Denosumab and Male Infertility: a RCT
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 5% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-05-31, after 2017-01-31 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 2023-05-31. 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
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Responsible party: sponsor investigator (raises risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Phase: 2 (raises risk) · Design
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: to determinediseasemenbowelcolitis
Phrases that lowered it: malediseasesto investigateinfertilitydental -
Design: parallel (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Number of arms: 2 (raises risk) · Design
-
Drug's FAERS reports marked serious: 65.9% (lowers risk) · Drug's FDA history
-
Primary purpose: treatment (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Maximum age: 64 (lowers risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
-
Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
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
- Yes (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 64 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 60707 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 21076 (typical: 412.5)
- Drug's FAERS reports marked serious
- 65.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 20.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- denosumab
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
- NAPO - Novel Approach for Oligospermia NCT06300229 · started 2024 · scored riskier than 40% of active trials completed
- TNFSF11 Inhibition and Fertility: a Prospective Study NCT02422108 · started 2015 · scored riskier than 66% of active trials completed
- Vitamin D Supplementation and Male Infertility: The CBG-study a Randomized Clinical Trial NCT01304927 · started 2011 · scored riskier than 33% of active trials completed
- A Trial to Compare Efficacy and Safety of Follitropin Delta Versus Placebo (Inactive Treatment) in the Treatment of Men With Idiopathic Infertility (Unexplained Reduction of Semen Quality) (ADAM) NCT05403476 · started 2022 · scored riskier than 39% of active trials terminated
- Effect of Letrozole on Seminal Parameters in Men With Non Obstructive Azoospermia and Severe Oligozoospermia. NCT02900105 · started 2015 · scored riskier than 9% 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.