Trial · NCT04614246
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
NCT04614246, Phase 2, Terminated, Bayer; results first posted 2023-05-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT04614246. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04614246
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT04614246
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 215 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Endometriosis
- Interventions
- BAY1817080, Elagolix, Placebo
- First posted
- 2020-11-03
- Last updated
- 2023-08-01
- Other registries' IDs
- eudract:2020-003131-16
- Results first posted
- 2023-05-31
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | change from baseline to week 12 | 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 planned on Day 84 \[+3\]). The time frame of 28 days captures a menstrual cycle on average. |
| Secondary | Least Squares Mean (SE) Changes in Worst EAPP From Baseline to Week 12, Per Protocol Set | change from baseline to week 12 | 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 planned on Day 84 \[+3\]). The time frame of 28 days captures a menstrual cycle on average. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAE) | up to 14 days after the last study medication intake | A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | change from baseline to week 12 | The Elagolix arm was not included in the primary per protocol set (pPPS) simply because it's not part of the primary objective which was to assess the dose-response relationship and demonstrate efficacy of BAY 1817080 compared to placebo in women with symptomatic endometriosis. | units on a scale | MEAN |
| SECONDARY | Least Squares Mean (SE) Changes in Worst EAPP From Baseline to Week 12, Per Protocol Set | change from baseline to week 12 | Per protocol set (PPS): includes 183 participants, which is 85.1% of the FAS population. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAE) | up to 14 days after the last study medication intake | Safety analysis set (SAF) includes 190 participants (88.4%) since 25 participants (11.6%) did not receive any study intervention and was excluded from SAF. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group47
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Eliapixant (BAY1817080) 25 mg | Baseline | 6.40 | Standard Deviation 1.66 | units on a scale |
| Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Eliapixant (BAY1817080) 75 mg | Baseline | 6.13 | Standard Deviation 1.77 | units on a scale |
| Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Eliapixant (BAY1817080) 150 mg | Baseline | 6.95 | Standard Deviation 1.38 | units on a scale |
| Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Placebo | Baseline | 6.14 | Standard Deviation 1.96 | units on a scale |
| Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Eliapixant (BAY1817080) 25 mg | Week 12 | 4.57 | Standard Deviation 2.10 | units on a scale |
| Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Eliapixant (BAY1817080) 75 mg | Week 12 | 4.15 | Standard Deviation 2.49 | units on a scale |
| Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Eliapixant (BAY1817080) 150 mg | Week 12 | 5.15 | Standard Deviation 2.42 | units on a scale |
| Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Placebo | Week 12 | 4.29 | Standard Deviation 1.71 | units on a scale |
| Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Eliapixant (BAY1817080) 25 mg | Week 12: Change from Baseline | -1.56 | Standard Deviation 1.35 | units on a scale |
| Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Eliapixant (BAY1817080) 75 mg | Week 12: Change from Baseline | -2.12 | Standard Deviation 2.66 | units on a scale |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Eliapixant (BAY1817080) 25 mg | 44 | |
| Overall Study | STARTED | Eliapixant (BAY1817080) 75 mg | 44 | |
| Overall Study | STARTED | Eliapixant (BAY1817080) 150 mg | 43 | |
| Overall Study | STARTED | Placebo | 43 | |
| Overall Study | STARTED | Elagolix 150mg | 41 | |
| Overall Study | Valid for Safety Analysis Set (SAF) | Eliapixant (BAY1817080) 25 mg | 39 | |
| Overall Study | Valid for Safety Analysis Set (SAF) | Eliapixant (BAY1817080) 75 mg | 38 | |
| Overall Study | Valid for Safety Analysis Set (SAF) | Eliapixant (BAY1817080) 150 mg | 38 | |
| Overall Study | Valid for Safety Analysis Set (SAF) | Placebo | 37 | |
| Overall Study | Valid for Safety Analysis Set (SAF) | Elagolix 150mg | 38 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events685
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Eliapixant (BAY1817080) 25 mg | 0 | 39 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Eliapixant (BAY1817080) 75 mg | 0 | 38 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Eliapixant (BAY1817080) 150 mg | 1 | 38 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 37 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | 150 mg Elagolix | 0 | 38 | 0 |
| other | Coagulopathy | Blood and lymphatic system disorders | Eliapixant (BAY1817080) 25 mg | 0 | 39 | 0 |
| other | Coagulopathy | Blood and lymphatic system disorders | Eliapixant (BAY1817080) 75 mg | 0 | 38 | 0 |
| other | Coagulopathy | Blood and lymphatic system disorders | Eliapixant (BAY1817080) 150 mg | 0 | 38 | 0 |
| other | Coagulopathy | Blood and lymphatic system disorders | Placebo | 1 | 37 | 1 |
| other | Coagulopathy | Blood and lymphatic system disorders | 150 mg Elagolix | 0 | 38 | 0 |
1 to 10 of 685Source ClinicalTrials.gov
See all 685 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Eliapixant (BAY1817080) 25 mg | 0 | 39 |
| Total, all-cause mortality | Eliapixant (BAY1817080) 75 mg | 0 | 38 |
| Total, all-cause mortality | Eliapixant (BAY1817080) 150 mg | 0 | 38 |
| Total, all-cause mortality | Placebo | 0 | 37 |
| Total, all-cause mortality | 150 mg Elagolix | 0 | 38 |
| Total, other adverse events | Eliapixant (BAY1817080) 25 mg | 23 | 39 |
| Total, other adverse events | Eliapixant (BAY1817080) 75 mg | 20 | 38 |
| Total, other adverse events | Eliapixant (BAY1817080) 150 mg | 29 | 38 |
| Total, other adverse events | Placebo | 27 | 37 |
| Total, other adverse events | 150 mg Elagolix | 28 | 38 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04614246
GET https://conductscience.org/api/trials/v1/NCT04614246/results?page=2