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Trial · NCT02061384

RA-2 13-cis Retinoic Acid (Isotretinoin)

NCT02061384, Phase 2, Completed, University of Washington; results first posted 2021-07-30

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. RA-2 13-cis Retinoic Acid (Isotretinoin). Trials, record NCT02061384. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02061384

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
RA-2 13-cis Retinoic Acid (Isotretinoin)
NCT number
NCT02061384
Status
Completed
Phases
Phase 2
Enrollment
20 participants, actual
Lead sponsor
University of Washington
Conditions
Male Infertility, Klinefelter's Syndrome, Y-chromosome Microdeletions
Interventions
13-cis retinoic acid, Calcitriol
First posted
2014-02-12
Last updated
2021-08-02
Results first posted
2021-07-30

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryMillions of Sperm Per EjaculateUp to 20-weeksMillions of sperm per ejaculate in men treated with 13-cis retinoic acid

Outcomes1

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYMillions of Sperm Per EjaculateUp to 20-weeksFirst 10 men received isotretinoin alone, next 10 men received both isotretinoin and calcitriolMillions of sperm per ejaculateMEDIAN

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Millions of Sperm Per Ejaculate13-cis Retinoic Acid2.5Inter-Quartile Range 0.1 to 5.9Millions of sperm per ejaculate
Millions of Sperm Per EjaculateCalcitriol 0.25 mcg3.8Inter-Quartile Range 2.1 to 13.0Millions of sperm per ejaculate

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTED13-cis Retinoic Acid + Oral Calcitriol10
Overall StudySTARTED13-cis Retinoic Acid10
Overall StudyCOMPLETED13-cis Retinoic Acid + Oral Calcitriol10
Overall StudyCOMPLETED13-cis Retinoic Acid10
Overall StudyNOT COMPLETED13-cis Retinoic Acid + Oral Calcitriol0
Overall StudyNOT COMPLETED13-cis Retinoic Acid0

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherUpper respiratory infectionRespiratory, thoracic and mediastinal disorders13-cis Retinoic Acid + Oral Calcitriol110
otherUpper respiratory infectionRespiratory, thoracic and mediastinal disorders13-cis Retinoic Acid110

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortality13-cis Retinoic Acid + Oral Calcitriol010
Total, all-cause mortality13-cis Retinoic Acid010
Total, other adverse events13-cis Retinoic Acid + Oral Calcitriol110
Total, other adverse events13-cis Retinoic Acid110
Total, serious adverse events13-cis Retinoic Acid + Oral Calcitriol010
Total, serious adverse events13-cis Retinoic Acid010

Papers23

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
1398387BACKGROUNDPubMed
2325571BACKGROUNDPubMed
2913914BACKGROUNDPubMed
3035879BACKGROUNDPubMed
3159708BACKGROUNDPubMed
3481225BACKGROUNDPubMed
3926808BACKGROUNDPubMed
6795047BACKGROUNDPubMed
8102079BACKGROUNDPubMed
8388780BACKGROUNDPubMed

1 to 10 of 23

See all 23 papers

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
13-cis Retinoic Acid + Oral Calcitriol vs 13-cis Retinoic Acid: deaths from any causeTrial comparisons
13-cis Retinoic Acid + Oral Calcitriol vs 13-cis Retinoic Acid: serious adverse eventsTrial comparisons

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT02061384

GET https://conductscience.org/api/trials/v1/NCT02061384/papers?page=2