Pharmacokinetic Study to Evaluate Double-Dose Levonorgestrel Emergency Contraception in Combination With Efavirenz-Based Antiretroviral Therapy or Rifampicin-Containing Anti-Tuberculosis Therapy
Model scores of the 29,894 trials active now.
Model score 12% 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 13% of the time (331 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-11-30, after 2019-05-06 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 2020-11-30. 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
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: or equalequal togreater thanhourspurpose of
Phrases that lowered it: participantparticipantshiv rnaulnpharmacokinetic -
Phase: 2 (raises risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 11.4% (raises risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 33.4% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Number of arms: 4 (lowers risk) · Design
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Drug's FAERS reports with a death: 0.1% (lowers risk) · Drug's FDA history
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Minimum age: 16 (raises risk) · Who can join
-
Collaborators: 1 (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
- 2
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 16 (typical: 18)
- Maximum age
- not given (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
- 44 (typical: 32)
- Sponsor's past termination rate
- 11.4% (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
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 144310 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 12215 (typical: 412.5)
- Drug's FAERS reports marked serious
- 33.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, immunology, urogenital
- Drugs matched to FDA substances
- 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
- Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals NCT04272242 · started 2021 · scored riskier than 17% of active trials terminated
- Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO) NCT03446573 · started 2018 · scored riskier than 11% of active trials completed
- Rapid Test and Treat Dolutegravir Plus Lamivudine Study in Newly Diagnosed Human Immunodeficiency Virus (HIV)-1 Infected Adults NCT03945981 · started 2019 · scored riskier than 12% of active trials completed
- Pausing Antiretroviral Treatment Under Structured Evaluation NCT06031272 · started 2024 · scored riskier than 20% of active trials completed
- The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE NCT03635788 · started 2019 · scored riskier than 16% 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.