HypogonadismPhase 1NCT03345797
Evaluation of Testosterone Nasal Gel in Hypogonadal Boys
A Phase 1 study testing Testosterone Nasal Gel [Natesto] in people with Hypogonadism, run by Acerus Biopharma Inc. at 3 sites in United Kingdom.
Trial summary
PK study to evaluate serum levels of testosterone post nasal delivery in two cohorts of hypogonadal boys. Read more about this study
- Who is it for?
- Ages 12 to 17 years, men only
- Conditions the study is for
- Hypogonadism
- What is being tested?
- Testosterone Nasal Gel [Natesto]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 1 Mar 2018to 11 Apr 2022
- 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 12 to 17 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- ARM 1 (naïve patients): Participants who meet all of the following inclusion criteria will be eligible for participation in the study:
- Hypogonadal boys;
- Chronological age 12 to <18 years;
- No prior exposure to TRT;
- Prepubertal
- Parent/guardian and patient able to understand and provide signed informed consent;
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- ARM 2 (non-naïve patients): Participants who meet all of the following inclusion criteria will be eligible for participation in the study:
- Hypogonadal boys with a bone age of ≥13 years (a historical value within the last 12 months will be acceptable);
- Chronological age 12 to <18 years;
- Taking an existing TRT treatment dose;
- Tanner Stage ≥3
- Parent/guardian and patient able to understand and provide signed informed consent;
Who cannot join
- ARM 1 (naïve patients) AND ARM 2 (non-naïve patients): Participants who meet any of the following criteria will be excluded from participation in the study:
- Any active allergic condition or presentation of symptoms including allergic rhinitis;
- An upper respiratory tract infection;
- Use of any form of intranasal medication delivery other than periodic short-term (less than 3 days) use of sympathomimetic decongestants, within the last 3 months;
- In the opinion of the Investigator, significant intercurrent disease of any type, in particular liver, kidney, heart disease, stroke, or psychiatric illness;
- History of pituitary or hypothalamic tumors or history of any malignancy excluding basal cell or squamous cell carcinoma of the skin curatively treated by surgery;
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- History of nasal disorders, nasal or sinus surgery, nasal fracture within the previous 6 months or nasal fracture that caused a deviated anterior nasal septum surgery, mucosal inflammatory disorders, specifically Sjogren's syndrome;
- History of severe adverse drug reactions to testosterone therapies;
- Current treatment with other androgens (e.g., dehydroepiandrosterone [DHEA]), anabolic steroids, or other sex hormones;
- Treatment with estrogens, gonadotropin-releasing hormone (GnRH) agonists, or growth hormone within the previous 12 months;
- Treatment with drugs that interfere with the metabolism of testosterone, such as anastrozole, clomiphene, dutasteride, finasteride, flutamide, ketoconazole, spironolactone, or testolactone;
- Diabetes mellitus;
- Participation in any other research study during the conduct of this study or 30 days prior to the initiation of this study.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Cambridge University Hospital's NHS Foundation Trust
Cambridge, CB2 0QQ
University of Glasgow, Royal Hospital for Children
Glasgow, Scotland, G51 4TF
Alder Hey Children's Hospital
Liverpool, L14 5AB
About this study
Official title: A Multicenter, Open Label, Variable Dose, Two Arm Pilot Paediatric Phase 1 PK Study to Evaluate Testosterone Nasal Gel (4.5% w/w) in Hypogonadal Boys
PK study to evaluate serum levels of testosterone post nasal delivery in two cohorts of hypogonadal boys.
Read the detailed description
ARM 1 - 10 prepubertal, 12-17 years old boys with no prior exposure to TRT will receive single dose of 5.5 mg on day one and single dose of 11 mg on day 2 with repeat blood draws to assess serum levels of testosterone and metabolites.
ARM 2 - 10 Tanner Stage 3, 12-17 years old boys on TRT with bone age >= 13 years will receive single dose of 11 mg on day one, and single dose of 11 mg in the morning and a second 11 mg dose in the afternoon on day 2 with repeat blood draws to assess serum levels of testosterone and metabolites.
- Conditions
- Hypogonadism
- Being tested
- Testosterone Nasal Gel [Natesto]
- Keywords
- Paediatric
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone Nasal Gel [Natesto]Drug
nasal gel containing 4.5% w/w testosterone
| Study group | Role | What they receive |
|---|---|---|
| Naive patients - ARM 1 | Experimental | TRT naïve subjects, Tanner Stage of 0, receiving Testosterone Nasal Gel [Natesto] - Single dose of 5.5 mg Natesto on Day 1 and a single dose of 11 mg Natesto on Day 2 Receives: Drug: Testosterone Nasal Gel [Natesto] |
| Non-naive patients - ARM 2 | Experimental | TRT non-naïve subjects (have had prior testosterone treatment), Tanner Stage >/= 3, receiving Testosterone Nasal Gel [Natesto] - Single dose of 11 mg Natesto on Day 1. On Day 2, 11 mg dose of Natesto in the morning and 11 mg dose of Natesto 12 hours later Receives: Drug: Testosterone Nasal Gel [Natesto] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Cmax for serum testosterone, serum DHT and serum estradiol
Measured: 48 hours (approx)
Area under the curve (AUC)
AUC for serum testosterone, serum DHT and serum estradiol
Measured: 48 hours (approx)
Minimum serum concentration (Cmin)
Cmin for serum testosterone, serum DHT and serum estradiol
Measured: 48 hours (approx)
Time to reach maximum plasma concentration (tmax)
tmax for serum testosterone, serum DHT and serum estradiol
Measured: 48 hours (approx)
Secondary outcomes (2)
Incidence of Treatment-Emergent Adverse Events (Safety)
Safety assessments will include adverse events, clinical laboratory measurements of serum testosterone, DHT and estradiol levels, and vital sign measurements. A phone call will be made 3 days after the patient leaves the clinic to collect any SAEs or AEs that may occur.
Measured: 5 days
Incidence of Treatment-Emergent Adverse Events (Tolerability)
To include a adverse events that relate to tolerability and a patient and healthcare provider questionnaire on ease of use dispenser and gel administration
Measured: 48 hours (approx)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Mar 2018
- Primary completion11 Apr 2020
- Study completion11 Apr 2022
Why it stopped: Lack of patients and commercial reasons
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- dual arm: naïve vs TRT experienced
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acerus Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Syed Faisal Ahmed, MD, Principal investigator, Royal Hospital for Children, U. of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345797
- Sponsor's protocol ID
- NAT-2017-01
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2017
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Variable Dose, Two Arm Pilot Paediatric Phase 1 PK Study to Evaluate Testosterone Nasal Gel (4.5% w/w) in Hypogonadal Boys
- ClinicalTrials.gov ID
- NCT03345797
- Acronym / sponsor ID
- NAT-2017-01
- Conditions
- Hypogonadism
- Keywords
- Paediatric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patients and commercial reasons
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Acerus Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 11 Apr 2020 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 17 Nov 2017 (actual)
- 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.
PK study to evaluate serum levels of testosterone post nasal delivery in two cohorts of hypogonadal boys.
Detailed description
ARM 1 - 10 prepubertal, 12-17 years old boys with no prior exposure to TRT will receive single dose of 5.5 mg on day one and single dose of 11 mg on day 2 with repeat blood draws to assess serum levels of testosterone and metabolites.
ARM 2 - 10 Tanner Stage 3, 12-17 years old boys on TRT with bone age >= 13 years will receive single dose of 11 mg on day one, and single dose of 11 mg in the morning and a second 11 mg dose in the afternoon on day 2 with repeat blood draws to assess serum levels of testosterone and metabolites.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- dual arm: naïve vs TRT experienced
| Arm | Type | Receives |
|---|---|---|
| Naive patients - ARM 1 | Experimental | Drug: Testosterone Nasal Gel [Natesto]TRT naïve subjects, Tanner Stage of 0, receiving Testosterone Nasal Gel [Natesto] - Single dose of 5.5 mg Natesto on Day 1 and a single dose of 11 mg Natesto on Day 2 |
| Non-naive patients - ARM 2 | Experimental | Drug: Testosterone Nasal Gel [Natesto]TRT non-naïve subjects (have had prior testosterone treatment), Tanner Stage >/= 3, receiving Testosterone Nasal Gel [Natesto] - Single dose of 11 mg Natesto on Day 1. On Day 2, 11 mg dose of Natesto in the morning and 11 mg dose of Natesto 12 hours later |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- ARM 1 (naïve patients): Participants who meet all of the following inclusion criteria will be eligible for participation in the study:
- Hypogonadal boys;
- Chronological age 12 to <18 years;
- No prior exposure to TRT;
- Prepubertal
Key exclusion criteria (13 listed)
- ARM 1 (naïve patients) AND ARM 2 (non-naïve patients): Participants who meet any of the following criteria will be excluded from participation in the study:
- Any active allergic condition or presentation of symptoms including allergic rhinitis;
- An upper respiratory tract infection;
- Use of any form of intranasal medication delivery other than periodic short-term (less than 3 days) use of sympathomimetic decongestants, within the last 3 months;
- In the opinion of the Investigator, significant intercurrent disease of any type, in particular liver, kidney, heart disease, stroke, or psychiatric illness;
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 |
|---|---|---|
| Testosterone Nasal Gel [Natesto]nasal gel containing 4.5% w/w testosterone | Drug | Naive patients - ARM 1, Non-naive patients - ARM 2 |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: 48 hours (approx)
Cmax for serum testosterone, serum DHT and serum estradiol
Area under the curve (AUC)
Time frame: 48 hours (approx)
AUC for serum testosterone, serum DHT and serum estradiol
Minimum serum concentration (Cmin)
Time frame: 48 hours (approx)
Cmin for serum testosterone, serum DHT and serum estradiol
Time to reach maximum plasma concentration (tmax)
Time frame: 48 hours (approx)
tmax for serum testosterone, serum DHT and serum estradiol
2 secondary outcomes
Incidence of Treatment-Emergent Adverse Events (Safety)
Time frame: 5 days
Incidence of Treatment-Emergent Adverse Events (Tolerability)
Time frame: 48 hours (approx)
Results and safety
The study was stopped early (reason given: Lack of patients and commercial reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Syed Faisal Ahmed, MD principal investigator
Royal Hospital for Children, U. of Glasgow
3 sites 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 Nasal Gel [Natesto] in people with Hypogonadism, run by Acerus Biopharma Inc. at 3 sites in United Kingdom.
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 12 inclusion and 13 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: stopped early, as of the sponsor's last update on 26 Oct 2023. 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 Kingdom. 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 stopped early (reason given: Lack of patients and commercial reasons). Results are not available in the source record.
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?
Maximum plasma concentration (Cmax) (time frame: 48 hours (approx)). The study lists 4 primary outcomes in all. 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 26 Oct 2023.