Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment
Model scores of the 29,894 trials active now.
Model score 6% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (407 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2021-02-13, after 2018-08-30 start.
Reason given by the sponsor: “other”
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 2021-02-13. 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
-
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Minimum age: 20 (lowers risk) · Who can join
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: womenplaceboacuteactiveatrophy
Phrases that lowered it: paininterfere withdrughealthyphysical -
Phase: 2 (raises risk) · Design
-
Disease area, psychiatry: Yes (raises risk) · Disease area
-
Responsible party: principal investigator (lowers risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Drug's FAERS reports with a death: 12.2% (lowers risk) · Drug's FDA history
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Number of arms: 3 (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Keywords listed: 15 (raises risk) · Design
-
Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 72.4% (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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 15 (typical: 1)
Who can join
- Minimum age
- 20 (typical: 18)
- Maximum age
- 70 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- 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
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 20370 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3763 (typical: 412.5)
- Drug's FAERS reports marked serious
- 72.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry, urogenital
- Drugs matched to FDA substances
- petrolatum, sinecatechins
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
- An Efficacy Study of Vagitocin in Postmenopausal Women With Symptoms of Vaginal Atrophy NCT02497547 · started 2014 · scored riskier than 7% of active trials completed
- Novel Topical Therapies for the Treatment of Genital Pain NCT02099006 · started 2013 · scored riskier than 88% of active trials completed
- Study to Evaluate Efficacy of Vagitocin in Postmenopausal Women With Vulvovaginal Atrophy Symptoms NCT04629885 · started 2016 · scored riskier than 6% of active trials completed
- Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments NCT03844412 · started 2019 · scored riskier than 54% of active trials completed
- Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005%, 0.002%, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women With Vulvovaginal Atrophy NCT02967510 · started 2016 · scored riskier than 9% 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.