Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS

NCT01482286 on ClinicalTrials.gov Phase 3 Pennington Biomedical Research Center (academic or other) Started 2012-05-31 Terminated

Riskier than 9% of active trials

Model scores of the 29,894 trials active now.

Model score 7% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (607 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

Terminated on 2016-12-31, after 2012-05-31 start.

Reason given by the sponsor: “enrollment”

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 2016-12-31. 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: syndromecellivcancerrandomization
Phrases that lowered it: indexweightbodyindividualsphysical
Accepts healthy volunteers: No (raises risk) · Who can join
Minimum age: 20 (lowers risk) · Who can join
Disease area, cancer: Yes (raises risk) · Disease area
Sponsor's past termination rate: 5.6% (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 7.5% (lowers risk) · Drug's FDA history
Phase: 3 (lowers risk) · Design
Design: parallel (raises risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Drug's FAERS reports marked serious: 62.1% (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Number of arms: 4 (lowers risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Disease area, neurology: No (lowers risk) · Disease area
Responsible party: principal investigator (lowers risk) · Design
Collaborators: 1 (raises risk) · Design
Blinding: double (raises risk) · Design
Drug's FAERS reports in the prior 12 months: 13758 (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: 4 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: double (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 1 (typical: 0)
Keywords listed: 4 (typical: 1)

Who can join

Minimum age: 20 (typical: 18)
Maximum age: 40 (typical: 71)
Sex: female (typical: all)
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 36 (typical: 32)
Sponsor's past termination rate: 5.6% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 13 (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: 61039 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 13758 (typical: 412.5)
Drug's FAERS reports marked serious: 62.1% (typical: 85.6%)
Drug's FAERS reports with a death: 7.5% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, metabolic, urogenital, endocrine
Drugs matched to FDA substances: metformin

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

Androgen Excess as a Cause for Adipogenic Dysfunction in PCOS Women NCT01889199 · started 2013 · scored riskier than 13% of active trials completed
Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women NCT00704912 · started 2008 · scored riskier than 23% of active trials completed
Comparing the Effects of Oral Contraceptive Pills Versus Metformin NCT03229057 · started 2018 · scored riskier than 15% of active trials completed
Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS NCT03480022 · started 2018 · scored riskier than 21% of active trials completed
Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility NCT02432209 · started 2015 · scored riskier than 28% 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.