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NCT04614246 · ClinicalTrials.gov registry record · Phase 2
Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the Womb
A Phase 2 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 2
- Development phase
- 215
- Enrollment target
NCT04614246: Clinical Trial Phase 2 study, sponsored by Bayer.
NCT04614246 is a Phase 2 study that was terminated before completion, run by Bayer. The registered enrollment target is 215 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04614246, a Phase 2 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 215 participants
- Enrollment target
Study Summary
The purpose of this study is to assess safety and efficacy of BAY 1817080 compared to elagolix and placebo in women with symptomatic endometriosis. Study details include: * Study duration: 155 up to 285 days * Treatment duration: 84 days * Visit frequency: 3 laboratory every 2 weeks for participants on BAY 1817080 or placebo
Primary Outcome
The worst EAPP was measured daily on the 0-10 Numerical Rating Scale (NRS) by item 1 of the Endometriosis Symptom Diary (ESD). In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The absolute change in mean worst EAPP was from baseline (last 28 days before the first intake of study drug) to end of intervention (last 28 days ending with the last intake of study drug
Interventions
- DRUG Placebo
- DRUG Elagolix
- DRUG BAY1817080
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2021-01-29 |
| Est. Completion | 2022-05-03 |
| Phase | Phase 2 |
Why NCT04614246 stopped before completion
NCT04614246 is an interventional study that assigns participants to a tested intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04614246 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04614246 about?
NCT04614246 is a clinical study titled "Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the Womb". The purpose of this study is to assess safety and efficacy of BAY 1817080 compared to elagolix and placebo in women with symptomatic endometriosis. Study details include: * Study duration: 155 up to 285 days * Treatment duration: 84 days * Visit frequency: 3 laboratory every 2 weeks for participant...
What is the current status of trial NCT04614246?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 215 participants. The study started on 2021-01-29. Estimated completion is 2022-05-03.
What interventions are being tested in trial NCT04614246?
The interventions under investigation include: Placebo (DRUG), Elagolix (DRUG), BAY1817080 (DRUG).
Who is sponsoring clinical trial NCT04614246?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04614246's enrollment target sits among peer trials
215 289th of 2000 higher than 1,711 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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