LCS16 vs. COC User Satisfaction and Tolerability Study
Model scores of the 29,894 trials active now.
Model score 7% 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 10% of the time (1,463 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-08-05, after 2017-03-13 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 2022-08-05. 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: acutecervicaltreatedchroniccerebral
Phrases that lowered it: evaluatescreening visitthe screeninginclusivehealthy -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 33.4% (lowers risk) · Drug's FDA history
-
Phase: 3 (lowers risk) · Design
-
Sponsor's past termination rate: 6.7% (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 0.4% (lowers risk) · Drug's FDA history
-
Has a data monitoring committee: No (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 170 (lowers risk) · Sponsor's track record
-
Sponsor's past trials: 731 (raises risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Drug's FAERS reports before start: 134001 (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, neurology: No (lowers risk) · Disease area
-
Drug's FAERS reports in the prior 12 months: 14378 (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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 29 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 731 (typical: 32)
- Sponsor's past termination rate
- 6.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 170 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 134001 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 14378 (typical: 412.5)
- Drug's FAERS reports marked serious
- 33.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- drospirenone, ethinyl estradiol, levonorgestrel
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
- LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study NCT01254292 · started 2011 · scored riskier than 6% of active trials completed
- GA Levonorgestrel Intrauterine Contraceptive System (LCS) Phase III Study China NCT00884260 · started 2009 · scored riskier than 4% of active trials completed
- Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill NCT03585712 · started 2018 · scored riskier than 4% of active trials completed
- A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception NCT00995150 · started 2009 · scored riskier than 6% of active trials terminated
- Safety and Contraceptive Efficacy of an Intravaginal Ring With LNG (Levonorgestrel) Over One Year in Healthy Women NCT02403401 · started 2015 · scored riskier than 6% 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.