Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (389 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
Terminated on 2010-05-31, after 2009-07-31 start.
Reason given by the sponsor: “enrollment”
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 2010-05-31. 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) (raises risk) · Wording
Phrases that raised it: heartfailureto determinemyocardialplacebo
Phrases that lowered it: and safetyefficacy andsafety oftestosteronevisit -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Sponsor's past termination rate: 6.1% (lowers risk) · Sponsor's track record
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Minimum age: 50 (lowers risk) · Who can join
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Drug's FAERS reports with a death: 7.1% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Disease area, cancer: 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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Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 15 (lowers risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (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
- 50 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 33 (typical: 32)
- Sponsor's past termination rate
- 6.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 15 (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
- 986 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 227 (typical: 412.5)
- Drug's FAERS reports marked serious
- 72.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- 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
- The VO2 Increase With Testosterone Addition - Heart Failure (VITA-HF) Trial NCT01469988 · started 2012 · scored riskier than 72% of active trials terminated
- Efficacy, Pharmacokinetics and Safety of Testosterone NCT01370369 · started 2011 · scored riskier than 8% of active trials completed
- Maintaining Suppression of Testosterone With Transdermal Estradiol Gel NCT02349386 · started 2015 · scored riskier than 64% of active trials terminated
- Testopel ® vs. Generic Testosterone Pellets. NCT04523480 · started 2020 · scored riskier than 9% 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.