Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
Model scores of the 29,894 trials active now.
Model score 5% 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 12% of the time (422 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 2011-09-30, after 2008-03-31 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 2011-09-30. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: womentherapyprimaryskinstudy of
Phrases that lowered it: efficacydisordersexualalcoholallergic -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Minimum age: 30 (lowers risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Drug's FAERS reports with a death: 7.0% (lowers risk) · Drug's FDA history
-
Design: parallel (raises risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, psychiatry: Yes (raises risk) · Disease area
-
Sponsor's past trials: 1 (lowers risk) · Sponsor's track record
-
Number of arms: 2 (raises risk) · Design
-
Drug's FAERS reports marked serious: 73.7% (lowers risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 30 (typical: 18)
- Maximum age
- 65 (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
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (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
- 689 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 184 (typical: 412.5)
- Drug's FAERS reports marked serious
- 73.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- testosterone, testosterone propionate
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
- Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women NCT00612742 · started 2008 · scored riskier than 70% of active trials completed
- Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) NCT01235754 · started 2010 · scored riskier than 6% of active trials completed
- A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal) NCT04943068 · started 2021 · scored riskier than 5% of active trials completed
- Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America NCT01057901 · started 2010 · scored riskier than 46% of active trials terminated
- Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women NCT00996372 · started 2009 · scored riskier than 78% 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.