 4 months
The influence of transdermal and intranasal testosterone treatment on morphology and motility on sperm cells and on the volume of the ejaculate;
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
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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.
Margarita Budumian, MD principal investigator
AMPHA, Toernooiveld 220, 6525 EC Nijmegen, The Netherlands
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 MPP10, testosterone and Testosterone in people with Hypogonadism, run by Acerus Pharmaceuticals Corporation at 1 site in Netherlands.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 13 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 Netherlands. 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 was withdrawn before enrolling participants, so there are no results.
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?
The main study parameter is the change in sperm concentration during the 4-month study period for each of the two treatment groups. (time frame: 4 months). 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 13 Mar 2018.