A Study of the Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adult Men With Hypogonadotropic Hypogonadism (HH) (P07937)

NCT01709331 on ClinicalTrials.gov Phase 3 Organon and Co (industry) Started 2013-02-11 Completed

Riskier than 10% of active trials

Model scores of the 29,894 trials active now.

Model score 8% for any early termination, 1% 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 2015-04-08, after 2013-02-11 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 2015-04-08. 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: breast canceralfamonthstreatment withhuman
Phrases that lowered it: mkdrugscombinationor presencehistory or
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 3.9% (lowers risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 28 (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Design: single group (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
Sponsor's past trials: 383 (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Number of arms: 1 (raises risk) · Design
Sex: male (lowers risk) · Who can join
Drug's FAERS reports marked serious: 100% (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: 1 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 50 (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: 383 (typical: 32)
Sponsor's past termination rate: 3.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 28 (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: 2 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1 (typical: 412.5)
Drug's FAERS reports marked serious: 100% (typical: 85.6%)
Drug's FAERS reports with a death: 0% (typical: 15.9%)

Disease area and drugs

Disease areas: endocrine
Drugs matched to FDA substances: corifollitropin alfa

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

Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adolescent Males With Hypogonadotropic Hypogonadism (HH) (MK-8962-043) NCT03019575 · started 2017 · scored riskier than 16% of active trials completed
A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62% NCT01993225 · started 2014 · scored riskier than 57% of active trials completed
A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62% NCT01993212 · started 2014 · scored riskier than 58% of active trials completed
Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism NCT01270841 · started 2011 · scored riskier than 37% of active trials completed
To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone NCT00706719 · started 2008 · scored riskier than 15% 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.