Male HypogonadismPhase 3NCT07898072
Safety and Efficacy of Weekly Testosterone Cypionate Auto-Injector in Men With Hypogonadism
A Phase 3 study testing Testosterone Cypionate 75 mg, Testosterone cypionate 50 mg and Testosterone cypionate 100 mg in people with Male Hypogonadism, run by Amneal Pharmaceuticals, LLC at 10 sites in United States.
Trial summary
The goal of this Phase 3 clinical trial is to evaluate the safety, efficacy, and usability of a weekly subcutaneous testosterone cypionate auto-injector in adult males with hypogonadism. 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?
- Testosterone Cypionate 75 mg, Testosterone cypionate 50 mg and Testosterone cypionate 100 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 10 sitesUnited States
- Study dates
- 28 Sep 2026to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Adults assigned male at birth, aged 18 to 75 years.
- Documented diagnosis of hypogonadism (low testosterone) with at least one associated symptom, such as reduced sexual desire, erectile dysfunction, fatigue, reduced energy, loss of muscle mass, decreased body hair, or mood changes.
- Fasting morning serum total testosterone concentration below 300 ng/dL on two separate occasions, at least 72 hours apart, during screening. One additional test may be allowed if one of the initial measurements is 300 ng/dL or higher.
- Body mass index (BMI) between 18.5 and 39.9 kg/m².
- Prostate-specific antigen (PSA) level between 0 and 2.5 ng/mL for participants aged 50 years or younger, or between 0 and 4.0 ng/mL for participants older than 50 years.
- Willingness to use effective contraception throughout the study and for 30 days after the last dose of study medication.
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- Low-density lipoprotein (LDL) cholesterol below 190 mg/dL.
- Hemoglobin level of 16 g/dL or lower for participants without previous testosterone replacement therapy, or 17 g/dL or lower for participants who received testosterone replacement therapy within 30 days before screening.
- Participants with diabetes must have been on a stable antidiabetic treatment regimen for at least 4 weeks before screening and have HbA1c of 9.0% or lower, or have diabetes considered adequately controlled by the investigator.
- Participants with high cholesterol or other lipid disorders must have been on stable lipid-lowering treatment for at least 4 weeks before screening or have their condition considered adequately controlled by the investigator.
- Participants with high blood pressure must have been on stable antihypertensive treatment for at least 1 month before screening or have blood pressure considered adequately controlled by the investigator. Participants with normal blood pressure who are not receiving antihypertensive treatment are also eligible.
- Participants previously receiving testosterone replacement therapy must complete the required washout period before qualifying testosterone measurements: generally 2 weeks for oral, buccal, or transdermal treatment as specified in the protocol; 5 weeks for intramuscular testosterone; or the required interval following testosterone implants.
- Adequate venous access for collection of multiple blood samples.
- Willing and able to provide written informed consent and comply with all study procedures, treatment requirements, and scheduled visits.
Who cannot join
- Known allergy, hypersensitivity, or unusual reaction to testosterone products or cottonseed oil.
- Current opioid use, subject to the protocol's specific medication restrictions.
- Two serum total testosterone measurements below 100 ng/dL during screening.
- Hematocrit of 52% or higher at the initial screening visit.
- Current or previous prostate cancer.
- Any cancer diagnosed or treated within the previous 5 years, except non-melanoma skin cancer.
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- A prostate nodule or abnormal hardening detected during digital rectal examination.
- Significant urinary obstruction due to prostate disease or severe lower urinary tract symptoms, including an International Prostate Symptom Score (I-PSS) greater than 19.
- Severe congestive heart failure classified as New York Heart Association Class III or IV.
- Heart attack, stroke, transient ischemic attack, unstable angina requiring hospitalization, coronary angioplasty, coronary bypass surgery, uncontrolled cardiac arrhythmia, carotid artery procedure, or major peripheral vascular procedure within 6 months before screening.
- Clinically significant electrocardiogram (ECG) abnormality, history of long QT syndrome, or unexplained sudden death in a first-degree relative.
- History of or current treatment for blood clots or conditions associated with increased blood clotting, including deep vein thrombosis, pulmonary embolism, or known thrombophilia. Low-dose aspirin (81 mg) is permitted.
- Untreated sleep apnea.
- History of polycythemia vera or secondary polycythemia (an abnormally high red blood cell count).
- Clinically significant cardiovascular, kidney, liver, blood, psychiatric, neurological, endocrine, gastrointestinal, or respiratory disorder that could interfere with study participation or place the participant at increased risk, as determined by the investigator.
- Endocrine disorders requiring treatment other than hypogonadism, unless replacement medication has been stable for at least 3 months before study entry.
- Severe kidney impairment, defined as estimated glomerular filtration rate (eGFR) below 30 mL/min.
- Liver enzyme levels (ALT or AST) greater than three times the upper limit of normal.
- Positive screening test for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibody.
- History of drug or alcohol abuse within the previous 2 years that could interfere with study participation or evaluation, as determined by the investigator.
- Positive drug screening test without an appropriate documented prescription and medical indication, except where the protocol permits tetrahydrocannabinol (THC) use under applicable state law.
- Clinically significant tobacco or cigarette use within the previous 2 years, as determined by the investigator. Light smokers (5 or fewer cigarettes daily) may participate.
- Active suicidal thoughts involving a method, intent, or plan within the previous 6 months.
- Suicide attempt within the previous 12 months.
- New or worsening depression, anxiety, or suicidal thoughts within the previous 6 months, as specified in the protocol.
- Skin conditions at the intended injection site that could interfere with assessment of injection site reactions, including significant scarring, tattoos, eczema, psoriasis, urticaria, or other skin disorders.
- Tattoo removal near the intended injection site within 6 months before screening.
- Recent or current use of medications affecting testosterone concentrations or androgen activity, including finasteride, dutasteride, spironolactone, flutamide, bicalutamide, ketoconazole, anabolic steroids, or similar medications, without the required washout period.
- Use of over-the-counter products, herbal preparations, or dietary supplements known to affect testosterone levels within 7 days before study entry.
- Use of clomiphene, enclomiphene, or androgenic steroid derivatives within 6 months before screening.
- Use of anti-estrogen treatment within 90 days before screening.
- Use of estrogen, gonadotropin-releasing hormone agonists, growth hormone, or anti-androgen treatment within 12 months before screening.
- Use of dehydroepiandrosterone (DHEA), other androgens, anabolic steroids, sex hormones, or supplements affecting testosterone pharmacokinetics without completing the protocol-required washout period. DHEA requires at least 4 weeks of washout.
- Use of systemic adrenocorticotropic hormone or prohibited oral or injectable depot corticosteroids. Inhaled corticosteroids for respiratory conditions are permitted.
- Recent use of high-potency opioid medications or systemic glucocorticoids above 7.5 mg/day prednisone equivalent, subject to protocol-specified exceptions.
- Use of long-acting opioid pain medications within 1 month before treatment initiation.
- Concurrent use of medications that could significantly affect testosterone absorption, distribution, metabolism, elimination, or treatment safety.
- Participation in another investigational drug study without completing the required washout period, or use of another investigational drug during this study.
- A sexual partner planning pregnancy during the study.
- Development of gynecomastia (enlargement of male breast tissue) within the previous 6 months.
- Planned major surgical or dental procedure expected to cause blood loss of 500 mL or more during the study.
- Blood or plasma donation within 56 days before screening, or donation of more than 500 mL within the previous 3 months.
- History of poor adherence to medical treatment or concern about reliability in following study requirements, as determined by the investigator.
- Inability to understand the informed consent information in English or another language for which a certified translation is available.
- Any other condition or circumstance that, in the investigator's judgment, makes participation unsuitable or unsafe.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Biobehavioral Research Center of Austin (Austin TX) (Site ID 105)
Austin, Texas, 78759
Mark Hutchens, Doctor, 512-382-6661
Mercedes Livingston
- Not yet recruiting
Accel Research Site Alcanza Clinical Research (Site ID 103)
DeLand, Florida, 32720
Bruce Rankin, Doctor, 386-785-2400
Diana Toney
- Recruiting
AccuMed Research Associates (Site ID 106)
Garden City, New York, 11530
Mitchell Efros, Doctor, 516-746-2190
Leanne Cossu
- Not yet recruiting
Baylor College of Medicine (Site ID 109)
Houston, Texas, 77030
Mohit Khera, Doctor, 713-798-4001
Haarika Gudlavaletti
- Recruiting
Floridian Clinical Research LLC (Site ID 101)
Miami Lakes, Florida, 33016
William Sanchez, Doctor, 305-330-9977
Ric Castaneda
- Not yet recruiting
Integrated Medical Professionals/Advanced Urology Centers of New York (Site ID 107)
New York, New York, 10016
Jed Kaminetsky, Doctor, 212-480-3333
Michael Yang
- Not yet recruiting
Coastal Carolina Research Center (Site ID 102)
North Charleston, South Carolina, 29405
Shannon Conrad, Doctor, 205-757-8212
Mary Love
- Recruiting
Quality Research Center (Site ID 104)
Omaha, Nebraska, 68114
Ariana Bauer, Doctor, 402-934-0044
Tricia Harrison
- Not yet recruiting
Brown University (Site ID 108)
Providence, Rhode Island, 02904
Martin Miner, Doctor, 401-793-4636
Taylor Brauagel
- Not yet recruiting
University of California (UCLA) (Site ID 111)
Santa Monica, California, 90403
Jesse Mills, Doctor, 310-794-770
Dana Levin-Lopez
About this study
Official title: A Single-Blind, Single-Arm, Multiple-Dose Study Evaluating the Safety and Efficacy of Testosterone Cypionate Administered Subcutaneously Via a Weekly Auto-Injector in Adult Males With Hypogonadism Through Week 24
The goal of this Phase 3 clinical trial is to evaluate the safety, efficacy, and usability of a weekly subcutaneous testosterone cypionate auto-injector in adult males with hypogonadism. The main questions it aims to answer are:
- Does weekly testosterone cypionate administered using an auto-injector maintain testosterone levels within the normal range in adult males with hypogonadism?
- What side effects and safety outcomes occur during treatment with testosterone cypionate auto-injector?
- Is the auto-injector easy for participants to use and self-administer?
Read more
All participants will receive testosterone cypionate administered subcutaneously once weekly through an auto-injector. Treatment will begin at a 75 mg weekly dose, with dose adjustments to 50 mg or 100 mg based on testosterone levels measured during the study.
Participants will:
- Receive weekly testosterone cypionate injections using an auto-injector for up to 52 weeks.
- Attend regular clinic visits for physical examinations, laboratory tests, blood pressure monitoring, and safety assessments.
- Provide blood samples to measure testosterone and other hormone levels and evaluate pharmacokinetics.
- Complete questionnaires related to symptoms, quality of life, and ease of use of the auto-injector.
- Record self-administration and treatment compliance in a study diary.
This study will enroll adult males aged 18 to 75 years with hypogonadism and low testosterone concentrations to evaluate treatment through Week 24, with continued safety follow-up through Week 52.
Read the detailed description
Hypogonadism in adult males is characterized by inadequate testosterone production and may be associated with reduced energy, decreased libido, diminished muscle mass and strength, impaired physical function, and other clinical symptoms. Testosterone replacement therapy is commonly used to restore serum testosterone concentrations to the normal physiological range and improve symptoms associated with testosterone deficiency.
This Phase 3, multicenter, single-arm, multiple-dose study is designed to evaluate the long-term efficacy, safety, pharmacokinetic profile, and usability of testosterone cypionate administered subcutaneously via a prefilled weekly auto-injector in adult males with hypogonadism. The study seeks to characterize the ability of the investigational product to achieve and maintain serum testosterone concentrations within the target eugonadal range during chronic administration.
Participants will initiate treatment with a weekly subcutaneous dose of testosterone cypionate administered using the auto-injector. Dose adjustments may be implemented during the study based on serum testosterone concentrations to optimize therapeutic exposure. Pharmacokinetic assessments will be performed to characterize testosterone exposure following repeated dosing and to evaluate maintenance of testosterone concentrations over time.
In addition to evaluating testosterone concentrations, the study will assess the long-term safety and tolerability of weekly subcutaneous testosterone cypionate. Safety evaluations will include monitoring of adverse events, clinical laboratory parameters, vital signs, physical examinations, and other assessments routinely used to evaluate testosterone replacement therapy.
The study will also evaluate participant experience with the auto-injector, including ease of use and successful self-administration. Information obtained from this study is intended to support the clinical evaluation of a convenient, once-weekly subcutaneous testosterone replacement option for adult males with hypogonadism.
This study includes a treatment period and an extension phase to provide additional long-term safety and efficacy data following repeated administration of testosterone cypionate using the auto-injector device.
- Conditions
- Male Hypogonadism
- Being tested
- Testosterone Cypionate 75 mg, Testosterone cypionate 50 mg, Testosterone cypionate 100 mg
- Keywords
- Testosterone Replacement Therapy
- Medical subject headings
- Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone Cypionate 75 mgDrug
Testosterone cypionate injectable solution formulated in cottonseed oil, supplied in a single-use auto-injector containing 75 mg/0.5 mL. The study drug will be administered subcutaneously into the abdomen once weekly. All participants will initiate treatment at 75 mg once weekly, with dose adjustments in 25 mg increments to 50 mg or 100 mg based on serum total testosterone trough concentrations according to protocol-defined criteria. Treatment will continue through the 24-week primary evaluation period, with eligible participants permitted to continue once-weekly treatment through Week 52 for extended safety assessment.
Testosterone cypionate 50 mgDrug
Testosterone cypionate injectable solution formulated in cottonseed oil, supplied in a single-use auto-injector containing 50 mg/0.5 mL. The study drug will be administered subcutaneously into the abdomen once weekly. All participants will initiate treatment at 75 mg once weekly, with dose adjustments in 25 mg increments to 50 mg or 100 mg based on serum total testosterone trough concentrations according to protocol-defined criteria. Treatment will continue through the 24-week primary evaluation period, with eligible participants permitted to continue once-weekly treatment through Week 52 for extended safety assessment.
Testosterone cypionate 100 mgDrug
Testosterone cypionate injectable solution formulated in cottonseed oil, supplied in a single-use auto-injector containing 100 mg/0.5 mL. The study drug will be administered subcutaneously into the abdomen once weekly. All participants will initiate treatment at 75 mg once weekly, with dose adjustments in 25 mg increments to 50 mg or 100 mg based on serum total testosterone trough concentrations according to protocol-defined criteria. Treatment will continue through the 24-week primary evaluation period, with eligible participants permitted to continue once-weekly treatment through Week 52 for extended safety assessment.
| Study group | Role | What they receive |
|---|---|---|
| Testosterone Cypionate Auto-Injector (75 mg) | Experimental | Participants with hypogonadism will receive testosterone cypionate injection administered subcutaneously into the abdomen once weekly using an auto-injector. All participants will initiate treatment at 75 mg once weekly. Receives: Drug: Testosterone Cypionate 75 mg |
| Testosterone Cypionate Auto-Injector (50 mg) | Experimental | Participants with hypogonadism will receive testosterone cypionate injection administered subcutaneously into the abdomen once weekly using an auto-injector. All participants will initiate treatment at 75 mg once weekly. The dose may be adjusted to 50 mg based on serum total testosterone trough concentrations and protocol-defined dose titration criteria. Receives: Drug: Testosterone cypionate 50 mg |
| Testosterone Cypionate Auto-Injector (100 mg) | Experimental | Participants with hypogonadism will receive testosterone cypionate injection administered subcutaneously into the abdomen once weekly using an auto-injector. All participants will initiate treatment at 75 mg once weekly. The dose may be adjusted to100 mg based on serum total testosterone trough concentrations and protocol-defined dose titration criteria. Treatment will continue through the 24-week primary evaluation period. Participants completing Week 24 may continue once-weekly treatment with ongoing safety assessments through Week 52. The first dose will be administered by designated study personnel, followed by participant self-administration as specified in the protocol. Receives: Drug: Testosterone cypionate 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Average Serum Total Testosterone Concentration Within 300-1100 ng/dL at Week 12
The percentage of participants whose average serum total testosterone concentration (Cavg) over the 168-hour (7-day) dosing interval at Week 12 is within the predefined range of 300-1100 ng/dL. Serum total testosterone concentrations will be measured using blood samples collected before and at specified time points after dosing through 168 hours. Cavg will be calculated by dividing the area under the serum concentration-time curve from 0 to 168 hours (AUC0-168h) by 168 hours. The primary efficacy criterion is met if at least 75% of participants achieve the specified range, with the lower bound of the two-sided 95% confidence interval at least 65%. The assessment will be based on the protocol-defined full pharmacokinetic population.
Measured: Week 12 (over the 168-hour dosing interval following the Week 12 dose)
Secondary outcomes (11)
Percentage of Participants With Maximum Serum Total Testosterone Concentration (Cmax) Below 1500 ng/dL at Week 12
The percentage of participants whose maximum serum total testosterone concentration (Cmax) is below 1500 ng/dL during the 168-hour dosing interval at Week 12. Cmax will be determined from serial blood samples collected following the weekly subcutaneous dose. The protocol-defined safety criterion is met if at least 85% of participants have Cmax below 1500 ng/dL.
Measured: Week 12 (0-168 hours after dosing)
Percentage of Participants With Maximum Serum Total Testosterone Concentration (Cmax) Between 1800 and 2500 ng/dL at Week 12
The percentage of participants whose maximum serum total testosterone concentration (Cmax) is between 1800 and 2500 ng/dL, inclusive, during the 168-hour dosing interval at Week 12. Cmax will be determined from serial serum testosterone measurements collected following dosing. The protocol-defined safety criterion is met if fewer than 5% of participants have Cmax within this range.
Measured: Week 12 (0-168 hours after dosing)
Number of Participants With Maximum Serum Total Testosterone Concentration (Cmax) Above 2500 ng/dL at Week 12
The number of participants whose maximum serum total testosterone concentration (Cmax) exceeds 2500 ng/dL during the 168-hour dosing interval at Week 12. Cmax will be determined from serial serum testosterone measurements obtained following dosing. The protocol-defined safety criterion is met if no participants have Cmax above 2500 ng/dL.
Measured: Week 12 (0-168 hours after dosing)
Number and Percentage of Participants With Minimum Serum Total Testosterone Concentration (Cmin) Below 300 ng/dL at Week 12
The number and percentage of participants whose minimum serum total testosterone concentration (Cmin) is below 300 ng/dL during the 168-hour dosing interval at Week 12. Cmin is defined as the lowest observed serum total testosterone concentration during the dosing interval and will be determined using serial pharmacokinetic blood samples.
Measured: Week 12 (0-168 hours after dosing)
Percentage of Participants Receiving 75 mg With Average Serum Total Testosterone Concentration Within 300-1100 ng/dL at Week 12
The percentage of participants receiving the 75 mg testosterone cypionate auto-injector dose whose average serum total testosterone concentration (Cavg0-168h) is within 300-1100 ng/dL at Week 12. Cavg will be calculated as AUC0-168h divided by 168 hours. Participants receiving the 50 mg or 100 mg dose at Week 12 will be excluded from this analysis. The protocol-defined criterion is met if at least 75% of participants achieve the target range, with the lower bound of the 95% confidence interval at least 65%.
Measured: Week 12 (0-168 hours after dosing)
Average Serum Total Testosterone Concentration (Cavg0-168h) in Participants Receiving 100 mg at Week 12
Average serum total testosterone concentration over the 168-hour dosing interval at Week 12 in participants receiving the 100 mg testosterone cypionate auto-injector dose. Cavg will be calculated as AUC0-168h divided by 168 hours and summarized using descriptive statistics, provided sufficient participants receive this dose.
Measured: Week 12 (0-168 hours after dosing)
Average Serum Total Testosterone Concentration (Cavg0-168h) in Participants Receiving 50 mg at Week 12
Average serum total testosterone concentration over the 168-hour dosing interval at Week 12 in participants receiving the 50 mg testosterone cypionate auto-injector dose. Cavg will be calculated as AUC0-168h divided by 168 hours and summarized using descriptive statistics, provided sufficient participants receive this dose.
Measured: Week 12 (0-168 hours after dosing)
Area Under the Serum Total Testosterone Concentration-Time Curve (AUC0-168h) Following the 75 mg Dose at Week 1
The area under the serum total testosterone concentration-time curve from 0 to 168 hours following administration of a single 75 mg subcutaneous dose of testosterone cypionate at Week 1. AUC0-168h represents total serum testosterone exposure over the 7-day dosing interval and will be calculated from serial pharmacokinetic blood samples.
Measured: Week 1 (0-168 hours after the first dose)
Maximum Serum Total Testosterone Concentration (Cmax) Following the 75 mg Dose at Week 1
The maximum observed serum total testosterone concentration following administration of a single 75 mg subcutaneous dose of testosterone cypionate at Week 1. Cmax will be determined from serial pharmacokinetic blood samples collected over the 168-hour dosing interval.
Measured: Week 1 (0-168 hours after the first dose)
Time to Maximum Serum Total Testosterone Concentration (Tmax) Following the 75 mg Dose at Week 1
The time required to reach the maximum observed serum total testosterone concentration following administration of a single 75 mg subcutaneous dose of testosterone cypionate at Week 1. Tmax will be determined from serial pharmacokinetic blood samples collected over the 168-hour dosing interval and expressed in hours.
Measured: Week 1 (0-168 hours after the first dose)
Average Serum Total Testosterone Concentration (Cavg0-168h) Following the 75 mg Dose at Week 1
The average serum total testosterone concentration over the 168-hour dosing interval following administration of a single 75 mg subcutaneous dose of testosterone cypionate at Week 1. Cavg will be calculated by dividing AUC0-168h by 168 hours and expressed in ng/dL.
Measured: Week 1 (0-168 hours after the first dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start28 Sep 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- This is a multicenter, single-arm study in which all participants will receive testosterone cypionate administered subcutaneously once weekly via an autoinjector, starting at a dose of 75 mg. Dose adjustments to 50 mg or 100 mg may be made based on protocol-defined serum total testosterone concentrations. There is no comparator or control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amneal Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avant Sante Research Center S.A. de C.V.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898072
- Sponsor's protocol ID
- AMN-TRT-001
- Other IDs
- AS/CT/CN/ENE-26/002
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind, Single-Arm, Multiple-Dose Study Evaluating the Safety and Efficacy of Testosterone Cypionate Administered Subcutaneously Via a Weekly Auto-Injector in Adult Males With Hypogonadism Through Week 24
- ClinicalTrials.gov ID
- NCT07898072
- Acronym / sponsor ID
- AMN-TRT-001
- Conditions
- Male Hypogonadism
- Keywords
- Testosterone Replacement Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Amneal Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Avant Sante Research Center S.A. de C.V.
- Study start
- 28 Sep 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Oct 2026 (actual)
- 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 goal of this Phase 3 clinical trial is to evaluate the safety, efficacy, and usability of a weekly subcutaneous testosterone cypionate auto-injector in adult males with hypogonadism. The main questions it aims to answer are:
- Does weekly testosterone cypionate administered using an auto-injector maintain testosterone levels within the normal range in adult males with hypogonadism?
- What side effects and safety outcomes occur during treatment with testosterone cypionate auto-injector?
- Is the auto-injector easy for participants to use and self-administer?
All participants will receive testosterone cypionate administered subcutaneously once weekly through an auto-injector. Treatment will begin at a 75 mg weekly dose, with dose adjustments to 50 mg or 100 mg based on testosterone levels measured during the study.
Participants will:
- Receive weekly testosterone cypionate injections using an auto-injector for up to 52 weeks.
- Attend regular clinic visits for physical examinations, laboratory tests, blood pressure monitoring, and safety assessments.
- Provide blood samples to measure testosterone and other hormone levels and evaluate pharmacokinetics.
- Complete questionnaires related to symptoms, quality of life, and ease of use of the auto-injector.
- Record self-administration and treatment compliance in a study diary.
This study will enroll adult males aged 18 to 75 years with hypogonadism and low testosterone concentrations to evaluate treatment through Week 24, with continued safety follow-up through Week 52.
Detailed description
Hypogonadism in adult males is characterized by inadequate testosterone production and may be associated with reduced energy, decreased libido, diminished muscle mass and strength, impaired physical function, and other clinical symptoms. Testosterone replacement therapy is commonly used to restore serum testosterone concentrations to the normal physiological range and improve symptoms associated with testosterone deficiency.
This Phase 3, multicenter, single-arm, multiple-dose study is designed to evaluate the long-term efficacy, safety, pharmacokinetic profile, and usability of testosterone cypionate administered subcutaneously via a prefilled weekly auto-injector in adult males with hypogonadism. The study seeks to characterize the ability of the investigational product to achieve and maintain serum testosterone concentrations within the target eugonadal range during chronic administration.
Participants will initiate treatment with a weekly subcutaneous dose of testosterone cypionate administered using the auto-injector. Dose adjustments may be implemented during the study based on serum testosterone concentrations to optimize therapeutic exposure. Pharmacokinetic assessments will be performed to characterize testosterone exposure following repeated dosing and to evaluate maintenance of testosterone concentrations over time.
In addition to evaluating testosterone concentrations, the study will assess the long-term safety and tolerability of weekly subcutaneous testosterone cypionate. Safety evaluations will include monitoring of adverse events, clinical laboratory parameters, vital signs, physical examinations, and other assessments routinely used to evaluate testosterone replacement therapy.
The study will also evaluate participant experience with the auto-injector, including ease of use and successful self-administration. Information obtained from this study is intended to support the clinical evaluation of a convenient, once-weekly subcutaneous testosterone replacement option for adult males with hypogonadism.
This study includes a treatment period and an extension phase to provide additional long-term safety and efficacy data following repeated administration of testosterone cypionate using the auto-injector device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a multicenter, single-arm study in which all participants will receive testosterone cypionate administered subcutaneously once weekly via an autoinjector, starting at a dose of 75 mg. Dose adjustments to 50 mg or 100 mg may be made based on protocol-defined serum total testosterone concentrations. There is no comparator or control group.
| Arm | Type | Receives |
|---|---|---|
| Testosterone Cypionate Auto-Injector (75 mg) | Experimental | Drug: Testosterone Cypionate 75 mgParticipants with hypogonadism will receive testosterone cypionate injection administered subcutaneously into the abdomen once weekly using an auto-injector. All participants will initiate treatment at 75 mg once weekly. |
| Testosterone Cypionate Auto-Injector (50 mg) | Experimental | Drug: Testosterone cypionate 50 mgParticipants with hypogonadism will receive testosterone cypionate injection administered subcutaneously into the abdomen once weekly using an auto-injector. All participants will initiate treatment at 75 mg once weekly. The dose may be adjusted to 50 mg based on serum total testosterone trough concentrations and protocol-defined dose titration criteria. |
| Testosterone Cypionate Auto-Injector (100 mg) | Experimental | Drug: Testosterone cypionate 100 mgParticipants with hypogonadism will receive testosterone cypionate injection administered subcutaneously into the abdomen once weekly using an auto-injector. All participants will initiate treatment at 75 mg once weekly. The dose may be adjusted to100 mg based on serum total testosterone trough concentrations and protocol-defined dose titration criteria. Treatment will continue through the 24-week primary evaluation period. Participants completing Week 24 may continue once-weekly treatment with ongoing safety assessments through Week 52. The first dose will be administered by designated study personnel, followed by participant self-administration as specified in the protocol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adults assigned male at birth, aged 18 to 75 years.
- Documented diagnosis of hypogonadism (low testosterone) with at least one associated symptom, such as reduced sexual desire, erectile dysfunction, fatigue, reduced energy, loss of muscle mass, decreased body hair, or mood changes.
- Fasting morning serum total testosterone concentration below 300 ng/dL on two separate occasions, at least 72 hours apart, during screening. One additional test may be allowed if one of the initial measurements is 300 ng/dL or higher.
- Body mass index (BMI) between 18.5 and 39.9 kg/m².
- Prostate-specific antigen (PSA) level between 0 and 2.5 ng/mL for participants aged 50 years or younger, or between 0 and 4.0 ng/mL for participants older than 50 years.
Key exclusion criteria (45 listed)
- Known allergy, hypersensitivity, or unusual reaction to testosterone products or cottonseed oil.
- Current opioid use, subject to the protocol's specific medication restrictions.
- Two serum total testosterone measurements below 100 ng/dL during screening.
- Hematocrit of 52% or higher at the initial screening visit.
- Current or previous prostate cancer.
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 Cypionate 75 mgTestosterone cypionate injectable solution formulated in cottonseed oil, supplied in a single-use auto-injector containing 75 mg/0.5 mL. The study drug will be administered subcutaneously into the abdomen once weekly. All participants will initiate treatment at 75 mg once weekly, with dose adjustments in 25 mg increments to 50 mg or 100 mg based on serum total testosterone trough concentrations according to protocol-defined criteria. Treatment will continue through the 24-week primary evaluation period, with eligible participants permitted to continue once-weekly treatment through Week 52 for extended safety assessment. | Drug | Testosterone Cypionate Auto-Injector (75 mg) |
| Testosterone cypionate 50 mgTestosterone cypionate injectable solution formulated in cottonseed oil, supplied in a single-use auto-injector containing 50 mg/0.5 mL. The study drug will be administered subcutaneously into the abdomen once weekly. All participants will initiate treatment at 75 mg once weekly, with dose adjustments in 25 mg increments to 50 mg or 100 mg based on serum total testosterone trough concentrations according to protocol-defined criteria. Treatment will continue through the 24-week primary evaluation period, with eligible participants permitted to continue once-weekly treatment through Week 52 for extended safety assessment. | Drug | Testosterone Cypionate Auto-Injector (50 mg) |
| Testosterone cypionate 100 mgTestosterone cypionate injectable solution formulated in cottonseed oil, supplied in a single-use auto-injector containing 100 mg/0.5 mL. The study drug will be administered subcutaneously into the abdomen once weekly. All participants will initiate treatment at 75 mg once weekly, with dose adjustments in 25 mg increments to 50 mg or 100 mg based on serum total testosterone trough concentrations according to protocol-defined criteria. Treatment will continue through the 24-week primary evaluation period, with eligible participants permitted to continue once-weekly treatment through Week 52 for extended safety assessment. | Drug | Testosterone Cypionate Auto-Injector (100 mg) |
Primary outcome
Percentage of Participants With Average Serum Total Testosterone Concentration Within 300-1100 ng/dL at Week 12
Time frame: Week 12 (over the 168-hour dosing interval following the Week 12 dose)
The percentage of participants whose average serum total testosterone concentration (Cavg) over the 168-hour (7-day) dosing interval at Week 12 is within the predefined range of 300-1100 ng/dL. Serum total testosterone concentrations will be measured using blood samples collected before and at specified time points after dosing through 168 hours. Cavg will be calculated by dividing the area under the serum concentration-time curve from 0 to 168 hours (AUC0-168h) by 168 hours. The primary efficacy criterion is met if at least 75% of participants achieve the specified range, with the lower bound of the two-sided 95% confidence interval at least 65%. The assessment will be based on the protocol-defined full pharmacokinetic population.
11 secondary outcomes
Percentage of Participants With Maximum Serum Total Testosterone Concentration (Cmax) Below 1500 ng/dL at Week 12
Time frame: Week 12 (0-168 hours after dosing)
Percentage of Participants With Maximum Serum Total Testosterone Concentration (Cmax) Between 1800 and 2500 ng/dL at Week 12
Time frame: Week 12 (0-168 hours after dosing)
Number of Participants With Maximum Serum Total Testosterone Concentration (Cmax) Above 2500 ng/dL at Week 12
Time frame: Week 12 (0-168 hours after dosing)
Number and Percentage of Participants With Minimum Serum Total Testosterone Concentration (Cmin) Below 300 ng/dL at Week 12
Time frame: Week 12 (0-168 hours after dosing)
Percentage of Participants Receiving 75 mg With Average Serum Total Testosterone Concentration Within 300-1100 ng/dL at Week 12
Time frame: Week 12 (0-168 hours after dosing)
Average Serum Total Testosterone Concentration (Cavg0-168h) in Participants Receiving 100 mg at Week 12
Time frame: Week 12 (0-168 hours after dosing)
Average Serum Total Testosterone Concentration (Cavg0-168h) in Participants Receiving 50 mg at Week 12
Time frame: Week 12 (0-168 hours after dosing)
Area Under the Serum Total Testosterone Concentration-Time Curve (AUC0-168h) Following the 75 mg Dose at Week 1
Time frame: Week 1 (0-168 hours after the first dose)
Maximum Serum Total Testosterone Concentration (Cmax) Following the 75 mg Dose at Week 1
Time frame: Week 1 (0-168 hours after the first dose)
Time to Maximum Serum Total Testosterone Concentration (Tmax) Following the 75 mg Dose at Week 1
Time frame: Week 1 (0-168 hours after the first dose)
Average Serum Total Testosterone Concentration (Cavg0-168h) Following the 75 mg Dose at Week 1
Time frame: Week 1 (0-168 hours after the first dose)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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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.
10 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 Cypionate 75 mg, Testosterone cypionate 50 mg and Testosterone cypionate 100 mg in people with Male Hypogonadism, run by Amneal Pharmaceuticals, LLC at 10 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 14 inclusion and 45 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janie M Gwinn, Ph.D. (+1-631-310-7392, Janie.Gwinn@amneal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Average Serum Total Testosterone Concentration Within 300-1100 ng/dL at Week 12 (time frame: Week 12 (over the 168-hour dosing interval following the Week 12 dose)). 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 27 Oct 2026.