Male HypogonadismPhase 2NCT00924612

Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation

A Phase 2 study testing Oral testosterone undecanoate (containing 300 mg T) in people with Male Hypogonadism, run by Clarus Therapeutics, Inc. at 2 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation. 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?: Oral testosterone undecanoate (containing 300 mg T)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 2 sitesin 2 countries
Study dates: Jul 2009to Jul 2010
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 65 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Male
Age 18-65
Morning serum testosterone (T) <300 ng/dL on two occasions

Who cannot join

Significant intercurrent disease
Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score >15 or history of prostate cancer.
Serum transaminases >2 times upper limit of normal
Serum bilirubin >2.0 mg/dL
Hematocrit <35% or >50%
BMI >36
Untreated, obstructive sleep apnea.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

LABiomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90502

Other trials in United States

Canada1 site

Anapharm, Inc.
Québec, Quebec, G1P 0A2

Other trials in Canada

About this study

Official title: Phase II Study of the Effect of Food With Various Levels of Fat on the Pharmacokinetics of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men

The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.

Read the detailed description

Pharmacokinetics will be evaluated after the following types of meals: very low fat, low fat, normal diet, high fat, and fasting. Subjects will have one dose of TU administered 30 minutes after the initiation of the meal.

Conditions: Male Hypogonadism
Being tested: Oral testosterone undecanoate (containing 300 mg T)
Keywords: Primary hypogonadism, Secondary 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.

Oral testosterone undecanoate (containing 300 mg T)Drug

Study groups in NCT00924612
Study group	Role	What they receive
Fasting (Treatment A)	Experimental	Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state Receives: Drug: Oral testosterone undecanoate (containing 300 mg T)
Very low fat diet (Treatment B)	Experimental	Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with very low fat (6-10% fat). Receives: Drug: Oral testosterone undecanoate (containing 300 mg T)
Low fat diet (Treatment C)	Experimental	Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with low fat (20% fat). Receives: Drug: Oral testosterone undecanoate (containing 300 mg T)
Normal diet (Treatment D)	Experimental	Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with normal fat (30% fat). Receives: Drug: Oral testosterone undecanoate (containing 300 mg T)
High fat diet (Treatment E)	Experimental	Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with high fat (50% fat). Receives: Drug: Oral testosterone undecanoate (containing 300 mg T)

What is being measured

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

Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet
PK population where subjects are randomly assigned to one of four dietary sequences of five fat regimens. Active drug is identical for all subjects and all diets. Effect of normal dietary fat is compared to fasting, very low fat, low fat, and high fat diets for mean T Cavg25.
Measured: 25 hour serial blood draws separated by 4 to 10 days of washout between treatments.

Timeline

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

Jul 2009Jul 2010

First posted19 Jun 2009 (estimated)
Study startJul 2009
Primary completionSep 2009
Study completionJul 2010

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Open-label, five-period, randomized, four-sequence (ABCDE, BDCEA,CBEDA, DBAEC), cross-over study to determine the effect of food containing various amounts of dietary fat on the pharmacokinetics of oral TU.
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00924612
Sponsor's protocol ID: CLAR-09008
Status last verified: Nov 2020
First submitted: 17 Jun 2009
Last updated: 2 Dec 2020
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

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 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study of the Effect of Food With Various Levels of Fat on the Pharmacokinetics of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men
ClinicalTrials.gov ID: NCT00924612
Acronym / sponsor ID: CLAR-09008
Conditions: Male Hypogonadism
Keywords: Primary hypogonadism, Secondary hypogonadism
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Clarus Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Sep 2009 (actual)
Study completion: Jul 2010 (actual)
First posted: 19 Jun 2009 (estimated)
Results: Posted 2 Dec 2020

Clinical summary

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

The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5
Model description: Open-label, five-period, randomized, four-sequence (ABCDE, BDCEA,CBEDA, DBAEC), cross-over study to determine the effect of food containing various amounts of dietary fat on the pharmacokinetics of oral TU.

Arm	Type	Receives
Fasting (Treatment A)	Experimental	Drug: Oral testosterone undecanoate (containing 300 mg T)Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state
Very low fat diet (Treatment B)	Experimental	Drug: Oral testosterone undecanoate (containing 300 mg T)Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with very low fat (6-10% fat).
Low fat diet (Treatment C)	Experimental	Drug: Oral testosterone undecanoate (containing 300 mg T)Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with low fat (20% fat).
Normal diet (Treatment D)	Experimental	Drug: Oral testosterone undecanoate (containing 300 mg T)Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with normal fat (30% fat).
High fat diet (Treatment E)	Experimental	Drug: Oral testosterone undecanoate (containing 300 mg T)Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with high fat (50% fat).

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male
Age 18-65
Morning serum testosterone (T) <300 ng/dL on two occasions

Key exclusion criteria (7 listed)

Significant intercurrent disease
Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score >15 or history of prostate cancer.
Serum transaminases >2 times upper limit of normal
Serum bilirubin >2.0 mg/dL
Hematocrit <35% or >50%

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 undecanoate (containing 300 mg T)	Drug	Fasting (Treatment A), High fat diet (Treatment E), Low fat diet (Treatment C), Normal diet (Treatment D), Very low fat diet (Treatment B)

Primary outcome

Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet
Time frame: 25 hour serial blood draws separated by 4 to 10 days of washout between treatments.
PK population where subjects are randomly assigned to one of four dietary sequences of five fat regimens. Active drug is identical for all subjects and all diets. Effect of normal dietary fat is compared to fasting, very low fat, low fat, and high fat diets for mean T Cavg25.

Results and safety

Results posted to the registry on 2 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence ABCDE	4	4
Sequence BDCEA	4	4
Sequence CBEDA	4	4
Sequence DBAEC	4	4

Primary outcome: Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet

Time frame: 25 hour serial blood draws separated by 4 to 10 days of washout between treatments.. Geometric mean (Standard Deviation). Unit: ng/dL

Measure	Fasting n = 16	Very Low Fat Diet n = 16	Low Fat Diet n = 16	Normal Diet n = 16	High Fat Diet n = 16
Value	6.38 (0.456)	6.73 (0.410)	6.88 (0.356)	7.00 (0.264)	7.18 (0.312)

Normal Diet vs High Fat Diet: Odds Ratio, log: 130.83 (90% CI 113.59 to 150.70), p = 0.0025, t-test, 2 sided
Low Fat Diet vs Normal Diet: Odds Ratio, log: 101.84 (90% CI 86.80 to 119.47), p = 0.8494, t-test, 2 sided
Very Low Fat Diet vs Normal Diet: Odds Ratio, log: 73.55 (90% CI 63.23 to 85.55), p = 0.0013, t-test, 2 sided

Population analysed: PK population

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fasting	0 of 16 (0%)	2 of 16 (12.5%)	0 of 16
Very Low Fat Diet	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Low Fat Diet	0 of 16 (0%)	2 of 16 (12.5%)	0 of 16
Normal Diet	0 of 16 (0%)	4 of 16 (25%)	0 of 16
High Fat Diet	0 of 16 (0%)	3 of 16 (18.8%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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
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

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

LABiomedical Research Institute at Harbor-UCLA Medical Center

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oral testosterone undecanoate (containing 300 mg T) in people with Male Hypogonadism, run by Clarus Therapeutics, Inc. at 2 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 3 inclusion and 7 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 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 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 2 Dec 2020). 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?

Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet (time frame: 25 hour serial blood draws separated by 4 to 10 days of washout between treatments.). 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 NCT00924612.

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 2 Dec 2020.