Efficacy and Safety Study of the Misoprostol Vaginal Priming Insert (MVPI) Prior to Hysteroscopy
Model scores of the 29,894 trials active now.
Model score 20% 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 13% of the time (1,304 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 2010-11-30, after 2010-01-31 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 2010-11-30. 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: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: womensubjectstudy drugprocedureassess the
Phrases that lowered it: and safetyhealthyefficacy andvisitsafety of -
Phase: 2 (raises risk) · Design
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Sponsor's past termination rate: 13.0% (raises risk) · Sponsor's track record
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Blinding: triple (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 8.0% (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 65.7% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 20 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Maximum age: 80 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 80 (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
- 46 (typical: 32)
- Sponsor's past termination rate
- 13.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 20 (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
- 3786 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 615 (typical: 412.5)
- Drug's FAERS reports marked serious
- 65.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- misoprostol
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
- Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial NCT00572819 · started 2008 · scored riskier than 15% of active trials completed
- LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study NCT01254292 · started 2011 · scored riskier than 6% of active trials completed
- Misoprostol Vaginal Insert (MVI) 100, 150, 200 mcg for Cervical Ripening and Induction of Labor NCT00828711 · started 2009 · scored riskier than 45% of active trials completed
- Cervical Priming With Misoprostol Prior to Operative Hysteroscopy NCT01024270 · started 2008 · scored riskier than 7% of active trials completed
- Optimum Misoprostol Dose Prior to Office Hysteroscopy NCT01612065 · started 2012 · 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.