Impact of Estradiol Addback
Model scores of the 29,894 trials active now.
Model score 9% 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 11% of the time (918 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 2018-12-30, after 2013-05-31 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 2018-12-30. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: untreatedagesacutestrokemen
Phrases that lowered it: drugs60limitalcoholhealthy -
Design: crossover (lowers risk) · Design
-
Sponsor's past termination rate: 14.1% (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 60.9% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Minimum age: 60 (lowers risk) · Who can join
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Primary purpose: basic science (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 167 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 5.8% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: triple (raises risk) · Design
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Sex: male (lowers risk) · Who can join
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Number of arms: 4 (lowers risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Sponsor's past trials: 425 (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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
- 4 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 60 (typical: 18)
- Maximum age
- 80 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 425 (typical: 32)
- Sponsor's past termination rate
- 14.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 167 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 13616 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2182 (typical: 412.5)
- Drug's FAERS reports marked serious
- 60.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- anastrozole, degarelix, 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
- Estradiol-Receptor Blockade in Older Men and Women NCT02271282 · started 2014 · scored riskier than 20% of active trials completed
- The Effect of Mixed Exercise and Metabolic Stress in Relationship to Age in Healthy Men NCT01800370 · started 2013 · scored riskier than 6% of active trials completed
- Impact of Endogenous E2 on SSI and GH Rebound NCT02026973 · started 2014 · scored riskier than 18% of active trials completed
- Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men NCT00740194 · started 2008 · scored riskier than 13% of active trials completed
- The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate NCT02921386 · started 2016 · scored riskier than 6% 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.