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Trial · NCT03201445

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13Baseline to Week 13
The Semen Analysis Set included all randomized and treated (≥ 1 dose of double-blind study drug) participants who had 2 semen samples that were eligible for mean calculation at baseline and at the Week 13 analysis visit with the date of the first chronologic semen sample used for purposes of assigning analysis visit windows.
percentage of participantsNUMBER
SECONDARYPercentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26Baseline to Week 26
Participants in the Week 26 Semen Analysis Set (included all participants who took ≥ 1 dose of study drug and had 2 evaluable samples at baseline and at ≥ 1 postbaseline measurement at/after Week 26 or OL Week 13) with available data were analyzed.
percentage of participantsNUMBER
SECONDARYChange From Baseline in Sperm Total Motility at Week 13Baseline, Week 13Participants in the Semen Analysis Set were analyzed.percentage of motile spermsMEDIAN
SECONDARYChange From Baseline in Sperm Total Motility at Week 26Baseline, Week 26Participants in the Week 26 Semen Analysis Set with available data were analyzed.percentage of motile spermsMEDIAN
SECONDARYChange From Baseline in Total Sperm Count at Week 13Baseline, Week 13Participants in the Semen Analysis Set were analyzed.million sperm cells/ejaculateMEDIAN
SECONDARYChange From Baseline in Total Sperm Count at Week 26Baseline, Week 26Participants in the Week 26 Semen Analysis Set with available data were analyzed.million sperm cells/ejaculateMEDIAN
SECONDARYChange From Baseline in Sperm Concentration at Week 13Baseline, Week 13Participants in the Semen Analysis Set were analyzed.million sperm cells/mLMEDIAN
SECONDARYChange From Baseline in Sperm Concentration at Week 26Baseline, Week 26Participants in the Week 26 Semen Analysis Set with available data were analyzed.million sperm cells/mLMEDIAN
SECONDARYChange From Baseline in Ejaculate Volume at Week 13Baseline, Week 13Participants in the Semen Analysis Set were analyzed.mLMEDIAN
SECONDARYChange From Baseline in Ejaculate Volume at Week 26Baseline, Week 26Participants in the Week 26 Semen Analysis Set with available data were analyzed.mLMEDIAN
SECONDARYChange From Baseline in Percent Normal Sperm Morphology at Week 13Baseline, Week 13Participants in the Semen Analysis Set were analyzed.percentage of normal spermsMEDIAN
SECONDARYChange From Baseline in Percent Normal Sperm Morphology at Week 26Baseline, Week 26Participants in the Week 26 Semen Analysis Set with available data were analyzed.percentage of normal spermsMEDIAN

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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