Male HypogonadismPhase 3SOARNCT02081300
Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism
A Phase 3 study testing Oral testosterone undecanoate, LPCN 1021 and Topical testosterone gel 1.62 % in people with Male Hypogonadism, run by Lipocine Inc..
Trial summary
The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Male Hypogonadism
- What is being tested?
- Oral testosterone undecanoate, LPCN 1021 and Topical testosterone gel 1.62 %
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to May 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).
- Serum total testosterone < 300 ng/dL based on 2 consecutive blood samples
Who cannot join
- A subject will not be eligible for study participation if he meets any of the following criteria.
- History of significant sensitivity or allergy to androgens, castor oil or product excipients.
- Clinically significant findings in the prestudy examinations.
- Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or I-PSS score > 19 points.
- Body mass index (BMI) ≥ 38 kg/m2.
- Clinically significant abnormal laboratory values
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- Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus antibodies (HIV Ab).
- History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
- History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
- History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study drug administration.
- History of stroke or myocardial infarction within the past 5 years.
- History of, or current or suspected, prostate or breast cancer.
- History of diagnosed, severe, untreated, obstructive sleep apnea.
- History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
- History of long QT syndrome or unexplained sudden death in a first degree relative (parent, sibling, or child).
- Concurrent treatment with medications which may impact the absorption, distribution, metabolism or excretion of testosterone undecanoate (TU) or place the subject at risk for treatment with testosterone.
- Subject has a partner who is currently pregnant or planning pregnancy during the course of the clinical trial.
About this study
Official title: Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men
The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.
- Conditions
- Male Hypogonadism
- Being tested
- Oral testosterone undecanoate, LPCN 1021, Topical testosterone gel 1.62 %
- Keywords
- Testosterone, Male hypogonadism, Low testosterone, LPCN 1021, Androgel, Testim, Testopel, Fortesta, Axiron., Hypogonadism, Eunuchism, Gonadal Disorders, Endocrine System Diseases, Testosterone enanthate, Testosterone undecanoate, Testosterone 17 beta-cypionate, Methyltestosterone, Androgens, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists
- Medical subject headings
- Eunuchism, Hypogonadism, Gonadal Disorders, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral testosterone undecanoate, LPCN 1021Drug
Topical testosterone gel 1.62 %Drug
| Study group | Role | What they receive |
|---|---|---|
| Oral testosterone undecanoate, LPCN 1021 | Experimental | Oral testosterone undecanoate: Initial dose: 225 mg TU BID. Dose titrated up to 300 mg TU BID or down to 150 mg TU BID based on serum T at Week 3 and 7. Receives: Drug: Oral testosterone undecanoate, LPCN 1021 |
| Topical testosterone gel 1.62 % | Other | Topical testosterone gel 1.62%: Initial dose: 40.5 mg T once daily. Dose titrated down to 20.25 mg or up to 81 mg based on serum T on Days 14 and 28 Receives: Drug: Topical testosterone gel 1.62 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of LPCN 1021-treated subjects who achieve a total testosterone concentration [Cavg] between 300 - 1140 ng/dL.
Measured: Following 13 weeks of treatment
Secondary outcomes (4)
Percentage of LPCN 1021-treated subjects with maximum serum T concentrations (Cmax) values that are (a) less than 1500 ng/dL; (b) between 1800 and 2500 ng/dL, and (c) greater than 2500 ng/dL
Measured: Following 13 weeks of treatment
Change from baseline in patient reported outcomes for LPCN 1021 (i.e., International Prostate Symptom Score [I-PSS], Psychosexual Daily Questionnaire [PDQ], Short Form-36 Questionnaire [SF-36])
Measured: 52 weeks
Change from baseline to 52 weeks in safety laboratory parameters (i.e., clinical chemistry, hematology, PSA)
Measured: 52 weeks
Number of subjects with adverse events during 52 weeks of treatment
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lipocine Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health, PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- Anthony DelConte, MD, Study director, Chief Medical Director, Lipocine, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081300
- Sponsor's protocol ID
- LPCN 1021-13-001
- Acronym
- SOAR
- Status last verified
- Oct 2017
- First submitted
- 20 Feb 2014
- Last updated
- 23 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Miner M, Wang C, Kaminetsky J, Khera M, Goldstein I, Carson C 3rd, Chidambaram N, King S, Dobs A. Safety, efficacy, and pharmacokinetics of oral testosterone undecanoate in males with hypogonadism. Andrology. 2025 May;13(4):882-893. doi: 10.1111/andr.13747. Epub 2024 Sep 10.
PubMed 39252657
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men
- ClinicalTrials.gov ID
- NCT02081300
- Acronym / sponsor ID
- SOAR / LPCN 1021-13-001
- Conditions
- Male Hypogonadism
- Keywords
- Testosterone, Male hypogonadism, Low testosterone, LPCN 1021, Androgel, Testim, Testopel, Fortesta
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Lipocine Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health, PPD Development, LP
- Study start
- Feb 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Not posted in the source record
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 this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.
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, LPCN 1021 | Experimental | Drug: Oral testosterone undecanoate, LPCN 1021Oral testosterone undecanoate: Initial dose: 225 mg TU BID. Dose titrated up to 300 mg TU BID or down to 150 mg TU BID based on serum T at Week 3 and 7. |
| Topical testosterone gel 1.62 % | Other | Drug: Topical testosterone gel 1.62 %Topical testosterone gel 1.62%: Initial dose: 40.5 mg T once daily. Dose titrated down to 20.25 mg or up to 81 mg based on serum T on Days 14 and 28 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).
- Serum total testosterone < 300 ng/dL based on 2 consecutive blood samples
Key exclusion criteria (17 listed)
- A subject will not be eligible for study participation if he meets any of the following criteria.
- History of significant sensitivity or allergy to androgens, castor oil or product excipients.
- Clinically significant findings in the prestudy examinations.
- Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or I-PSS score > 19 points.
- Body mass index (BMI) ≥ 38 kg/m2.
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, LPCN 1021 | Drug | Oral testosterone undecanoate, LPCN 1021 |
| Topical testosterone gel 1.62 % | Drug | Topical testosterone gel 1.62 % |
Primary outcome
Proportion of LPCN 1021-treated subjects who achieve a total testosterone concentration [Cavg] between 300 - 1140 ng/dL.
Time frame: Following 13 weeks of treatment
4 secondary outcomes
Percentage of LPCN 1021-treated subjects with maximum serum T concentrations (Cmax) values that are (a) less than 1500 ng/dL; (b) between 1800 and 2500 ng/dL, and (c) greater than 2500 ng/dL
Time frame: Following 13 weeks of treatment
Change from baseline in patient reported outcomes for LPCN 1021 (i.e., International Prostate Symptom Score [I-PSS], Psychosexual Daily Questionnaire [PDQ], Short Form-36 Questionnaire [SF-36])
Time frame: 52 weeks
Change from baseline to 52 weeks in safety laboratory parameters (i.e., clinical chemistry, hematology, PSA)
Time frame: 52 weeks
Number of subjects with adverse events during 52 weeks of treatment
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2017.
- Derived from this study: PubMed 39252657Miner M, Wang C, Kaminetsky J, Khera M, Goldstein I, Carson C 3rd, Chidambaram N, King S, Dobs A. Safety, efficacy, and pharmacokinetics of oral testosterone undecanoate in males with hypogonadism. Andrology. 2025 May;13(4):882-893. doi: 10.1111/andr.13747. Epub 2024 Sep 10.
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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.
Anthony DelConte, MD study director
Chief Medical Director, Lipocine, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral testosterone undecanoate, LPCN 1021 and Topical testosterone gel 1.62 % in people with Male Hypogonadism, run by Lipocine Inc..
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 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 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of LPCN 1021-treated subjects who achieve a total testosterone concentration [Cavg] between 300 - 1140 ng/dL. (time frame: Following 13 weeks of treatment). 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 NCT02081300, 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 23 Oct 2017.