Trial · NCT07898072
Safety and Efficacy of Weekly Testosterone Cypionate Auto-Injector in Men With Hypogonadism
NCT07898072, Phase 3, Recruiting, Amneal Pharmaceuticals, LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Weekly Testosterone Cypionate Auto-Injector in Men With Hypogonadism. Trials, record NCT07898072. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07898072
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Weekly Testosterone Cypionate Auto-Injector in Men With Hypogonadism
- NCT number
- NCT07898072
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 190 participants, estimated
- Lead sponsor
- Amneal Pharmaceuticals, LLC
- Conditions
- Male Hypogonadism
- Interventions
- Testosterone Cypionate 75 mg, Testosterone cypionate 50 mg, Testosterone cypionate 100 mg
- First posted
- 2026-10-27
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Average Serum Total Testosterone Concentration Within 300-1100 ng/dL at Week 12 | 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. |
| Secondary | Percentage of Participants With Maximum Serum Total Testosterone Concentration (Cmax) Below 1500 ng/dL at Week 12 | Week 12 (0-168 hours after dosing) | 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. |
| Secondary | 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) | 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. |
| Secondary | Number of Participants With Maximum Serum Total Testosterone Concentration (Cmax) Above 2500 ng/dL at Week 12 | Week 12 (0-168 hours after dosing) | 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. |
| Secondary | 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) | 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. |
| Secondary | 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) | 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%. |
| Secondary | Average Serum Total Testosterone Concentration (Cavg0-168h) in Participants Receiving 100 mg at Week 12 | Week 12 (0-168 hours after dosing) | 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. |
| Secondary | Average Serum Total Testosterone Concentration (Cavg0-168h) in Participants Receiving 50 mg at Week 12 | Week 12 (0-168 hours after dosing) | 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. |
| Secondary | Area Under the Serum Total Testosterone Concentration-Time Curve (AUC0-168h) Following the 75 mg Dose at Week 1 | Week 1 (0-168 hours after the first dose) | 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. |
| Secondary | Maximum Serum Total Testosterone Concentration (Cmax) Following the 75 mg Dose at Week 1 | Week 1 (0-168 hours after the first dose) | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07898072
GET https://conductscience.org/api/trials/v1/NCT07898072/registered