HypogonadismPhase 3NCT00522431
A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone
A Phase 3 study testing Testosterone in people with Hypogonadism, run by Endo USA Inc., a Keenova Therapeutics Company.
Trial summary
Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Hypogonadism
- What is being tested?
- Testosterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Mar 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men aged 18 - 75 years with primary or secondary hypogonadism as confirmed by:
- Single serum total testosterone concentration < 250 ng/dL, or
- Two consecutive serum total testosterone concentrations < 300 ng/dL (determined at least one week apart during the screening period).
- Has a BMI ≥ 22 kg/m2 and < 35 kg/m2.
Who cannot join
None listed.
About this study
Official title: An Open Label Phase 3 Study of Fortigel Testosterone Gel 2% in Hypogonadal Males
Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.
The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18 to 75 years. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of Fortigel, which will be applied to the skin each day throughout the study period.
- Conditions
- Hypogonadism
- Being tested
- Testosterone
- Keywords
- Hypogonadism
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Also called Fortigel
2% gel
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 2% testosterone gel Receives: Drug: Testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90
Percentage of participants with Cavg0-24h ≥300-≤1140 ng/dL
Measured: 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90
Secondary outcomes (1)
Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90
Percentage of participants with Cmax ≤1500 ng/dL, 1800-2500 ng/dL, and >2500 ng/dL
Measured: 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liz Waldie, Study director, Strakan Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522431
- Sponsor's protocol ID
- FOR01C
- Status last verified
- Sep 2017
- First submitted
- 28 Aug 2007
- Last updated
- 5 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase 3 Study of Fortigel Testosterone Gel 2% in Hypogonadal Males
- ClinicalTrials.gov ID
- NCT00522431
- Acronym / sponsor ID
- FOR01C
- Conditions
- Hypogonadism
- Keywords
- Hypogonadism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 29 Aug 2007 (estimated)
- Results
- Posted 7 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.
The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18 to 75 years. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of Fortigel, which will be applied to the skin each day throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Testosterone2% testosterone gel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men aged 18 - 75 years with primary or secondary hypogonadism as confirmed by:
- Has a BMI ≥ 22 kg/m2 and < 35 kg/m2.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TestosteroneAlso: Fortigel2% gel | Drug | 1 |
Primary outcome
Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90
Percentage of participants with Cavg0-24h ≥300-≤1140 ng/dL
1 secondary outcome
Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hypogonadism
RecruitingObservational study
Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism
Hypogonadism, Male, Endocrine Disease
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Hypogonadism, Male
RecruitingPhase 4
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Prostate Cancer, Hypogonadism, Male
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
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.
Liz Waldie study director
Strakan Pharmaceuticals, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Testosterone in people with Hypogonadism, run by Endo USA Inc., a Keenova Therapeutics Company.
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 4 inclusion and 0 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 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 7 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90 (time frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90). 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 5 Oct 2017.