Trial · NCT02118714
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With a Sperm Concentration < 15 Million Per mL by Treatment Week 26 | Up to 26 weeks | Evaluable Set: Subjects who met 1 of the following: Study drug compliance ≥ 70%, completed Treatment Period, all planned sperm samples collected; or 2) at least 1 dose study drug, a sperm concentration value that was \<15 million/mL observed by the end of the Treatment Period or had a ≥50% reduction from Baseline at the end of the Treatment Period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Entered the Observation Period and Did Not Return to Within 15% of Baseline Sperm Concentration or Above During the 52-Week Observational Period | Up to 52 weeks after the Treatment Period | Evaluable Set | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration | From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 | All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point. | sperm * million per milliliter(X10^6/mL) | MEAN |
| SECONDARY | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility | From Week 0 up to Treatment Period Week 26 and Observation Observation Week 52 | All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point. | percent motility | MEAN |
| SECONDARY | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology | From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 | All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point. | percentage of normal | MEAN |
| SECONDARY | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume | From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52 | All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point. | milliliter (mL) | MEAN |
| SECONDARY | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone | From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 | All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point. | nanomole/liter (nmol/L) | MEAN |
| SECONDARY | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol | From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 | All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point. | Picomoles Per Litre (pmol/L) | MEAN |
| SECONDARY | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH) | From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52 | All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point. | International Units/Liter (IU/L) | MEAN |
| SECONDARY | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH) | From Week 0 to Treatment Week 26 and Observation Week 52 | All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point. | International Units/Liter (IU/L) | MEAN |
| SECONDARY | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B | From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 | All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point. | picogram per milliliter (pg/mL) | MEAN |
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.
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GET https://conductscience.org/api/trials/v1/NCT02118714/outcomes