Pregabalin for the Treatment of Vulvodynia
Model scores of the 29,894 trials active now.
Model score 21% for any early termination, 34% 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 (130 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 2013-04-30, after 2009-02-28 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 2013-04-30. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: painchronicsymptomspregabalinto determine
Phrases that lowered it: areaappliedhormonalirritationskin disease -
Design: crossover (lowers risk) · Design
-
Sponsor's past termination rate: 13.0% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports with a death: 4.8% (lowers risk) · Drug's FDA history
-
Blinding: triple (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 30 (lowers risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Drug's FAERS reports in the prior 12 months: 3575 (lowers risk) · Drug's FDA history
-
Drug's FAERS reports marked serious: 91.1% (raises risk) · Drug's FDA history
-
Number of arms: 2 (raises risk) · Design
-
Drug's FAERS reports before start: 12100 (raises risk) · Drug's FDA history
-
Keywords listed: 5 (lowers risk) · Design
-
Collaborators: 0 (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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- 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
- 30 (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
- 12100 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3575 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- pregabalin
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
- Novel Topical Therapies for the Treatment of Genital Pain NCT02099006 · started 2013 · scored riskier than 88% of active trials completed
- Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment NCT03682601 · started 2018 · scored riskier than 7% of active trials terminated
- Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments NCT03844412 · started 2019 · scored riskier than 54% of active trials completed
- Savella in Treatment for Provoked Vestibulodynia NCT01304589 · started 2010 · scored riskier than 14% of active trials completed
- Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study NCT01996384 · started 2013 · scored riskier than 33% 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.