Efficacy of Intracavernosal as add-on Therapy to Sildenafil 100 mg on Demand Compared to Sildenafil 100 mg on Demand for the Treatment of Erectile Dysfunction (ED) Not Sufficiently Responsive to Standard Therapy With Phosphodiesterase Type 5 Inhibitors
Model scores of the 29,894 trials active now.
Model score 24% for any early termination, 7% 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 (407 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-11-15, after 2022-03-18 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 2024-11-15. 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: pressure90with chronicsclerosismm hg
Phrases that lowered it: mgweeksopen labelclinical studydisorders -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 14.4% (raises risk) · Sponsor's track record
-
Phase: 2 (raises risk) · Design
-
Sponsor's past trials: 956 (raises risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 285 (raises risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports marked serious: 96.1% (raises risk) · Drug's FDA history
-
Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports with a death: 14.1% (lowers risk) · Drug's FDA history
-
Primary purpose: treatment (raises risk) · Design
-
Disease area, psychiatry: Yes (raises risk) · Disease area
-
Number of arms: 2 (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
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 80 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 956 (typical: 32)
- Sponsor's past termination rate
- 14.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 285 (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
- 4826 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 381 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 14.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry, urogenital
- Drugs matched to FDA substances
- investigational product
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
- Phase 2A Clinical Trial Evaluating the Potential Activity and Safety of hMaxi-K Gene for ED NCT02713789 · started 2015 · scored riskier than 59% of active trials completed
- Efficacy and Tolerability Study of Avanafil in Russia NCT02503306 · started 2015 · scored riskier than 12% of active trials completed
- Efficacy and Safety Study of Tunodafil Hydrochloride Tablets in Erectile Dysfunction NCT07692867 · started 2021 · scored riskier than 37% of active trials completed
- A New Sildenafil Oral Film in Patients With Erectile Dysfunction NCT05490680 · started 2024 · scored riskier than 10% of active trials completed
- Clinical Trial Using Topically Applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction NCT03813992 · started 2018 · scored riskier than 22% 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.