Adult Male HypogonadismPhase 3NCT01665599
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel
A Phase 3 study testing Testosterone gel (FE 999303) in people with Adult Male Hypogonadism, run by Ferring Pharmaceuticals at 19 sites in 2 countries.
Trial summary
This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the safety and efficacy of testosterone gel (2%) delivered using an applicator. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Adult Male Hypogonadism
- What is being tested?
- Testosterone gel (FE 999303)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Jul 2012to May 2013
- 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
- Males between 18-75 years of age
- Two screening serum testosterone values less than 300 ng/dL
- One or more symptoms of testosterone deficiency
Who cannot join
- Previous use of the investigational product
- Use of any investigational product within 30 days prior to screening and during the study
- BMI less than 18 kg/m^2 or more than 35 kg/m^2
- Prostatic mass(es)
- Generalized skin irritation or skin disease
- Lower urinary tract obstruction
Show all 22Show fewer
- Myocardial infarction or cerebrovascular accident in the last 6 months
- Unstable angina or congestive heart failure
- Thromboembolic disorders
- Sleep apnea
- Hyperparathyroidism or uncontrolled diabetes
- Untreated moderate to severe depression
- History of testicular, prostate, or breast cancer
- HIV, Hepatitis B, or Hepatitis C positive
- PSA more or equal to 3 ng/mL
- Use of any medications that could be considered anabolic
- Use of estrogens, Gonadotropin Releasing Hormone agonists/antagonists, antiandrogens, or human Growth Hormone
- Chronic use of any drug of abuse
- Involvement in a sport in which there is a screening for anabolic steroids
- Not willing to use adequate contraception during the study
- Partner is pregnant and/or breast feeding
- Partner has a history of breast, uterine or ovarian cancer
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States17 sites
South Florida Medical Research
Aventura, Florida
Tristate Urologic Services
Cincinnati, Ohio
Urology Clinics of North Texas
Dallas, Texas
Medical Affiliated Research Cente
Huntsville, Alabama
Premier Urology Associates
Lawrenceville, New Jersey
Connecticut Clinical Research
Middlebury, Connecticut
Coastal Carolina Research Center
Mt. Pleasant, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina
Clinical Research Associates
Nashville, Tennessee
University Urology
New York, New York
California Professional Research
Newport Beach, California
Quality Clinical Research
Omaha, Nebraska
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York
Michigan Institute of Urology
Saint Clair Shores, Michigan
San Diego Sexual Medicine
San Diego, California
Omega Medical Research
Warwick, Rhode Island
PMG Research of Wilmington
Winston-Salem, North Carolina
Canada2 sites
St. Joseph's Healthcare
London, Ontario
Private Practice and Clinical Research
North Bay, Ontario
About this study
Official title: A Phase 3, Open-label, Non-randomized, Clinical Trial to Evaluate the Efficacy and Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males
This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the safety and efficacy of testosterone gel (2%) delivered using an applicator.
- Conditions
- Adult Male Hypogonadism
- Being tested
- Testosterone gel (FE 999303)
- Medical subject headings
- Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone gel (FE 999303)Drug
| Study group | Role | What they receive |
|---|---|---|
| Testosterone gel (FE 999303) | Experimental | Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion. Receives: Drug: Testosterone gel (FE 999303) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
The data were presented using descriptive statistics. No statistical analysis was performed.
Measured: Day 90
Secondary outcomes (16)
The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
The data were presented using descriptive statistics. No statistical analysis was performed.
Measured: Day 1
Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)
A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone.
Measured: Day 1; Day 90
Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)
A validated LC/MS/MS method was used to determine the levels of total testosterone.
Measured: Day 1; Day 90
Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)
A validated LC/MS/MS method was used to determine the levels of total testosterone.
Measured: Day 1; Day 90
Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)
A validated LC/MS/MS method was used to determine the levels of total testosterone.
Measured: Day 1; Day 90
Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)
A validated LC/MS/MS method was used to determine the levels of total testosterone.
Measured: Day 1; Day 90
Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)
A validated LC/MS/MS method was used to determine the levels of total testosterone.
Measured: Day 1; Day 90
Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ
A validated LC/MS/MS method was used to determine the levels of DHT.
Measured: Day 1; Day 90
Pharmacokinetics of DHT Measuring Tmax
A validated LC/MS/MS method was used to determine the levels of DHT.
Measured: Day 1; Day 90
Pharmacokinetics of DHT Measuring Cmax
A validated LC/MS/MS method was used to determine the levels of DHT.
Measured: Day 1; Day 90
Pharmacokinetics of DHT Measuring Cave
A validated LC/MS/MS method was used to determine the levels of DHT.
Measured: Day 1; Day 90
Pharmacokinetics of DHT Measuring Cmin
A validated LC/MS/MS method was used to determine the levels of DHT.
Measured: Day 1; Day 90
Pharmacokinetics of DHT Measuring Tmin
A validated LC/MS/MS method was used to determine the levels of DHT.
Measured: Day 1; Day 90
Change From Baseline in the International Index of Erectile Dysfunction (IIEF) Questionnaire
Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains are:
- Erectile function (6 items, questions 1-5 and 15) (Score range: 1-30)
- Orgasmic function (2 items, questions 9-10) (Score range: 0-10)
- Sexual desire (2 items, questions 11-12) (Score range: 2-10)
- Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15)
- Overall satisfaction (2 items, questions 13-14) (Score range: 2-10)
A score of 0-5 is awarded to questions 1 to 10 and a score of 1-5 is awarded to questions 11 to 15. Total score was calculated by summing up scores of each domain and ranged from 5 to 75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function.
Measured: Day 91
Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire
The MAF contains four sub-domains:
- Severity (2 items, questions 1-2) (Score range: 2-20)
- Distress (1 item, question 3) (Score range: 1-10)
- Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110)
- Timing (2 items, questions 15-16) (Score range: 5-20)
A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain is categorical and was converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue.
To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. Range of GFI: 1 (no fatigue) to 50 (severe fatigue).
The data were presented using descriptive statistics.
Measured: Day 91
Change From Baseline in the SF-12 Health Questionnaire
Data collected from the SF-12 questionnaire was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contains four sub-domains:
PCS: General Health (1 item), Physical Functioning (2 items), Role-Physical (2 items), Bodily Pain (1 item)
MCS: Role-Emotional (2 items), Mental Health (2 items), Vitality (1 item), Social Functioning (1 item)
The scale scores are calculated by summing responses across scale items and then transforming these raw scores to a 0-100 scale. Computerized scoring algorithms are used to produce norm-based scores for each scale (mean of 50 and standard deviation of 10) as well as the PCS and MCS summary scores. A zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
The data were presented using descriptive statistics.
Measured: Day 91
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2013
- Study completionMay 2013
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 Adult Male 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665599
- Sponsor's protocol ID
- 000023
- Status last verified
- Sep 2017
- First submitted
- 1 Aug 2012
- Last updated
- 26 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-label, Non-randomized, Clinical Trial to Evaluate the Efficacy and Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males
- ClinicalTrials.gov ID
- NCT01665599
- Acronym / sponsor ID
- 000023
- Conditions
- Adult Male Hypogonadism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 15 Aug 2012 (estimated)
- Results
- Posted 20 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the safety and efficacy of testosterone gel (2%) delivered using an applicator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Testosterone gel (FE 999303) | Experimental | Drug: Testosterone gel (FE 999303)Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations. Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males between 18-75 years of age
- Two screening serum testosterone values less than 300 ng/dL
- One or more symptoms of testosterone deficiency
Key exclusion criteria (22 listed)
- Previous use of the investigational product
- Use of any investigational product within 30 days prior to screening and during the study
- BMI less than 18 kg/m^2 or more than 35 kg/m^2
- Prostatic mass(es)
- Generalized skin irritation or skin disease
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 |
|---|---|---|
| Testosterone gel (FE 999303) | Drug | Testosterone gel (FE 999303) |
Primary outcome
The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
Time frame: Day 90
The data were presented using descriptive statistics. No statistical analysis was performed.
16 secondary outcomes
The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
Time frame: Day 1
Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)
Time frame: Day 1; Day 90
Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)
Time frame: Day 1; Day 90
Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)
Time frame: Day 1; Day 90
Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)
Time frame: Day 1; Day 90
Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)
Time frame: Day 1; Day 90
Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)
Time frame: Day 1; Day 90
Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ
Time frame: Day 1; Day 90
Pharmacokinetics of DHT Measuring Tmax
Time frame: Day 1; Day 90
Pharmacokinetics of DHT Measuring Cmax
Time frame: Day 1; Day 90
Pharmacokinetics of DHT Measuring Cave
Time frame: Day 1; Day 90
Pharmacokinetics of DHT Measuring Cmin
Time frame: Day 1; Day 90
Pharmacokinetics of DHT Measuring Tmin
Time frame: Day 1; Day 90
Change From Baseline in the International Index of Erectile Dysfunction (IIEF) Questionnaire
Time frame: Day 91
Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire
Time frame: Day 91
Change From Baseline in the SF-12 Health Questionnaire
Time frame: Day 91
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Testosterone gel (FE 999303) in people with Adult Male Hypogonadism, run by Ferring Pharmaceuticals at 19 sites in 2 countries.
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 3 inclusion and 22 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 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 20 Sep 2017). 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?
The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL (time frame: 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 26 Oct 2017.