A Phase 3, Randomized, Three-Cycle, Double-Blind, Placebo-Controlled Study to Evaluate Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding for Secondary Amenorrhea

Model scores of the 29,894 trials active now.

Model score 10% for any early termination, 1% 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 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2014-10-31. 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.

• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Design: parallel (raises risk) · Design
• Phase: 3 (lowers risk) · Design
• Drug's FAERS reports with a death: 3.1% (lowers risk) · Drug's FDA history
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: breastestrogendisordercancerrandomization
  Phrases that lowered it: productsopen labelexaminationhealthyperiod
• Has a data monitoring committee: No (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 69.9% (lowers risk) · Drug's FDA history
• Minimum age: 18 (raises risk) · Who can join
• Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
• Blinding: triple (raises risk) · Design
• Number of arms: 3 (lowers risk) · Design
• Responsible party: sponsor (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• 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.

• TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy NCT02449902 · started 2013 · scored riskier than 16% of active trials completed
• A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms NCT01942668 · started 2013 · scored riskier than 16% of active trials completed
• Study Comparing Estradiol Vaginal Inserts 4mcg To IMVEXXY ® (Estradiol Vaginal Inerts 4 mcg) In The Treatment Of Dyspareunia in Women With Vulvur and Vaginal Atrophy NCT05617820 · started 2022 · scored riskier than 6% of active trials completed
• Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo NCT01779947 · started 2012 · scored riskier than 8% of active trials completed
• A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis NCT02195986 · started 2014 · 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.