Recruiting
Phase 3

Testosterone Cypionate

Sponsor:

Amneal Pharmaceuticals, LLC

Code:

NCT07898072

Conditions

Male Hypogonadism

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Testosterone Cypionate 75 mg

Testosterone cypionate 50 mg

Testosterone cypionate 100 mg

Study Details

Brief 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. 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.

Conditions

Male Hypogonadism

Study ID

NCT07898072

Start date

Sep 28, 2026

Status verified date

Oct, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

190 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Testosterone Cypionate Auto-Injector (75 mg)

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.

experimental: Testosterone Cypionate Auto-Injector (50 mg)

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.

experimental: Testosterone Cypionate Auto-Injector (100 mg)

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.

Interventions

Testosterone Cypionate 75 mg

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 mg

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 mg

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.

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) ]

Central Contacts and Locations

Central contacts

Janie M Gwinn, Ph.D.

+1-631-310-7392Janie.Gwinn@amneal.com

Locations

Floridian Clinical Research LLC (Site ID 101)

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

William Sanchez, Doctor

305-330-9977

Quality Research Center (Site ID 104)

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Ariana Bauer, Doctor

402-934-0044

AccuMed Research Associates (Site ID 106)

Recruiting

Garden City, New York, United States, 11530

Contacts

Mitchell Efros, Doctor

516-746-2190

Biobehavioral Research Center of Austin (Austin TX) (Site ID 105)

Recruiting

Austin, Texas, United States, 78759

Contacts

Mark Hutchens, Doctor

512-382-6661

More Information

Sponsor

Amneal Pharmaceuticals, LLC

Last update posted

Oct 27, 2026

Last verified

Oct, 2026

Keywords

  • Testosterone Replacement Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-28. This information was provided to ClinicalTrials.gov by Amneal Pharmaceuticals, LLC on 2026-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.