Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men
Model scores of the 29,894 trials active now.
Model score 4% for any early termination, 0% 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 (918 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-03-31, after 2015-04-30 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 2016-03-31. 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: prostatediabetesmellituscancereffective
Phrases that lowered it: healthyliverbodyvolunteersthe pharmacokinetics -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Primary purpose: other (lowers risk) · Design
-
Phase: 1 (lowers risk) · Design
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports with a death: 6.2% (lowers risk) · Drug's FDA history
-
Responsible party: sponsor investigator (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 64.2% (lowers risk) · Drug's FDA history
-
Blinding: triple (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
-
Maximum age: 50 (lowers risk) · Who can join
-
Number of arms: 2 (raises risk) · Design
-
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
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- other (typical: treatment)
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 50 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- 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
- 7195 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3458 (typical: 412.5)
- Drug's FAERS reports marked serious
- 64.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- testosterone
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
- Study of the Safety, and Sperm and Gonadotropin Suppression of a Contraceptive Gel in Normal Men NCT00891228 · started 2009 · scored riskier than 4% of active trials completed
- Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males NCT02994602 · started 2017 · scored riskier than 2% of active trials completed
- Study of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception NCT03452111 · started 2018 · scored riskier than 4% of active trials completed
- The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone) NCT01386606 · started 2011 · scored riskier than 17% of active trials completed
- Time to Eugonadal Range, Time to Steady State and Drying Time NCT01228071 · started 2010 · scored riskier than 10% 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.