Trial · NCT07898072
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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. |
| Secondary | Time to Maximum Serum Total Testosterone Concentration (Tmax) Following the 75 mg Dose at Week 1 | Week 1 (0-168 hours after the first dose) | 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. |
| Secondary | Average Serum Total Testosterone Concentration (Cavg0-168h) Following the 75 mg Dose at Week 1 | Week 1 (0-168 hours after the first dose) | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07898072/registered