Comparative Efficacy of Lidocaine Spray Versus Vaginal Misoprostol in IUD Insertion
Model scores of the 29,894 trials active now.
Model score 4% 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 14% of the time (741 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-07-30, after 2020-05-01 start.
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 2021-07-30. 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) (lowers risk) · Wording
Phrases that raised it: womenstudy isthe safetyreducingvaginal
Phrases that lowered it: efficacycompareadolescentsspraythe aim -
Sponsor's past termination rate: 0.7% (lowers risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 592 (raises risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports marked serious: 55.9% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: not given (lowers risk) · Design
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Drug's FAERS reports with a death: 7.5% (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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Responsible party: principal investigator (lowers risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Minimum age: not given (lowers risk) · Who can join
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Number of arms: 3 (lowers risk) · Design
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Collaborators: 1 (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
- 3 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 431 (typical: 32)
- Sponsor's past termination rate
- 0.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 592 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 75667 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 10137 (typical: 412.5)
- Drug's FAERS reports marked serious
- 55.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- lidocaine, 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
- Comparison Between 2 Doses of Misoprostol Before Intrauterine Device NCT02901561 · started 2016 · scored riskier than 7% of active trials completed
- Comparative Safety and Efficacy of Vaginal Misoprostol Versus Lidocaine-prilocaine Cream in Levonorgestrel IUD Insertion NCT04339348 · started 2020 · scored riskier than 4% of active trials completed
- Self-Administered Lidocaine Gel for Pain Management With IUD Insertion NCT02738203 · started 2016 · scored riskier than 32% of active trials completed
- Sub Lingual Misoprostol Before IUD Insertion in Women With Only Previous Cesarean Section NCT02141321 · started 2014 · scored riskier than 4% of active trials completed
- Diclofenac Plus Lidocaine Gel for Pain Relief During Intrauterine Device Insertion(IUD). NCT02332057 · started 2015 · scored riskier than 14% 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.