A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy

NCT01816295 on ClinicalTrials.gov Phase 3 Eli Lilly and Company (industry) Started 2013-05-31 Completed

Riskier than 63% of active trials

Model scores of the 29,894 trials active now.

Model score 19% 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 0% of the time (39 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 2015-04-30, after 2013-05-31 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 2015-04-30. 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: to screeningcoronarymonths priorventricularheart
Phrases that lowered it: testosteroneprostatetopicalcancerarea
Accepts healthy volunteers: No (raises risk) · Who can join
Has a data monitoring committee: Yes (raises risk) · Design
Sponsor's past termination rate: 5.1% (lowers risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Drug's FAERS reports with a death: 6.0% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 177 (lowers risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Sponsor's past trials: 747 (raises risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Blinding: triple (raises risk) · Design
Drug's FAERS reports marked serious: 64.5% (lowers risk) · Drug's FDA history
Drug's FAERS reports before start: 3129 (lowers risk) · Drug's FDA history
Sex: male (lowers risk) · Who can join
Disease area, neurology: No (lowers risk) · Disease area
Disease area, cancer: No (lowers 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: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: triple (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: not given (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: 747 (typical: 32)
Sponsor's past termination rate: 5.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 177 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 2 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 3129 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 715 (typical: 412.5)
Drug's FAERS reports marked serious: 64.5% (typical: 85.6%)
Drug's FAERS reports with a death: 6.0% (typical: 15.9%)

Disease area and drugs

Disease areas: endocrine
Drugs matched to FDA substances: testosterone, testosterone propionate

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

The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate NCT02921386 · started 2016 · scored riskier than 6% 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
A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men NCT02722278 · started 2016 · scored riskier than 19% of active trials completed
A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations NCT00702650 · started 2008 · scored riskier than 7% of active trials completed
A Study of Effect of Deodorant and Axillary Hair on Testosterone Absorption in Healthy Participants NCT01725451 · started 2012 · scored riskier than 1% 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.