A Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, and Tolerability of LPRI-424, 13 Cycles
Model scores of the 29,894 trials active now.
Model score 4% 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 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 2023-09-08, after 2019-12-03 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 2023-09-08. 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
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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: priorsquamoussubject isbreastnegative
Phrases that lowered it: hivsafetyor suspectedvirusaged -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports marked serious: 48.7% (lowers risk) · Drug's FDA history
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Primary purpose: prevention (lowers risk) · Design
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Drug's FAERS reports with a death: 1.6% (lowers risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Number of arms: 1 (raises risk) · Design
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Collaborators: 1 (raises risk) · Design
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Drug's FAERS reports before start: 22498 (raises risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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
- prevention (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 13 (typical: 18)
- Maximum age
- 45 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 2 (typical: 32)
- Sponsor's past termination rate
- 0% (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
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 22498 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1321 (typical: 412.5)
- Drug's FAERS reports marked serious
- 48.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- dienogest, ethinyl estradiol
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
- Safety, Efficacy, Tolerability and Pharmacokinetics of LF111 (Drospirenone 4.0 mg) During 13 Cycles NCT02269241 · started 2014 · scored riskier than 3% of active trials completed
- Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles NCT05139121 · started 2021 · scored riskier than 9% of active trials completed
- Study of Efficacy, Cycle Control, and Safety of a NES-E2 Contraceptive Vaginal Ring NCT03432416 · started 2018 · scored riskier than 6% of active trials completed
- Annovera™ Drug-Drug Interaction Study NCT04290390 · started 2020 · scored riskier than 4% of active trials completed
- The Effects of Annovera™ and Tampon Co-Usage on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol NCT04272008 · started 2020 · scored riskier than 4% 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.