Evaluation of Testosterone Nasal Gel in Hypogonadal Boys
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 7% of the time (10,462 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-04-11, after 2018-03-01 start.
Reason given by the sponsor: “enrollment”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2022-04-11. 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) (raises risk) · Wording
Phrases that raised it: kidneystudyparentable tohistory
Phrases that lowered it: participantspatientsnasalfractureeligible -
Phase: 1 (lowers risk) · Design
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Primary purpose: other (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 54.6% (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 4.9% (lowers risk) · Drug's FDA history
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Maximum age: 17 (raises risk) · Who can join
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Drug's FAERS reports in the prior 12 months: 3900 (raises risk) · Drug's FDA history
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Drug's FAERS reports before start: 27019 (raises risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Minimum age: 12 (raises risk) · Who can join
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Number of arms: 2 (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
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- other (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 12 (typical: 18)
- Maximum age
- 17 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 27019 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3900 (typical: 412.5)
- Drug's FAERS reports marked serious
- 54.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- endocrine
- Drugs matched to FDA substances
- 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
- Efficacy and Tolerability of an Intra-Nasal Testosterone Product NCT00975650 · started 2009 · scored riskier than 9% of active trials completed
- Efficacy, Pharmacokinetics and Safety of Testosterone NCT01370369 · started 2011 · scored riskier than 8% of active trials completed
- PK Study of Testosterone Nasal Gel (TBS-2) in Healthy Premenopausal Women NCT01364623 · started 2011 · scored riskier than 2% of active trials completed
- Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism NCT02081300 · started 2014 · scored riskier than 11% of active trials completed
- Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men NCT01104246 · started 2010 · scored riskier than 5% 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.