Adult Male HypogonadismPhase 3NCT01703741
A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel
A Phase 3 study testing Testosterone Gel (FE 999093) in people with Adult Male Hypogonadism, run by Ferring Pharmaceuticals at 18 sites in 2 countries.
Trial summary
This is a multicenter extension trial in adult hypogonadal males. The purpose of this study is to evaluate the safety of testosterone gel delivered using an applicator over an extended period of time. 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 999093)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Dec 2012to Oct 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
- Completion of the Phase 3 protocol (NCT01665599)
Who cannot join
- Use of another investigational product
- Use of any medications that could be considered anabolic or interfere with androgen metabolism
- Use of estrogens, gonadotropin releasing hormone agonists/antagonists, antiandrogens, or human growth hormone
- Use of another testosterone product
- Chronic use of any drug of abuse
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States16 sites
South Florida Medical Research
Aventura, Florida
Tristate Urologic Services
Cincinnati, Ohio
Urology Clinics of North Texas
Dallas, Texas
Medical Affiliated Research Center
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
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 Multicenter Extension Trial to Evaluate the Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males
This is a multicenter extension trial in adult hypogonadal males. The purpose of this study is to evaluate the safety of testosterone gel delivered using an applicator over an extended period of time.
- Conditions
- Adult Male Hypogonadism
- Being tested
- Testosterone Gel (FE 999093)
- 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 999093)Drug
| Study group | Role | What they receive |
|---|---|---|
| Testosterone gel (FE 999093) | Experimental | Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months. Receives: Drug: Testosterone Gel (FE 999093) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL
Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics.
Measured: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
Secondary outcomes (12)
Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL.
Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics.
Measured: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
Domain Scores for the International Index of Erectile Function (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 1-10 and a score of 1-5 is awarded to questions 11-15. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function, in each domain.
Measured: At Month 6
Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire
In ADAM questionnaire, subjects had to respond in "yes or no" to 10 questions. A positive result (with severity and symptoms of low testosterone) on the questionnaire was defined as an affirmative answer ("yes") to questions 1 or 7, or to any 3 other questions.
The data were presented using descriptive statistics.
Measured: At Month 6
Domain Scores for the Multidimensional Assessments 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 scores of 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: At Month 6
Domain Scores for the Short Form-12 (SF-12) 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 SD 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: At Month 6
Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL
The data were presented using descriptive statistics.
Measured: At Month 3
Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL
The data were presented using descriptive statistics.
Measured: At Month 6
Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics.
Measured: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone
Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics.
Measured: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics.
Measured: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics.
Measured: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics.
Measured: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionOct 2013
- Study completionOct 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
- 145 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
- NCT01703741
- Sponsor's protocol ID
- 000077
- Status last verified
- Sep 2017
- First submitted
- 4 Oct 2012
- Last updated
- 6 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 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Extension Trial to Evaluate the Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males
- ClinicalTrials.gov ID
- NCT01703741
- Acronym / sponsor ID
- 000077
- Conditions
- Adult Male Hypogonadism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 10 Oct 2012 (estimated)
- Results
- Posted 6 Oct 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 multicenter extension trial in adult hypogonadal males. The purpose of this study is to evaluate the safety of testosterone gel delivered using an applicator over an extended period of time.
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 999093) | Experimental | Drug: Testosterone Gel (FE 999093)Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Completion of the Phase 3 protocol (NCT01665599)
Key exclusion criteria (5 listed)
- Use of another investigational product
- Use of any medications that could be considered anabolic or interfere with androgen metabolism
- Use of estrogens, gonadotropin releasing hormone agonists/antagonists, antiandrogens, or human growth hormone
- Use of another testosterone product
- Chronic use of any drug of abuse
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 999093) | Drug | Testosterone gel (FE 999093) |
Primary outcome
Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL
Time frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics.
12 secondary outcomes
Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL.
Time frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire
Time frame: At Month 6
Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire
Time frame: At Month 6
Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire
Time frame: At Month 6
Domain Scores for the Short Form-12 (SF-12) Questionnaire
Time frame: At Month 6
Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL
Time frame: At Month 3
Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL
Time frame: At Month 6
Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Time frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone
Time frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Time frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Time frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Time frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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
18 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 999093) in people with Adult Male Hypogonadism, run by Ferring Pharmaceuticals at 18 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 1 inclusion and 5 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 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 18 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 6 Oct 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?
Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL (time frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)). 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 Oct 2017.