Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
Model scores of the 29,894 trials active now.
Model score 7% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (1,598 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 2009-08-31, after 2008-05-31 start.
Reason given by the sponsor: “safety”
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 2009-08-31. 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: canceractivemgand effectivebiopsies
Phrases that lowered it: 18 andbody massmass indexinclusivebmi -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Primary purpose: prevention (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Phase: 2 (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Blinding: single (lowers risk) · Design
-
Drug's FAERS reports with a death: 18.1% (lowers risk) · Drug's FDA history
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Number of arms: 3 (lowers risk) · Design
-
Drug's FAERS reports marked serious: 94.6% (raises risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Sponsor's past trials: 6 (lowers risk) · Sponsor's track record
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Maximum age: 45 (lowers risk) · Who can join
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Minimum age: 18 (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 5 (raises risk) · Sponsor's track record
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Sex: female (lowers 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
- prevention (typical: treatment)
- Blinding
- single (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 45 (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
- 6 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 5 (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
- 542 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 178 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- leuprolide
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
- Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine Fibroids NCT01451424 · started 2012 · scored riskier than 22% of active trials completed
- Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids NCT00737282 · started 2008 · scored riskier than 72% of active trials terminated
- Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids NCT02323646 · started 2015 · scored riskier than 16% of active trials completed
- A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids NCT02301897 · started 2015 · scored riskier than 20% of active trials completed
- Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids NCT00735553 · started 2008 · scored riskier than 85% of active trials terminated
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.