The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 15% of the time (7,397 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2011-10-31, after 2011-06-30 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2011-10-31. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: cancerprostateiitumorsubject has
Phrases that lowered it: healthyparticipanttopicalkguse of -
Sponsor's past termination rate: 48% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Blinding: single (lowers risk) · Design
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Number of arms: 4 (lowers risk) · Design
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Drug's FAERS reports with a death: 7.0% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Design: parallel (raises risk) · Design
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Drug's FAERS reports marked serious: 69.2% (lowers risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 3 (lowers risk) · Sponsor's track record
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Maximum age: 65 (lowers risk) · Who can join
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Minimum age: 18 (raises risk) · Who can join
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Sponsor's past trials: 25 (lowers risk) · Sponsor's track record
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Collaborators: 0 (raises risk) · Design
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- single (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 25 (typical: 32)
- Sponsor's past termination rate
- 48% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 1693 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 419 (typical: 412.5)
- Drug's FAERS reports marked serious
- 69.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- endocrine
- Drugs matched to FDA substances
- enclomiphene, testosterone
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62% NCT01993212 · started 2014 · scored riskier than 58% of active trials completed
- A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62% NCT01993225 · started 2014 · scored riskier than 57% of active trials completed
- Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism NCT01270841 · started 2011 · scored riskier than 37% of active trials completed
- Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism NCT01532414 · started 2012 · scored riskier than 40% of active trials completed
- Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism NCT01739595 · started 2012 · scored riskier than 40% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.