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
Sponsor study identifier
Secondary identifiers
OTHER · Avant Sante Research Center S.A. de C.V.
interventional
190
1 country
10
Study Start
September 28, 2026
Actual (reported)Primary Completion
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 28, 2026
Actual (reported)October 21, 2026
Actual (reported)October 27, 2026
Actual (reported)March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Week 12 (over the 168-hour dosing interval following the Week 12 dose)
Percentage of Participants With Maximum Serum Total Testosterone Concentration (Cmax) Below 1500 ng/dL at Week 12
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
Week 12 (0-168 hours after dosing)
Number of Participants With Maximum Serum Total Testosterone Concentration (Cmax) Above 2500 ng/dL at Week 12
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
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
Week 12 (0-168 hours after dosing)
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.
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.
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.
University of California (UCLA) (Site ID 111)
Santa Monica, California, 90403, United States
Accel Research Site Alcanza Clinical Research (Site ID 103)
DeLand, Florida, 32720, United States
First Submitted
October 21, 2026
First Posted
October 27, 2026
Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism
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.
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 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.
Contact the study team to confirm eligibility.
Floridian Clinical Research LLC (Site ID 101)
Miami Lakes, Florida, 33016, United States
Quality Research Center (Site ID 104)
Omaha, Nebraska, 68114, United States
AccuMed Research Associates (Site ID 106)
Garden City, New York, 11530, United States
Integrated Medical Professionals/Advanced Urology Centers of New York (Site ID 107)
New York, New York, 10016, United States
Brown University (Site ID 108)
Providence, Rhode Island, 02904, United States
Coastal Carolina Research Center (Site ID 102)
North Charleston, South Carolina, 29405, United States
Biobehavioral Research Center of Austin (Austin TX) (Site ID 105)
Austin, Texas, 78759, United States
Baylor College of Medicine (Site ID 109)
Houston, Texas, 77030, United States
Study Start
September 28, 2026
Actual (reported)Primary Completion
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
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