Study of Oxytocin to Treat Vaginal Atrophy in Postmenopausal Women
Model scores of the 29,894 trials active now.
Model score 8% 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 (1,304 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 2011-06-30, after 2010-08-31 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 2011-06-30. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: cellsbreasteffectswomenconcurrent
Phrases that lowered it: screeningtopicalsubjectsto investigateexamination -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Minimum age: 40 (lowers risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Responsible party: not given (raises risk) · Design
-
Drug's FAERS reports with a death: 6.6% (lowers risk) · Drug's FDA history
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
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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Blinding: double (raises risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Disease area, neurology: No (lowers risk) · Disease area
-
Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
-
Number of arms: 2 (raises risk) · Design
-
Drug's FAERS reports marked serious: 84.3% (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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 40 (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
- industry (typical: academic or other)
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 364 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 77 (typical: 412.5)
- Drug's FAERS reports marked serious
- 84.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- oxytocin
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
- Dose-relationship of Vaginally Administrated Oxytocin in Postmenopausal Women NCT01987804 · started 2012 · scored riskier than 6% of active trials completed
- An Efficacy Study of Vagitocin in Postmenopausal Women With Symptoms of Vaginal Atrophy NCT02497547 · started 2014 · scored riskier than 7% of active trials completed
- Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis NCT03294538 · started 2016 · scored riskier than 5% of active trials completed
- Study to Determine Efficacy & Safety of a Low Concentration Estriol (0.005%) in Postmenopausal Vaginal Atrophy. NCT04574999 · started 2008 · scored riskier than 9% of active trials completed
- Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman NCT05627791 · started 2022 · scored riskier than 6% of active trials terminated
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.