Trial · NCT02118714
Atrasentan Spermatogenesis and Testicular Function
NCT02118714, Phase 2, Completed, AbbVie; results first posted 2019-05-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Atrasentan Spermatogenesis and Testicular Function. Trials, record NCT02118714. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02118714
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Atrasentan Spermatogenesis and Testicular Function
- NCT number
- NCT02118714
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Nephropathy, Diabetes
- Interventions
- Atrasentan
- First posted
- 2014-04-21
- Last updated
- 2019-05-07
- Other registries' IDs
- eudract:2016-000722-19
- Results first posted
- 2019-05-07
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With a Sperm Concentration < 15 Million Per mL by Treatment Week 26 | Up to 26 weeks | Percentage of Subjects with a Sperm Concentration \< 15 million per mL by Treatment Week 26. Sperm concentration was calculated as measure of the number sperm per milliliter of semen. Duplicate semen samples were collected. The average of the 2 samples were used as the value for that scheduled collection period. |
| 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 | The percentage of participants who entered the Observational Period and did not return to within 15% of Baseline sperm concentration or above during the 52-week Observational Period. Duplicate semen samples were to be collected during the Observational Period. Sperm concentration was calculated as measure of the number sperm per milliliter of semen. Duplicate semen samples were collected. The average of the 2 samples were used as the value for that scheduled collection period. |
| 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 | Duplicate semen samples will be collected during the Treatment and Observational Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a decrease in sperm concentration. |
| 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 | Duplicate semen samples will be collected during the Treatment and Observation Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a lower sperm motility (worsening). |
| 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 | Duplicate semen samples will be collected during the Treatment and Observational Periods. The percentage of sperm with normal versus abnormal morphology will be determined via microscopic analysis. A positive change from baseline indicates an improved sperm morphology. |
| 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 | Duplicate semen samples will be collected during the Treatment and Observation Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a decrease in semen volume. |
| 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 | Serum hormones levels will be tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum testosterone. |
| 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 | Serum hormones levels were tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum estradiol. |
| 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 | Serum hormones levels will be tested during the Treatment and Observational Periods. A positive change from baseline indicated an increase in serum lutenizing hormone. |
| 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 | Serum hormones levels will be tested during the Treatment and Observational Periods. A positive change from baseline indicated an increase in serum follicle stimulating hormone. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With a Sperm Concentration < 15 Million Per mL by Treatment Week 26 | Atrasentan | 23.5 | percentage of participants | ||
| 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 | Atrasentan | 11.8 | percentage of participants | ||
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration | Atrasentan | Treatment Period Week 13 | 2.2 | Standard Deviation 42.21 | sperm * million per milliliter(X10^6/mL) |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration | Atrasentan | Treatment Period Week 26 | -10.6 | Standard Deviation 53.44 | sperm * million per milliliter(X10^6/mL) |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration | Atrasentan | Observation Period Week 13 | 35.8 | Standard Deviation 113.60 | sperm * million per milliliter(X10^6/mL) |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration | Atrasentan | Observation Period Week 26 | -16.5 | Standard Deviation 0.00 | sperm * million per milliliter(X10^6/mL) |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration | Atrasentan | Observation Period Week 39 | -27.5 | Standard Deviation 19.09 | sperm * million per milliliter(X10^6/mL) |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration | Atrasentan | Observation Period Week 52 | -25.8 | Standard Deviation 1.06 | sperm * million per milliliter(X10^6/mL) |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility | Atrasentan | Treatment Period Week 13 | -5.8 | Standard Deviation 13.65 | percent motility |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility | Atrasentan | Treatment Period Week 26 | -7.4 | Standard Deviation 15.77 | percent motility |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atrasentan | 20 | |
| Overall Study | COMPLETED | Atrasentan | 17 | |
| Overall Study | NOT COMPLETED | Atrasentan | 3 |
Source ClinicalTrials.gov
Adverse events58
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Atrasentan | 1 | 20 | 1 |
| other | HAEMORRHAGIC ANAEMIA | Blood and lymphatic system disorders | Atrasentan | 1 | 20 | 1 |
| other | ANGINA PECTORIS | Cardiac disorders | Atrasentan | 1 | 20 | 1 |
| other | LEFT VENTRICULAR HYPERTROPHY | Cardiac disorders | Atrasentan | 1 | 20 | 1 |
| other | EUSTACHIAN TUBE DYSFUNCTION | Ear and labyrinth disorders | Atrasentan | 1 | 20 | 1 |
| other | DIARRHOEA | Gastrointestinal disorders | Atrasentan | 2 | 20 | 3 |
| other | GASTRITIS | Gastrointestinal disorders | Atrasentan | 1 | 20 | 1 |
| other | NAUSEA | Gastrointestinal disorders | Atrasentan | 1 | 20 | 1 |
| other | TOOTH DISORDER | Gastrointestinal disorders | Atrasentan | 1 | 20 | 1 |
| other | UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | Atrasentan | 1 | 20 | 1 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atrasentan | 0 | 20 |
| Total, other adverse events | Atrasentan | 12 | 20 |
| Total, serious adverse events | Atrasentan | 3 | 20 |
Source ClinicalTrials.gov
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/NCT02118714
GET https://conductscience.org/api/trials/v1/NCT02118714/results?page=2