Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature Ejaculation
Model scores of the 29,894 trials active now.
Model score 6% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 12% of the time (422 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 2009-04-30, after 2008-08-31 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 2009-04-30. 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) (lowers risk) · Wording
Phrases that raised it: definedtimemyocardialstrokefunction
Phrases that lowered it: and safetyefficacy andsafety ofthe efficacyparticipants -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Minimum age: 20 (lowers risk) · Who can join
-
Responsible party: not given (raises risk) · Design
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: No (lowers risk) · Design
-
Phase: 3 (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 10.6% (lowers risk) · Drug's FDA history
-
Primary purpose: treatment (raises risk) · Design
-
Number of arms: 3 (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, psychiatry: Yes (raises risk) · Disease area
-
Blinding: quadruple (lowers risk) · Design
-
Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 78.0% (lowers risk) · Drug's FDA history
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
- No (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 20 (typical: 18)
- Maximum age
- 70 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 6041 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1510 (typical: 412.5)
- Drug's FAERS reports marked serious
- 78.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry, urogenital
- Drugs matched to FDA substances
- paroxetine
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
- Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044 NCT01419470 · started 2011 · scored riskier than 12% of active trials completed
- Trial of PED-1 in Male Patients With Premature Ejaculation NCT01439984 · started 2011 · scored riskier than 8% of active trials completed
- Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation NCT01203202 · started 2010 · scored riskier than 11% of active trials completed
- IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE) NCT02232425 · started 2014 · scored riskier than 27% of active trials completed
- Proof of Mechanism in ELT NCT00861484 · started 2008 · scored riskier than 11% 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.