AMP002 Phase III Contraceptive Study
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 5% 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 2018-11-29, after 2017-07-24 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 2018-11-29. 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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Sponsor's past termination rate: 25% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subjectpregnancymonths afterwomenvaginal
Phrases that lowered it: safety ofthe investigatorscreeningefficacy andexamination -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Primary purpose: prevention (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: single group (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Sponsor's past trials: 4 (lowers risk) · Sponsor's track record
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Maximum age: 35 (raises risk) · Who can join
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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
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 35 (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
- 4 (typical: 32)
- Sponsor's past termination rate
- 25% (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
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- none matched
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
- Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel NCT01306331 · started 2011 · scored riskier than 6% of active trials completed
- Safety and Pharmacokinetics of Dapivirine Vaginal Ring in Post-menopausal Women NCT02010593 · started 2013 · scored riskier than 7% of active trials completed
- A Multi-center, Open-label, Randomized, Parallel Group Study to Evaluate Pharmacokinetic Profile, Effects on the Mechanisms of Contraceptive Efficacy and Safety of Two Progestin-only Patches Containing Different Doses of Levonorgestrel (LNG) NCT01166412 · started 2010 · scored riskier than 4% of active trials completed
- A Dose-finding Study to Evaluate the Effect of a Contraceptive Vaginal Ring, Releasing Nestorone® and Estradiol, on Cycle Control, Ovulation Inhibition, and Pharmacokinetics in Normal Cycling Women NCT01586000 · started 2012 · scored riskier than 8% of active trials completed
- Safety, Pharmacokinetics, Pharmacodynamics, and Disintegration Time of Vaginal Tablets Containing Tenofovir and/or Emtricitabine NCT01694407 · started 2013 · scored riskier than 5% 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.