Adult Male HypogonadismPhase 3NCT02149264
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males
A Phase 3 study testing Testosterone gel (FE 999303) in people with Adult Male Hypogonadism, run by Ferring Pharmaceuticals at 22 sites in United States.
Trial summary
This is a phase 3, open-label, non-randomized, clinical trial to evaluate the efficacy and safety of FE 999303 (Testosterone gel) in adult hypogonadal males. 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
- 160 participants
- Where
- 22 sitesUnited States
- Study dates
- Jul 2014to Jun 2015
- 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 fasting serum testosterone levels <300 ng/dL
Who cannot join
- Previous use of the study drug
- History of prostate or breast cancer
- Prostate-Specific Antigen (PSA) ≥3 ng/mL
- Subject is sexually active and not willing to use adequate contraception
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Investigational site
Anniston, Alabama
Investigational site
Aventura, Florida
Investigational site
Bala-Cynwyd, Pennsylvania
Investigational site
Clearwater, Florida
Investigational site
Denver, Colorado
Investigational site
Edison, New Jersey
Investigational site
Garden City, New York
Investigational site
Huntsville, Alabama
Investigational site
Lawrence, New Jersey
Investigational site
Mishawaka, Indiana
Investigational site
Mt. Pleasant, South Carolina
Investigational site
Nashville, Tennessee
Investigational site
New Haven, Connecticut
Investigational site
New York, New York
Investigational site
Newport Beach, California
Investigational site
Norfolk, Virginia
Investigational site
Poughkeepsie, New York
Investigational site
Purchase, New York
Investigational site
Troy, Michigan
Investigational site
Warwick, Rhode Island
Investigational site
Watertown, Massachusetts
Investigational site
Webster, Texas
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, open-label, non-randomized, clinical trial to evaluate the efficacy and safety of FE 999303 (Testosterone gel) in adult hypogonadal males.
- 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 at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm. 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 Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL
The data were presented using descriptive statistics. The 95% confidence interval (CI) of the proportion (response) was estimated using the normal approximation to the binomial distribution. The study was considered to have met its efficacy criteria if the percentage was ≥ 75% and the lower bound of the 95% CI was ≥ 65%.
Measured: At Day 90
Secondary outcomes (9)
The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL
The data were presented using descriptive statistics. No statistical analysis was performed.
Measured: At 14, 35 and 56
Change From Baseline in International Index of Erectile Function (IIEF) Score
Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains were:
- 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: At Days 35 and 90
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score
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 (categorical in nature) are scored from 1-4. The scores are 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. The GFI ranged from 1 (no fatigue) to 50 (severe fatigue).
Measured: At Days 35 and 90
Change From Baseline in Short Form-12 Health Survey (SF-12) Score
Data collected from the SF-12 questionnaire, based on the norm-based scores was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contained four sub-domains:
PCS:
- Physical Functioning (2 items, questions 2-3)
- Role-Physical (2 items, questions 4-5)
- Bodily Pain (1 item, question 8)
- General Health (1 item, question 1)
MCS:
- Vitality (1 item, question 10)
- Social Functioning (1 item, question 12)
- Role-Emotional (2 items, questions 6-7)
- Mental Health (2 items, questions 9 and 11)
PCS and MCS composite scores are computed using the scores of the 12 questions and range from 0-100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Positive change from baseline indicated improvement in physical and mental health.
Measured: At Days 35 and 90
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone and dihydrotestosterone.
Measured: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.
Measured: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.
Measured: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.
Measured: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.
Measured: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose 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 May 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionJun 2015
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
- 160 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
- NCT02149264
- Sponsor's protocol ID
- 000127
- Status last verified
- Sep 2017
- First submitted
- 19 May 2014
- 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
- NCT02149264
- Acronym / sponsor ID
- 000127
- Conditions
- Adult Male Hypogonadism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Posted 28 Jul 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, open-label, non-randomized, clinical trial to evaluate the efficacy and safety of FE 999303 (Testosterone gel) in adult hypogonadal males.
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 at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males between 18-75 years of age
- Two fasting serum testosterone levels <300 ng/dL
Key exclusion criteria (4 listed)
- Previous use of the study drug
- History of prostate or breast cancer
- Prostate-Specific Antigen (PSA) ≥3 ng/mL
- Subject is sexually active and not willing to use adequate contraception
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 Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL
Time frame: At Day 90
The data were presented using descriptive statistics. The 95% confidence interval (CI) of the proportion (response) was estimated using the normal approximation to the binomial distribution. The study was considered to have met its efficacy criteria if the percentage was ≥ 75% and the lower bound of the 95% CI was ≥ 65%.
9 secondary outcomes
The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL
Time frame: At 14, 35 and 56
Change From Baseline in International Index of Erectile Function (IIEF) Score
Time frame: At Days 35 and 90
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score
Time frame: At Days 35 and 90
Change From Baseline in Short Form-12 Health Survey (SF-12) Score
Time frame: At Days 35 and 90
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Time frame: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Time frame: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
Time frame: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Time frame: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Time frame: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90
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
22 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 Testosterone gel (FE 999303) in people with Adult Male Hypogonadism, run by Ferring Pharmaceuticals at 22 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 2 inclusion and 4 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 22 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?
Yes. Results are posted in the registry (first posted 28 Jul 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 Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL (time frame: At 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.