New testosterone spray could offer quick fix for low t
NCT ID NCT01894308
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 2 trial tests a new testosterone spray (HypoSpray) in 48 men with low testosterone. Participants receive one of four doses daily for 7 days. The goal is to measure how testosterone levels change and check for skin reactions. Results will guide future, longer studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Testosterone
- What this could lead to
- If successful, this could lead to a more convenient testosterone replacement option for men with low testosterone.
- What could go wrong
- This is a small, early-phase study with only 48 participants and 7 days of treatment. It is designed to find the right dose, not to prove long-term safety or effectiveness. Skin reactions or ineffective dosing are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Hypogonadal Male subjects - morning testosterone level ≤300 ng/dL (10.4 ng/L). 2. 18 and 75 years of age, inclusive. 3. The subject is willing and able to read, understand the Subject Information Sheet and provide written informed consent. 4. The subject has a body mass index (BMI) within 18-30 kg/m2. 5. The subject is in otherwise good health as determined by medical history and physical examination. 6. The subject is a non-smoker. 7. The subject must agree to comply with the placement of an indwelling catheter on two separate occasions and the drawing of blood samples for the pharmacokinetic assessments. 8. The subject is willing and able to comply with all testing and requirements defined in the protocol. 9. The subject is willing and able to return to the study site for all visits. Exclusion Criteria: 1. The subject has any relevant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator, particularly an elevated PSA reading \>4.0 ng/ml or ALT and AST greater than 2 times the upper limit of normal, clinically significant anemia (hematocrit \<35%) or renal dysfunction (creatinine \>2mg/dL), active deep vein thrombosis, thromboembolic disorders or history of these conditions. 2. The subject has had a clinically significant illness within 30 days preceding entry into this study. 3. The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease. 4. The subject has a known allergy or history of hypersensitivity to Testosterone or similar compounds. 5. The subject has used any prescription medication within 14 days or over-the-counter (OTC) medication or alcohol within 48 hours of dosing or intends to use any prescription or OTC medication during the study that may interfere with the evaluation of study medication. 6. The subject has donated or lost a significant volume of blood (\>450 mL) within four (4) weeks of the study, and their haemoglobin concentration and haematocrit have not returned to within 5% of normal. 7. The subject has a Hematocrit level \> 51% 8. The subject has a history of substance abuse or a current positive urine drug screen or urine alcohol test. 9. Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males). 10. Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry. 11. Subjects with an American Urological Association System Index for Prostatism score greater than 7 12. Subjects with a history of prostate or breast carcinoma. 13. Subjects with prostatic mass on screening physical examination. 14. Subjects with a history of significant skin disease. 15. Subjects with a history of sleep apnea. 16. Subject with a partner with a history of breast cancer. 17. Subject with a partner of child bearing potential who is not willing to use adequate contraception for the duration of the trial. 18. Subject whose partner is pregnant.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Advanced Therapies Centre, The London Clinic
London, NW1 4LJ, United Kingdom
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