HypogonadismPhase 3NCT00448955
Open-Label Study of ARD-0403 in Testosterone Deficient Men
A Phase 3 study testing ARD-0403 in people with Hypogonadism, run by Ardana Bioscience Ltd at 12 sites in United States.
Trial summary
Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient wellbeing. The purpose of this study is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement therapy in testosterone deficient men. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hypogonadism
- What is being tested?
- ARD-0403
- How many people
- 150 participants
- Where
- 12 sitesUnited States
- Study dates
- May 2007to Feb 2008
- Phase
- Phase 3
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Testosterone deficiency
Who cannot join
- Previous treatment with testosterone replacement therapy within 4 weeks
- Moderate-severe benign prostatic hypertrophy, or prostatic cancer
- Haematocrit >50%
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University
Chicago, Illinois, 60611-3008
Duke University Medical Center
Durham, North Carolina, 27706
Michael E. Debakey VAMC
Houston, Texas, 77030
Medical Affiliated Research Center, Inc
Huntsville, Alabama, 35801
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health and Science University
Portland, Oregon, 97239
dgd Research
San Antonio, Texas, 78229-4801
VA Puget Sound Health Care System
Seattle, Washington, 98493
Stanford University
Stanford, California, 94305-5826
Los Angeles Biomedical Research Institute at Harbor-UCLA
Torrance, California, 90502
About this study
Official title: A Phase III Open-Label Study of the Efficacy and Safety of ARD-0403, a Testosterone Cream, in Testosterone Deficient Men
Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient wellbeing. The purpose of this study is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement therapy in testosterone deficient men.
- Conditions
- Hypogonadism
- Being tested
- ARD-0403
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARD-0403Drug
ARD-0403
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic
Secondary outcomes (1)
Safety and tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study startMay 2007
- Primary completionFeb 2008
- Study completionFeb 2008
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ardana Bioscience Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448955
- Sponsor's protocol ID
- ARD-0403-004
- Status last verified
- Apr 2008
- First submitted
- 16 Mar 2007
- Last updated
- 18 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Open-Label Study of the Efficacy and Safety of ARD-0403, a Testosterone Cream, in Testosterone Deficient Men
- ClinicalTrials.gov ID
- NCT00448955
- Acronym / sponsor ID
- ARD-0403-004
- Conditions
- Hypogonadism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ardana Bioscience LtdIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 19 Mar 2007 (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.
Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient wellbeing. The purpose of this study is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement therapy in testosterone deficient men.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Testosterone deficiency
Key exclusion criteria (3 listed)
- Previous treatment with testosterone replacement therapy within 4 weeks
- Moderate-severe benign prostatic hypertrophy, or prostatic cancer
- Haematocrit >50%
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 |
|---|---|---|
| ARD-0403ARD-0403 | Drug | – |
Primary outcome
Pharmacokinetic
1 secondary outcome
Safety and tolerability
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 18 Apr 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ARD-0403 in people with Hypogonadism, run by Ardana Bioscience Ltd at 12 sites in United States.
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 1 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 18 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Pharmacokinetic. 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 18 Apr 2008.