Trial · NCT02118714
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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. |
| 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 | Serum hormones levels will be tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum Inhibin B. |
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
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GET https://conductscience.org/api/trials/v1/NCT02118714/registered