HypogonadotropismPhase 2PARC-T-DNCT01894308
A Dose Ranging Study to Examine TDS-Testosterone 5%
A Phase 2 study testing Testosterone and Pump Sprayer in people with Hypogonadotropism, run by Transdermal Delivery Solutions Corp at 1 site in United Kingdom.
Trial summary
This study is a continuation of previous studies done in healthy volunteers to prove the efficacy of delivering Testosterone, the male hormone, rapidly across intact skin in s series of doses from low to high in men with low-to-no natural testosterone production to measure their response to the varying doses. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Hypogonadotropism
- What is being tested?
- Testosterone and Pump Sprayer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2027to Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypogonadal Male subjects - morning testosterone level ≤300 ng/dL (10.4 ng/L).
- 18 and 75 years of age, inclusive.
- The subject is willing and able to read, understand the Subject Information Sheet and provide written informed consent.
- The subject has a body mass index (BMI) within 18-30 kg/m2.
- The subject is in otherwise good health as determined by medical history and physical examination.
- The subject is a non-smoker.
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- 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.
- The subject is willing and able to comply with all testing and requirements defined in the protocol.
- The subject is willing and able to return to the study site for all visits.
Who cannot join
- 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.
- The subject has had a clinically significant illness within 30 days preceding entry into this study.
- The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
- The subject has a known allergy or history of hypersensitivity to Testosterone or similar compounds.
- 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.
- 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.
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- The subject has a Hematocrit level > 51%
- The subject has a history of substance abuse or a current positive urine drug screen or urine alcohol test.
- Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males).
- Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry.
- Subjects with an American Urological Association System Index for Prostatism score greater than 7
- Subjects with a history of prostate or breast carcinoma.
- Subjects with prostatic mass on screening physical examination.
- Subjects with a history of significant skin disease.
- Subjects with a history of sleep apnea.
- Subject with a partner with a history of breast cancer.
- Subject with a partner of child bearing potential who is not willing to use adequate contraception for the duration of the trial.
- Subject whose partner is pregnant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Advanced Therapies Centre, The London Clinic
London, NW1 4LJ
About this study
Official title: A Multiple-Dose, Single Period, Phase II Dose Ranging Study to Examine TDS-Testosterone 5% in Adult Male Subjects
This study is a continuation of previous studies done in healthy volunteers to prove the efficacy of delivering Testosterone, the male hormone, rapidly across intact skin in s series of doses from low to high in men with low-to-no natural testosterone production to measure their response to the varying doses. The results of this study will inform further studies which will be longer in length, as to the starting doses. The study will be conducted in London, U.K. at the Advanced Therapies Centre, The London Clinic.
Read the detailed description
48 Patients will be enrolled following 2 independent verifying blood tests of their diagnosis of Hypogonadism. there will be 4 cohorts of 12 subjects, each receiving doses of the trail materials, titrated by means of number of sprays applied. Doses will range from 10 to 70 mgs Testosterone.
- Conditions
- Hypogonadotropism
- Being tested
- Testosterone, Pump Sprayer
- Keywords
- Male Hormone Replacement, Multiple Dose, Single Period, Phase II, Dose Ranging, Adult Male Subjects, Testosterone Replacement
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
10,30,50 and 70 mg doses of micronized Testosterone delivered by means of a new liquid transdermal delivery solution, HypoSpray(R)once daily for 7 days or until halted due to systemic or dermal reactions.
Pump SprayerDevice
A dose of product solution is delivered by means of a metered pump spray.
| Study group | Role | What they receive |
|---|---|---|
| Forearm dose | Active comparator | Half of Ss will receive their dose of Testosterone on the inner aspects of their forearms. Receives: Drug: Testosterone; Device: Pump Sprayer |
| Chest Dose | Active comparator | Half of Ss will receive their dose of Testosterone on the chest. Receives: Drug: Testosterone; Device: Pump Sprayer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Range Measure of serum levels of testosterone in response to varying doses
A pharmacokinetic measure of serum levels of testosterone in response to varying doses of from 10 to 70 mgs of Testosterone.
Measured: 1 week
Secondary outcomes (1)
Dermal Safety as measured by
Incidence of treatment-emergent side effects.
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJun 2027 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypogonadotropismStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transdermal Delivery Solutions Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Advanced Therapies Centre, The London Clinic
- Responsible party
- Sponsor
- Investigators
- Shern L. Chew, M.D., Ph.D., Principal investigator, Consultant Physician and Professor of Endocrine Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894308
- Sponsor's protocol ID
- PARC-Testosterone-D1/09/13
- Other IDs
- 2013-001766-42, IRAS project ID: 146877
- Acronym
- PARC-T-D
- Status last verified
- Sep 2025
- First submitted
- 3 Jul 2013
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Chik Z, Johnston A, Tucker AT, Chew SL, Michaels L, Alam CA. Pharmacokinetics of a new testosterone transdermal delivery system, TDS-testosterone in healthy males. Br J Clin Pharmacol. 2006 Mar;61(3):275-9. doi: 10.1111/j.1365-2125.2005.02542.x.
PubMed 16487220
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Dose, Single Period, Phase II Dose Ranging Study to Examine TDS-Testosterone 5% in Adult Male Subjects
- ClinicalTrials.gov ID
- NCT01894308
- Acronym / sponsor ID
- PARC-T-D / PARC-Testosterone-D1/09/13
- Conditions
- Hypogonadotropism
- Keywords
- Male Hormone Replacement, Multiple Dose, Single Period, Phase II, Dose Ranging, Adult Male Subjects, Testosterone Replacement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Transdermal Delivery Solutions CorpIndustry (pharma, biotech, devices)
- Collaborators
- Advanced Therapies Centre, The London Clinic
- Study start
- Jun 2027 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 10 Jul 2013 (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.
This study is a continuation of previous studies done in healthy volunteers to prove the efficacy of delivering Testosterone, the male hormone, rapidly across intact skin in s series of doses from low to high in men with low-to-no natural testosterone production to measure their response to the varying doses. The results of this study will inform further studies which will be longer in length, as to the starting doses. The study will be conducted in London, U.K. at the Advanced Therapies Centre, The London Clinic.
Detailed description
48 Patients will be enrolled following 2 independent verifying blood tests of their diagnosis of Hypogonadism. there will be 4 cohorts of 12 subjects, each receiving doses of the trail materials, titrated by means of number of sprays applied. Doses will range from 10 to 70 mgs Testosterone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forearm dose | Active comparator | Drug: Testosterone, Device: Pump SprayerHalf of Ss will receive their dose of Testosterone on the inner aspects of their forearms. |
| Chest Dose | Active comparator | Drug: Testosterone, Device: Pump SprayerHalf of Ss will receive their dose of Testosterone on the chest. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Hypogonadal Male subjects - morning testosterone level ≤300 ng/dL (10.4 ng/L).
- 18 and 75 years of age, inclusive.
- The subject is willing and able to read, understand the Subject Information Sheet and provide written informed consent.
- The subject has a body mass index (BMI) within 18-30 kg/m2.
- The subject is in otherwise good health as determined by medical history and physical examination.
Key exclusion criteria (18 listed)
- 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.
- The subject has had a clinically significant illness within 30 days preceding entry into this study.
- The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
- The subject has a known allergy or history of hypersensitivity to Testosterone or similar compounds.
- 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.
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 |
|---|---|---|
| Testosterone10,30,50 and 70 mg doses of micronized Testosterone delivered by means of a new liquid transdermal delivery solution, HypoSpray(R)once daily for 7 days or until halted due to systemic or dermal reactions. | Drug | Chest Dose, Forearm dose |
| Pump SprayerA dose of product solution is delivered by means of a metered pump spray. | Device | Chest Dose, Forearm dose |
Primary outcome
Dose Range Measure of serum levels of testosterone in response to varying doses
Time frame: 1 week
A pharmacokinetic measure of serum levels of testosterone in response to varying doses of from 10 to 70 mgs of Testosterone.
1 secondary outcome
Dermal Safety as measured by
Time frame: 1 Week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 16487220Chik Z, Johnston A, Tucker AT, Chew SL, Michaels L, Alam CA. Pharmacokinetics of a new testosterone transdermal delivery system, TDS-testosterone in healthy males. Br J Clin Pharmacol. 2006 Mar;61(3):275-9. doi: 10.1111/j.1365-2125.2005.02542.x.
- 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.
Shern L. Chew, M.D., Ph.D. principal investigator
Consultant Physician and Professor of Endocrine Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Testosterone and Pump Sprayer in people with Hypogonadotropism, run by Transdermal Delivery Solutions Corp at 1 site 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 9 inclusion and 18 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: opening soon, as of the sponsor's last update on 30 Sep 2026. 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shern L. Chew, M.D., Ph.D. (011-44-20 034 6227, sl.chew@thelondonclinic.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Range Measure of serum levels of testosterone in response to varying doses (time frame: 1 week). 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 NCT01894308, 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 30 Sep 2026.