Male HypogonadismPhase 3NCT01699178

Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men

A Phase 3 study testing Oral testosterone undecanoate and Transdermal testosterone gel (AndroGel) in people with Male Hypogonadism, run by Clarus Therapeutics, Inc. at 30 sites in 2 countries.

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

The purpose of this one year extension (follow-up) study is to gather additional safety data in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III study CLAR-09007. Read more about this study

Who is it for?: Ages 18 to 75 years, men only
Conditions the study is for: Male Hypogonadism
What is being tested?: Oral testosterone undecanoate and Transdermal testosterone gel (AndroGel)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 182 participants
Where: 30 sitesin 2 countries
Study dates: Aug 2012to Apr 2014
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

Subjects were to have completed Study CLAR-09007.
Subjects were to have adequate venous access in the left or right arm to allow collection of a number of blood samples via a venous cannula.
Subjects were required to remain off all forms of T except for study medication throughout the entire study.
Subjects voluntarily gave written informed consent to participate in this study.
Subjects meeting any of the following criteria were not eligible for participation in this study:
Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease, or psychiatric illness developed during the Phase III study that would, in the opinion of the Investigator, require exclusion from this study.

Show all 13Show fewer

Untreated, severe obstructive sleep apnea (diagnosed during previous Phase III study).
Serum transaminases >2 times upper limit of normal (ULN), serum bilirubin >2.0 mg/dL and serum creatinine >2.0 mg/dL at the final visit for Study CLAR 09007.
Abnormal prostate digital rectal examination (palpable nodule[s]) or elevated PSA (serum PSA >4 ng/mL) at the final visit for Study CLAR-09007.
Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum T, such as androstenedione or dehydroepiandrosterone (DHEA).
Known malabsorption syndrome and/or current treatment with oral lipase inhibitors (e.g., orlistat [Xenical]) and bile acid-binding resins (e.g., cholestyramine [Questran], colestipol [Colestid]).
Poor compliers with study medication, study procedures, or study visits in Study CLAR 09007.
Concomitant use of antiandrogens, estrogens, potent oral CYP3A4 inducers (e.g., barbiturates, glucocorticoids [pharmacologic doses of glucocorticoids for replacement therapy were not exclusionary]) and potent CYP3A4 inhibitors (e.g., human immunodeficiency virus [HIV] antivirals [indinavir, nelfinavir, ritonavir, saquinavir, delaviridine], amiodarone, azithromycin, ciprofloxacin, ketoconazole). (Note: Short-term ciprofloxacin administration completed more than 7 days prior to study visits was not exclusionary during the study.)

Who cannot join

None listed.

Trial locations and contacts

30 sites in 2 countries.

Country

City, postcode or hospital

30 sites in 2 countries

United States25 sites

South Florida Medical Research
Aventura, Florida, 33180
Urologic Consultants of Southeast Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004
Johns Hopkins University
Baltimore, Maryland, 21287
Alabama Clinical Therapeutics, Inc.
Birmingham, Alabama, 35235
Alabama Internal Medicine, PC
Birmingham, Alabama, 35235
Boston University School of Medicine
Boston, Massachusetts, 02118
Maimonides Medical Center
Brooklyn, New York, 11235
Providence Clinical Research
Burbank, California, 91505
Alabama Clinical Therapeutics
Calera, Alabama, 35040
Research Across America
Carrollton, Texas, 75010
Research Across America
Dallas, Texas, 75234
Bruce R. Gilbert, MD, PhD
Great Neck, New York, 11021
Medical Affiliated Research Center, Inc
Huntsville, Alabama, 35801
South Orange County Endocrinology
Laguna Hills, California, 92653
Tower Urology
Los Angeles, California, 90048
David Geffen School of Medicine, UCLA
Los Angeles, California, 90095
University of Louisville
Louisville, Kentucky, 40202
Sunstone Medical Research
Medford, Oregon, 97504
Connecticut Clinical Research Center/ConnecTrials
Middlebury, Connecticut, 06762
University of CT School of Medicine
New Haven, Connecticut, 06511
University Urology Associates
New York, New York, 10016
Michael A. Werner
Purchase, New York, 10577
University of Washington
Seattle, Washington, 98195
Harbor-UCLA Medical Center, LA Biomedical Research Institute
Torrance, California, 90502
Quality of Life Medical and Research Centers, LLC
Tucson, Arizona, 85712

Other trials in United States

Germany5 sites

University of Bonn, Clinic for Dermatology and Allergy
Bonn, 53105
University of Halle, Center for Reproduction and Andrology
Halle, 06120
Praxis Dr. Szymula
Leipzig, 04105
Praxis Dr. Schulze
Markkleeberg, 04416
University of Muenster, Center for Reproduction and Andrology
Münster, 48149

Other trials in Germany

About this study

Official title: Open-Label Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Read the detailed description

This is the long-term extension of Study CLAR-09007, which like Study CLAR-09007, is an open-label study. This study contained an arm to evaluate the oral TU formulation as well as a comparator arm of the market-leading transdermal T-gel formulation. The comparator arm was included in the Phase III study and in this extension study to allow a general evaluation of comparative safety. Subjects randomized to oral TU in the Phase III study were continued on oral TU in the extension, and those who completed this 12-month Phase IV study have been followed for a total of 2 years of oral TU therapy. Likewise, subjects randomized to transdermal T-gel in the Phase III study were continued on T-gel in the extension, and those who completed this 12-month Phase IV study have been followed for a total of 2 years of T gel therapy. This 2-year period of therapy and assessments was to provide a long-term view of the safety of oral TU and the stability of the T replacement.

Conditions: Male Hypogonadism
Being tested: Oral testosterone undecanoate, Transdermal testosterone gel (AndroGel)
Medical subject headings: Eunuchism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral testosterone undecanoateDrug
Also called Oral TU
Total daily dose of T = 200 mg T (as 316 mg TU) to 600 mg T (as 948 mg TU), taken as 100 mg to 300 mg T BID
Transdermal testosterone gel (AndroGel)Drug
Also called AndroGel
Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD

Study groups in NCT01699178
Study group	Role	What they receive
Oral testosterone undecanoate	Experimental	Oral testosterone undecanoate; continue dose from previous Phase III trial; 100-300 mg T (as TU), BID, for 12 months. Receives: Drug: Oral testosterone undecanoate
Transdermal testosterone gel (AndroGel)	Active comparator	Transdermal testosterone gel; continue dose from previous Phase III trial, 2.5-10 g/applied once daily for 12 months Receives: Drug: Transdermal testosterone gel (AndroGel)

What is being measured

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

Absolute Change From Baseline in T Cholesterol
Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Measured: Approximately 365 days
Absolute Change From Baseline in HDL
Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Measured: Approximately 365 days
Absolute Change From Baseline in LDL
Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Measured: Approximately 365 days
Absolute Change From Baseline in Hgb
Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Measured: Approximately 365 days
Absolute Change From Baseline in Hct
Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Measured: Approximately 365 days
Absolute Change From Baseline in Prostate Volume
Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Measured: Approximately 365 days

Timeline

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

Aug 2012Apr 2014

First posted3 Oct 2012 (estimated)
Study startAug 2012
Primary completionApr 2014
Study completionApr 2014

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.
Publications (1)Papers the sponsor has linked to this study.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 182 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01699178
Sponsor's protocol ID: CLAR-12010
Status last verified: Jun 2021
First submitted: 5 Sep 2012
Last updated: 28 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Individual Participant data shared with associated investigational sites only.

Publications

Honig S, Gittelman M, Kaminetsky J, Wang C, Amory JK, Rohowsky N, Dudley RE, Woun Seo B, Newmark J, Swerdloff R. Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety. J Sex Med. 2022 Dec;19(12):1750-1758. doi: 10.1016/j.jsxm.2022.09.002. Epub 2022 Oct 20.
PubMed 36272969

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

RecruitingObservational study
Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism
Hypogonadism, Male, Endocrine Disease
RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Hypogonadism, Male
RecruitingPhase 4
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Prostate Cancer, Hypogonadism, Male
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
Not yet recruitingObservational study
Hematological Profile in Children With Numerical Chromosomal Disorders
Down Syndrome, Turner Syndrome

All Male Hypogonadism trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-Label Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
ClinicalTrials.gov ID: NCT01699178
Acronym / sponsor ID: CLAR-12010
Conditions: Male Hypogonadism
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 182 participants (actual)
Lead sponsor: Clarus Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 3 Oct 2012 (estimated)
Results: Posted 30 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Oral testosterone undecanoate	Experimental	Drug: Oral testosterone undecanoateOral testosterone undecanoate; continue dose from previous Phase III trial; 100-300 mg T (as TU), BID, for 12 months.
Transdermal testosterone gel (AndroGel)	Active comparator	Drug: Transdermal testosterone gel (AndroGel)Transdermal testosterone gel; continue dose from previous Phase III trial, 2.5-10 g/applied once daily for 12 months

Who may qualify

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

Key inclusion criteria (13 listed)

Subjects were to have completed Study CLAR-09007.
Subjects were to have adequate venous access in the left or right arm to allow collection of a number of blood samples via a venous cannula.
Subjects were required to remain off all forms of T except for study medication throughout the entire study.
Subjects voluntarily gave written informed consent to participate in this study.
Subjects meeting any of the following criteria were not eligible for participation in this study:

Key exclusion criteria (0 listed)

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
Oral testosterone undecanoateAlso: Oral TUTotal daily dose of T = 200 mg T (as 316 mg TU) to 600 mg T (as 948 mg TU), taken as 100 mg to 300 mg T BID	Drug	Oral testosterone undecanoate
Transdermal testosterone gel (AndroGel)Also: AndroGelTotal daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD	Drug	Transdermal testosterone gel (AndroGel)

Primary outcome

Absolute Change From Baseline in T Cholesterol
Time frame: Approximately 365 days
Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Absolute Change From Baseline in HDL
Time frame: Approximately 365 days
Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Absolute Change From Baseline in LDL
Time frame: Approximately 365 days
Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Absolute Change From Baseline in Hgb
Time frame: Approximately 365 days
Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Absolute Change From Baseline in Hct
Time frame: Approximately 365 days
Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Absolute Change From Baseline in Prostate Volume
Time frame: Approximately 365 days
Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.

Results and safety

Results posted to the registry on 30 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oral Testosterone Undecanoate	88	69
Transdermal Testosterone Gel (AndroGel)	94	62

Primary outcome: Absolute Change From Baseline in T Cholesterol

Time frame: Approximately 365 days. Mean (95% Confidence Interval). Unit: mg/dL

Measure	Oral TU n = 68	Transdermal T-gel n = 62
Value	0.2 (-8.4 to 8.9)	8.2 (-0.1 to 16.6)

Population analysed: The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.

Primary outcome: Absolute Change From Baseline in HDL

Time frame: Approximately 365 days. Mean (95% Confidence Interval). Unit: mg/dL

Measure	Oral TU n = 68	Transdermal T-gel n = 62
Value	2.4 (0.7 to 4.1)	4.0 (2.5 to 5.5)

Population analysed: The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.

Primary outcome: Absolute Change From Baseline in LDL

Time frame: Approximately 365 days. Mean (95% Confidence Interval). Unit: mg/dL

Measure	Oral TU n = 67	Transdermal T-gel n = 61
Value	-1.5 (-9.5 to 6.5)	6.0 (-1.2 to 13.1)

Population analysed: The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.

Primary outcome: Absolute Change From Baseline in Hgb

Time frame: Approximately 365 days. Mean (95% Confidence Interval). Unit: g/dL

Measure	Oral TU n = 68	Transdermal T-gel n = 62
Value	0.36 (0.11 to 0.61)	0.36 (0.07 to 0.65)

Population analysed: The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.

Adverse events

Time frame: 365 days. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oral TU	6 of 88 (6.8%)	32 of 88 (36.4%)	0 of 88
Transdermal T-gel	6 of 94 (6.4%)	33 of 94 (35.1%)	0 of 94

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36272969Honig S, Gittelman M, Kaminetsky J, Wang C, Amory JK, Rohowsky N, Dudley RE, Woun Seo B, Newmark J, Swerdloff R. Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety. J Sex Med. 2022 Dec;19(12):1750-1758. doi: 10.1016/j.jsxm.2022.09.002. Epub 2022 Oct 20.
Individual participant dataSharing planned: No. Individual Participant data shared with associated investigational sites only.

Related trials for Male Hypogonadism

RecruitingObservational study
Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism
Hypogonadism, Male, Endocrine Disease
RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Hypogonadism, Male
RecruitingPhase 4
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Prostate Cancer, Hypogonadism, Male
RecruitingObservational study
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Not yet recruitingObservational study
Hematological Profile in Children With Numerical Chromosomal Disorders
Down Syndrome, Turner Syndrome

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.

Ronald Swerdloff, MD principal investigator

University of California, Los Angeles

30 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 Oral testosterone undecanoate and Transdermal testosterone gel (AndroGel) in people with Male Hypogonadism, run by Clarus Therapeutics, Inc. at 30 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 13 inclusion and 0 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 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Germany. 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 30 Oct 2018). 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?

Absolute Change From Baseline in T Cholesterol (time frame: Approximately 365 days). The study lists 6 primary outcomes in all. 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 NCT01699178, which also lists 1 linked publication.

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 28 Jun 2021.