HypogonadismNCT01172366
A Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application
An observational study of Hypogonadism, run by Acrux DDS Pty Ltd at 1 site in Australia.
Trial summary
The hypotheses for this study is that there is no transfer of testosterone from male (donor) subjects to female (recipient) subjects when contact is made 2 hours post application of 2% Testosterone MD-Lotion® if the donor has a covered application area with a T-shirt. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2010to Sep 2010
- Phase
- Observational
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy male and female volunteers
Who may be able to join
- Healthy male subjects aged ≥ 18 and ≤ 45, who have no history of clinically significant medical disorders and who have passed the required laboratory and physical screening tests.
- Healthy premenopausal women aged ≥ 18 and ≤ 45, who have no history of clinically significant medical disorders and who have passed the required laboratory and physical screening tests.
Who cannot join
- Men with a history of allergy/sensitivity to testosterone or in whom testosterone therapy is contraindicated, or a clinically significant finding on physical exam or skin disorder.
- Healthy Female Subjects:
- Women with a history of allergy/sensitivity to testosterone or in whom testosterone therapy is contraindicated, or a clinically significant finding on physical exam or skin disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application of 2% Testosterone Metered Dose (MD) Lotion®
The hypotheses for this study is that there is no transfer of testosterone from male (donor) subjects to female (recipient) subjects when contact is made 2 hours post application of 2% Testosterone MD-Lotion® if the donor has a covered application area with a T-shirt.
- Conditions
- Hypogonadism
- Keywords
- Open label, single dose, pharmacokinetic study
- Medical subject headings
- Hypogonadism
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Single dose pharmacokinetic parameters (AUC0-24, AUC0-72, Cmin, Cmax, and tmax) are to be reported for total testosterone, free testosterone and DHT.
Measured: 72 hours total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2010
- Study completionSep 2010
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
- Observational
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acrux DDS Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tina Soulis, BSc, PhD, Study director, Acrux DDS Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172366
- Sponsor's protocol ID
- MTE12
- Status last verified
- Aug 2010
- First submitted
- 28 Jul 2010
- Last updated
- 6 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application of 2% Testosterone Metered Dose (MD) Lotion®
- ClinicalTrials.gov ID
- NCT01172366
- Acronym / sponsor ID
- MTE12
- Conditions
- Hypogonadism
- Keywords
- Open label, single dose, pharmacokinetic study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Acrux DDS Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 29 Jul 2010 (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.
The hypotheses for this study is that there is no transfer of testosterone from male (donor) subjects to female (recipient) subjects when contact is made 2 hours post application of 2% Testosterone MD-Lotion® if the donor has a covered application area with a T-shirt.
Study design
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy male and female volunteers
Key inclusion criteria (2 listed)
- Healthy male subjects aged ≥ 18 and ≤ 45, who have no history of clinically significant medical disorders and who have passed the required laboratory and physical screening tests.
- Healthy premenopausal women aged ≥ 18 and ≤ 45, who have no history of clinically significant medical disorders and who have passed the required laboratory and physical screening tests.
Key exclusion criteria (3 listed)
- Men with a history of allergy/sensitivity to testosterone or in whom testosterone therapy is contraindicated, or a clinically significant finding on physical exam or skin disorder.
- Women with a history of allergy/sensitivity to testosterone or in whom testosterone therapy is contraindicated, or a clinically significant finding on physical exam or skin disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pharmacokinetics
Time frame: 72 hours total
Single dose pharmacokinetic parameters (AUC0-24, AUC0-72, Cmin, Cmax, and tmax) are to be reported for total testosterone, free testosterone and DHT.
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 6 Sep 2010.
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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.
Tina Soulis, BSc, PhD study director
Acrux DDS Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypogonadism, run by Acrux DDS Pty Ltd at 1 site in Australia.
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 2 inclusion and 3 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 6 Sep 2010. 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 Australia. 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.
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?
Pharmacokinetics (time frame: 72 hours total). 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 6 Sep 2010; AzTrials last refreshed its copy on 28 Oct 2026.