Drug Interaction Oral Contraceptive Pill (OCP)
Model scores of the 29,894 trials active now.
Model score 4% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (776 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 2010-06-30, after 2010-01-31 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 2010-06-30. 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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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: bmschronicuncontrolledillnesspregnancy
Phrases that lowered it: healthypharmacokineticssubjectsbmifemale -
Primary purpose: not given (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Drug's FAERS reports marked serious: 47.3% (lowers risk) · Drug's FDA history
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Design: single group (raises 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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Responsible party: not given (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 114 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Sponsor's past trials: 225 (raises risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Blinding: none (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor's past termination rate: 7.6% (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Sex: female (raises risk) · Who can join
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Disease area, neurology: No (lowers risk) · Disease area
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Number of arms: 3 (lowers 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
- 1 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- not given (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 40 (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
- 225 (typical: 32)
- Sponsor's past termination rate
- 7.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 114 (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
- 2791 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 535 (typical: 412.5)
- Drug's FAERS reports marked serious
- 47.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, digestive
- Drugs matched to FDA substances
- asunaprevir, ethinyl estradiol, norgestimate
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
- A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI) NCT02480881 · started 2015 · scored riskier than 2% of active trials completed
- Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female Subjects NCT00983957 · started 2009 · scored riskier than 1% of active trials completed
- The Effect of BMS-986165 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients NCT03262727 · started 2017 · scored riskier than 3% of active trials completed
- Study of Combined Oral Contraceptive Effects in Female Subjects NCT02157467 · started 2014 · scored riskier than 4% of active trials completed
- The Effect of BMS-986195 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients NCT03262740 · started 2017 · scored riskier than 3% 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.