Male HypogonadismPhase 3NCT01228071
Time to Eugonadal Range, Time to Steady State and Drying Time
A Phase 3 study testing testosterone gel 2% in people with Male Hypogonadism, run by Endo USA Inc., a Keenova Therapeutics Company at 8 sites in United States.
Trial summary
This is a multicenter, open-label, single arm trial to evaluate the time to eugonadal testosterone range after initial testosterone gel 2% application, time to steady state after after initiation of testosterone gel 2%, and drying time after application of testosterone gel 2%. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Male Hypogonadism
- What is being tested?
- testosterone gel 2%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2010to May 2011
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged 18 to 65 years.
- Have a diagnosis of primary or secondary hypogonadism with a:
- Single morning serum total testosterone concentration <250 ng/dL or
- Two (2) consecutive morning serum total testosterone concentrations <300 ng/dL (determined at least 1 week apart during a 3 week screening period) Total serum testosterone sampling must occur between 7 AM and 11 AM at screening
- Have a body mass index (BMI) ≥22 kg/m2 and ≤35 kg/m2.
- Have a hematocrit level ≤50% at screening
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- Use of reliable contraception for subjects who have sexual partners of childbearing potential (women not of childbearing potential are defined as postmenopausal, ie, amenorrhea ≥1 year or permanently sterile). Reliable methods of contraception are:
- Barrier type devices (eg, condom, female condom, diaphragm, contraceptive sponge) only in combination with a spermicide.
- Intra-uterine devices.
- Oral, injectable, transdermal or implantable hormonal contraceptives.
- Is able to understand and give written informed consent
Who cannot join
- Severe concomitant illness, which in the opinion of the Investigator, may put the subject at risk when participating in the trial or may influence the results of the trial or affect the subjects' ability to take part in the trial.
- Acute or chronic renal impairment [(Cr ≥ 1.5x ULN (upper limit of normal)].
- Acute or chronic hepatic impairment will be excluded.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >2.5 × ULN (upper limit of normal).
- Clinically significant, abnormal, baseline laboratory result(s), which in the opinion of the Investigator affect(s) the subject's suitability for the trial.
- History of, or any existing, clinically significant cardiac disease (New York Heart Association [NYHA] Class III and IV).
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- Clinically significant electrocardiogram (ECG) abnormalities such as QTcB or QTcF ≥450 msec; or QTc ≥480 msec in subjects with bundle branch block.
- Prostate specific antigen (PSA) level >4 ng/mL.
- An abnormality on digital rectal examination deemed to be suspicious or worrisome for cancer, such as a nodule or asymmetric induration.
- Severe symptomatic benign prostatic hyperplasia or International Prostate Symptom Score (IPSS) >19 (at screening).
- Sleep apnea which is untreated, or subjects with sleep apnea which is treated (including c-PAP treatment) but in the opinion of the investigator has been clinically unstable during the 3 months prior to screening.
- Current eczema, psoriasis, sunburn, or any other clinically significant skin condition at the application site.
- Current abrasions at site of application.
- Malignancy (or suspected malignancy) of any type except a basal cell carcinoma. Subjects with a history of malignancy must have a disease free status ≥5 years prior to starting study treatment. Subjects who have had prostate or breast cancer are not permitted to participate in the study.
- Known to be sensitive and/or has had an adverse skin reaction to testosterone hormone replacement therapy or topical products containing alcohol.
- Actively or potentially trying to start a family or requiring fertility treatment or with a spouse/partner who is pregnant.
- Participated in any experimental drug or device study within 30 days prior to starting study treatment.
- History of alcohol or substance abuse within the last year.
- Taking opioids for any reason within 3 days of screening
- Receiving the following medications:
- Androgen treatments.
- Androgen antagonists.
- Application of any lotions, ointments, or steroids to the application site.
- 5alpha-reductase inhibitors (eg, finasteride, dutasteride).
- Any subjects receiving testosterone hormone replacement treatments must abide by the indicated washout period prior to screening total serum testosterone measurement
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Men's Health Boston
Brookline, Massachusetts, 02445
Matrix Research, LLC
Greer, South Carolina, 29650
Connecticut Clinical Research
Middlebury, Connecticut, 06762
Compass Research East, LLC
Oviedo, Florida, 32765
Cetero Research
San Antonio, Texas, 78229
Southeastern Research Group, Inc.
Tallahassee, Florida, 32308
Tory Internal Medicine, PC
Troy, Michigan, 48098
Quality of Life Medical & Research Center
Tucson, Arizona, 85712
About this study
Official title: Assessment of Time to Eugonadal Testosterone Range After Initial Fortesta (Testosterone) Gel 2% Application, Time to Steady State After Initiation of Fortesta, And Gel Drying Time After Fortesta Application
This is a multicenter, open-label, single arm trial to evaluate the time to eugonadal testosterone range after initial testosterone gel 2% application, time to steady state after after initiation of testosterone gel 2%, and drying time after application of testosterone gel 2%.
Read the detailed description
Assessment of Time to Eugonadal Testosterone Range After Initial Fortesta (Testosterone) Gel 2% Application, Time to Steady State After Initiation of Fortesta, And Gel Drying Time After Fortesta Application
- Conditions
- Male Hypogonadism
- Being tested
- testosterone gel 2%
- Keywords
- testosterone deficiency, hypogonadism
- Medical subject headings
- Eunuchism, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testosterone gel 2%Drug
Also called EN3350
40 mg testosterone gel 2%
| Study group | Role | What they receive |
|---|---|---|
| 40 mg daily dose of testosterone gel 2% | Experimental | testosterone gel 2% Receives: Drug: testosterone gel 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Target Eugonadal Range
The time to eugonadal range (ie, testosterone ≥300 ng/dL) was assessed based on the 24-hour PK serum concentration data.
Measured: 24 hours
Time to Steady State (SS)
Trough total testosterone levels were obtained at Day 2, Day 3, Day 4, Day 7, and Day 14 to assess time to steady state. Trough concentrations over the 14-day period were used to calculate time SS.
Measured: 14 days
Gel Drying Time
Testosterone gel 2% drying time was assessed with a stopwatch. On Day 14 at the time of application of the gel directly to the first anteromedial thigh, the subject started a stopwatch. The gel was spread as evenly as possible over an area of 1 g/100 cm2. The total coverage area on the thigh was approximately equal to two (2) 3"× 5" postcards. The subject gently rubbed the gel with his fingertip in a circular motion (avoiding contact with the scrotal region) until the gel was dry. At this time, the stopwatch was stopped and the time expended was recorded in the eCRF.
Measured: 1 day; drying time measured following gel application on Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionMay 2011
- Study completionMay 2011
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 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228071
- Sponsor's protocol ID
- EN3350-302
- Status last verified
- Sep 2017
- First submitted
- 22 Oct 2010
- Last updated
- 5 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 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Time to Eugonadal Testosterone Range After Initial Fortesta (Testosterone) Gel 2% Application, Time to Steady State After Initiation of Fortesta, And Gel Drying Time After Fortesta Application
- ClinicalTrials.gov ID
- NCT01228071
- Acronym / sponsor ID
- EN3350-302
- Conditions
- Male Hypogonadism
- Keywords
- testosterone deficiency, hypogonadism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2010 (actual)
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 25 Oct 2010 (estimated)
- Results
- Posted 22 Jul 2013
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, open-label, single arm trial to evaluate the time to eugonadal testosterone range after initial testosterone gel 2% application, time to steady state after after initiation of testosterone gel 2%, and drying time after application of testosterone gel 2%.
Detailed description
Assessment of Time to Eugonadal Testosterone Range After Initial Fortesta (Testosterone) Gel 2% Application, Time to Steady State After Initiation of Fortesta, And Gel Drying Time After Fortesta Application
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 40 mg daily dose of testosterone gel 2% | Experimental | Drug: testosterone gel 2%testosterone gel 2% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men aged 18 to 65 years.
- Have a diagnosis of primary or secondary hypogonadism with a:
- Have a body mass index (BMI) ≥22 kg/m2 and ≤35 kg/m2.
- Have a hematocrit level ≤50% at screening
- Use of reliable contraception for subjects who have sexual partners of childbearing potential (women not of childbearing potential are defined as postmenopausal, ie, amenorrhea ≥1 year or permanently sterile). Reliable methods of contraception are:
Key exclusion criteria (25 listed)
- Severe concomitant illness, which in the opinion of the Investigator, may put the subject at risk when participating in the trial or may influence the results of the trial or affect the subjects' ability to take part in the trial.
- Acute or chronic renal impairment [(Cr ≥ 1.5x ULN (upper limit of normal)].
- Acute or chronic hepatic impairment will be excluded.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >2.5 × ULN (upper limit of normal).
- Clinically significant, abnormal, baseline laboratory result(s), which in the opinion of the Investigator affect(s) the subject's suitability for the trial.
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 2%Also: EN335040 mg testosterone gel 2% | Drug | 40 mg daily dose of testosterone gel 2% |
Primary outcome
Time to Target Eugonadal Range
Time frame: 24 hours
The time to eugonadal range (ie, testosterone ≥300 ng/dL) was assessed based on the 24-hour PK serum concentration data.
Time to Steady State (SS)
Time frame: 14 days
Trough total testosterone levels were obtained at Day 2, Day 3, Day 4, Day 7, and Day 14 to assess time to steady state. Trough concentrations over the 14-day period were used to calculate time SS.
Gel Drying Time
Time frame: 1 day; drying time measured following gel application on Day 14
Testosterone gel 2% drying time was assessed with a stopwatch. On Day 14 at the time of application of the gel directly to the first anteromedial thigh, the subject started a stopwatch. The gel was spread as evenly as possible over an area of 1 g/100 cm2. The total coverage area on the thigh was approximately equal to two (2) 3"× 5" postcards. The subject gently rubbed the gel with his fingertip in a circular motion (avoiding contact with the scrotal region) until the gel was dry. At this time, the stopwatch was stopped and the time expended was recorded in the eCRF.
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.
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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.
8 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 2% in people with Male Hypogonadism, run by Endo USA Inc., a Keenova Therapeutics Company at 8 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 11 inclusion and 25 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.
Where is the study taking place?
The record lists 8 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 22 Jul 2013). 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?
Time to Target Eugonadal Range (time frame: 24 hours). The study lists 3 primary outcomes in all. 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.