Hypogonadal MalesPhase 2NCT01464879

A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator

A Phase 2 study testing Testosterone Gel (FE 999303) in people with Hypogonadal Males, run by Ferring Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase 2 clinical trial in adult hypogonadal males with baseline morning serum testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the pharmacokinetics of FE 999303, delivered using an applicator in comparison to hand application Read more about this study

Who is it for?: Ages 18 to 75 years, men only
Conditions the study is for: Hypogonadal Males
What is being tested?: Testosterone Gel (FE 999303)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Dec 2011to May 2012
Phase: Phase 2
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

Ages 18-75
History of hypogonadism
In good health based on medical history, physical examination, and clinical laboratory tests
Serum testosterone deficiency
One or more symptom(s) of testosterone deficiency (i.e. fatigue, reduced libido, or reduced sexual functioning)
Body mass index (BMI) between 18 and 35 kg/m^2
All screening lab tests within 20% of the normal range (exceptions are liver function tests)
HIV, Hepatitis B and C negative

Who cannot join

Previous use of FE 999303
Prostate cancer
Breast carcinoma, patient or partner
Palpable prostatic mass(es)
Serum PSA levels ≥3 ng/dL
Chronic use of any drug of abuse

Show all 17Show fewer

Lower urinary tract obstruction
Clinically significant anemia or renal dysfunction
Cardiovascular disease
Hyperparathyroidism or uncontrolled diabetes
Generalized skin irritation or significant skin disease
Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, 5-alfa-reductase-inhibitors, ketoconazole, abiraterone)
Use of estrogens, GnRH agonists/antagonist, antiandrogens, human GH (within previous 12 months of screening)
Use of testosterone products (within 8 weeks of screening for parenteral products, or 6 weeks of screening for other preparations)
Sleep apnea
Untreated depression
Subject with a partner who is pregnant or will not use contraception

Trial locations and contacts

1 site in 1 country.

United States1 site

AccuMed Research Associates
Garden City, New York

Other trials in United States

About this study

Official title: A Phase 2, Open-Label, Sequential Dose Escalation Study in Adult Hypogonadal Males to Evaluate the Pharmacokinetics of Three Volumes of FE 999303 (Testosterone Gel), Applied to the Shoulder/Upper Arm, Using an Applicator Compared With Hand Application

Conditions: Hypogonadal Males
Being tested: Testosterone Gel (FE 999303)

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 groups in NCT01464879
Study group	Role	What they receive
Testosterone 2.50 mL (hand)	Experimental	Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm every day for seven days. Receives: Drug: Testosterone Gel (FE 999303)
Testosterone 1.25 mL (applicator)	Experimental	Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm every day for seven days. Receives: Drug: Testosterone Gel (FE 999303)
Testosterone 2.50 mL (applicator)	Experimental	Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm every day for seven days. Receives: Drug: Testosterone Gel (FE 999303)
Testosterone 3.75 mL (applicator)	Experimental	Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, every day for seven days. Receives: Drug: Testosterone Gel (FE 999303)

What is being measured

The primary outcome is the main question the study is designed to answer.

Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator.
Descriptive statistics was used to present the outcome results.
Measured: Days 15-21, Days 22-28 & Days 29-35

Secondary outcomes (13)

Responder Rate: Percentage of Subjects Whose Cavg Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With One Volume of FE 999303 Applied by Hand.
Measured: Days 1-7
Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ)
Measured: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax)
Measured: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax)
Measured: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Pharmacokinetics of Total Testosterone and DHT Measuring Cavg
Measured: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin)
Measured: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin)
Measured: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ
Measured: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Pharmacokinetics of Total Testosterone and DHT Measuring Tmax
Measured: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Pharmacokinetics of Total Testosterone and DHT Measuring Cmax
Measured: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Pharmacokinetics of Total Testosterone and DHT Measuring Cavg
Measured: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Pharmacokinetics of Total Testosterone and DHT Measuring Cmin
Measured: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Pharmacokinetics of Total Testosterone and DHT Measuring Tmin
Measured: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011May 2012

First posted4 Nov 2011 (estimated)
Study startDec 2011
Primary completionMay 2012
Study completionMay 2012

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 Hypogonadal MalesStudies 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01464879
Sponsor's protocol ID: 000024
Status last verified: Aug 2017
First submitted: 1 Nov 2011
Last updated: 13 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 4
Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer on Active Surveillance
Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8
Not yet recruitingPhase 2
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All Hypogonadal Males trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Open-Label, Sequential Dose Escalation Study in Adult Hypogonadal Males to Evaluate the Pharmacokinetics of Three Volumes of FE 999303 (Testosterone Gel), Applied to the Shoulder/Upper Arm, Using an Applicator Compared With Hand Application
ClinicalTrials.gov ID: NCT01464879
Acronym / sponsor ID: 000024
Conditions: Hypogonadal Males
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 4 Nov 2011 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Testosterone 2.50 mL (hand)	Experimental	Drug: Testosterone Gel (FE 999303)Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm every day for seven days.
Testosterone 1.25 mL (applicator)	Experimental	Drug: Testosterone Gel (FE 999303)Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm every day for seven days.
Testosterone 2.50 mL (applicator)	Experimental	Drug: Testosterone Gel (FE 999303)Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm every day for seven days.
Testosterone 3.75 mL (applicator)	Experimental	Drug: Testosterone Gel (FE 999303)Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, every day for seven days.

Who may qualify

Ages: 18 to 75 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Ages 18-75
History of hypogonadism
In good health based on medical history, physical examination, and clinical laboratory tests
Serum testosterone deficiency
One or more symptom(s) of testosterone deficiency (i.e. fatigue, reduced libido, or reduced sexual functioning)

Key exclusion criteria (17 listed)

Previous use of FE 999303
Prostate cancer
Breast carcinoma, patient or partner
Palpable prostatic mass(es)
Serum PSA levels ≥3 ng/dL

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 1.25 mL (applicator), Testosterone 2.50 mL (applicator), Testosterone 2.50 mL (hand), Testosterone 3.75 mL (applicator)

Primary outcome

Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator.
Time frame: Days 15-21, Days 22-28 & Days 29-35
Descriptive statistics was used to present the outcome results.

13 secondary outcomes

Responder Rate: Percentage of Subjects Whose Cavg Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With One Volume of FE 999303 Applied by Hand.
Time frame: Days 1-7
Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ)
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax)
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax)
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Pharmacokinetics of Total Testosterone and DHT Measuring Cavg
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin)
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin)
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Pharmacokinetics of Total Testosterone and DHT Measuring Tmax
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Pharmacokinetics of Total Testosterone and DHT Measuring Cmax
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Pharmacokinetics of Total Testosterone and DHT Measuring Cavg
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Pharmacokinetics of Total Testosterone and DHT Measuring Cmin
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Pharmacokinetics of Total Testosterone and DHT Measuring Tmin
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand

Results and safety

Results posted to the registry on 28 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Testosterone Topical	20	18

Primary outcome: Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator.

Time frame: Days 15-21, Days 22-28 & Days 29-35. Number. Unit: percentage of subjects

Measure	Testosterone 1.25 mL (Applicator) n = 18	Testosterone 2.50 mL (Applicator) n = 18	Testosterone 3.75 mL (Applicator) n = 18
Value	16.7	50.0	77.8

Population analysed: Full Analysis Set (FAS) population was used for this analysis, which comprised of all subjects who had any available Pharmacokinetic (PK) data.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Overall Treatment Period (36 Days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Testosterone 2.50 mL (Hand)	0 of 20 (0%)	0 of 20 (0%)	Not reported
Testosterone 1.25 mL (Applicator)	0 of 20 (0%)	0 of 20 (0%)	Not reported
Testosterone 2.50 mL (Applicator)	0 of 20 (0%)	0 of 20 (0%)	Not reported
Testosterone 3.75 mL (Applicator)	0 of 20 (0%)	1 of 20 (5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypogonadal Males

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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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Testosterone Gel (FE 999303) in people with Hypogonadal Males, run by Ferring Pharmaceuticals at 1 site 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 8 inclusion and 17 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 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator. (time frame: Days 15-21, Days 22-28 & Days 29-35). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01464879.

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 13 Sep 2017.