Trial · NCT02203331

Bay98-7196, Dose Finding / POC Study

NCT02203331, Phase 2, Completed, Bayer; results first posted 2018-01-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Bay98-7196, Dose Finding / POC Study. Trials, record NCT02203331. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02203331

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Bay98-7196, Dose Finding / POC Study
NCT number: NCT02203331
Status: Completed
Phases: Phase 2
Enrollment: 319 participants, actual
Lead sponsor: Bayer
Conditions: Endometriosis
Interventions: Placebo, Levonorgestrel, Anastrozole, Lupron / Leuprolide acetate
First posted: 2014-07-29
Last updated: 2023-11-07
Other registries' IDs: eudract:2013-005090-53
Results first posted: 2018-01-04

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD	Baseline (last 28 days before randomization), end of treatment (Treatment 3) (last 28 days of the treatment period, Day 57-84)	Pain intensity was assessed on 11-point (0-10) NRS by question 1. 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 mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.
Secondary	Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment (Day 1-28) and to Second Cycle Under Study Treatment (Day 29-56) as Measured on NRS by Question 1 of ESD	Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56)	Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects 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 mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.
Secondary	Absolute Change in Mean Pain From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment(Day1-28), Second Cycle Under Study Treatment(Day29-56),Third Cycle Under Study Treatment (Day57-84) as Measured on NRS by Question1 of ESD	Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56), and third cycle (Treatment 3) (last 28 days of the treatment period, Day 57-84)	Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects 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 mean pain within a 28-day window was calculated as the sum of ESD item 1 within that 28-day window divided by the number with non-missing days within that 28-day window. Here, number of subjects 'n' signifies evaluable subjects for the respective category.
Secondary	Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain Greater Than or Equal to (>=) 7 as Measured on NRS by Question 1 of ESD as Measured on NRS by Question 1 of ESD	Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)	Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects 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 percentage of days with pain \>=7 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that 28-day window where item 1 of the ESD was \>=7.
Secondary	Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=7 as Measured on NRS by Question 1 of ESD	Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)	Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects 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 percentage of days with pain \>=7 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that 28-day window where item 1 of the ESD was \>=7. Here, number of subjects 'n' signifies evaluable subjects for the respective category.
Secondary	Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain >=4 as Measured on NRS by Question 1 of ESD	Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)	Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects 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 percentage of days with pain \>=4 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that window where Item 1 of the ESD was \>=4. Here, number of subjects 'n' signifies evaluable subjects for the respective category.
Secondary	Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=4 as Measured on NRS by Question 1 of ESD	Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)	Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects 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 percentage of days with pain \>=4 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that window where Item 1 of the ESD was \>=4. Here, number of subjects 'n' signifies evaluable subjects for the respective category.

Source ClinicalTrials.gov

Outcomes7

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 Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD	Baseline (last 28 days before randomization), end of treatment (Treatment 3) (last 28 days of the treatment period, Day 57-84)	The dose-response analysis was performed using the MCP-Mod method with groups containing LNG, ATZ + LNG, and Placebo. It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.	units on a scale	MEAN
SECONDARY	Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment (Day 1-28) and to Second Cycle Under Study Treatment (Day 29-56) as Measured on NRS by Question 1 of ESD	Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56)	It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.	units on a scale	MEAN
SECONDARY	Absolute Change in Mean Pain From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment(Day1-28), Second Cycle Under Study Treatment(Day29-56),Third Cycle Under Study Treatment (Day57-84) as Measured on NRS by Question1 of ESD	Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56), and third cycle (Treatment 3) (last 28 days of the treatment period, Day 57-84)	It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.	units on a scale	MEAN
SECONDARY	Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain Greater Than or Equal to (>=) 7 as Measured on NRS by Question 1 of ESD as Measured on NRS by Question 1 of ESD	Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)	It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.	percentage of days	MEAN
SECONDARY	Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=7 as Measured on NRS by Question 1 of ESD	Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)	It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.	percentage of days	MEAN
SECONDARY	Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain >=4 as Measured on NRS by Question 1 of ESD	Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)	It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.	percentage of days	MEAN
SECONDARY	Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=4 as Measured on NRS by Question 1 of ESD	Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)	It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.	percentage of days	MEAN

Source ClinicalTrials.gov

Results by group114

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 Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD	LNG 40 mcg IVR + Placebo Injection		-1.8974	Standard Deviation 1.6416	units on a scale
Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD	ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection		-1.6061	Standard Deviation 1.6652	units on a scale
Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD	ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection		-2.4014	Standard Deviation 2.1833	units on a scale
Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD	ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection		-2.2653	Standard Deviation 1.5972	units on a scale
Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD	Placebo IVR + Leuprorelin Injection		-3.7679	Standard Deviation 2.3507	units on a scale
Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD	Placebo IVR + Placebo Injection		-2.293	Standard Deviation 1.8247	units on a scale
Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment (Day 1-28) and to Second Cycle Under Study Treatment (Day 29-56) as Measured on NRS by Question 1 of ESD	LNG 40 mcg IVR + Placebo Injection	Change at Treatment 1	-0.7582	Standard Deviation 1.1518	units on a scale
Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment (Day 1-28) and to Second Cycle Under Study Treatment (Day 29-56) as Measured on NRS by Question 1 of ESD	ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection	Change at Treatment 1	-0.6849	Standard Deviation 1.3832	units on a scale
Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment (Day 1-28) and to Second Cycle Under Study Treatment (Day 29-56) as Measured on NRS by Question 1 of ESD	ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection	Change at Treatment 1	-1.1463	Standard Deviation 1.3992	units on a scale
Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment (Day 1-28) and to Second Cycle Under Study Treatment (Day 29-56) as Measured on NRS by Question 1 of ESD	ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection	Change at Treatment 1	-1.0000	Standard Deviation 1.2579	units on a scale

1 to 10 of 114Source ClinicalTrials.gov

See all 114 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	LNG 40 mcg IVR + Placebo Injection	52
Overall Study	STARTED	ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection	53
Overall Study	STARTED	ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection	55
Overall Study	STARTED	ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection	53
Overall Study	STARTED	Placebo IVR + Leuprorelin Injection	53
Overall Study	STARTED	Placebo IVR + Placebo Injection	53
Overall Study	Treated	LNG 40 mcg IVR + Placebo Injection	49
Overall Study	Treated	ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection	50
Overall Study	Treated	ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection	54
Overall Study	Treated	ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection	49

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events1,326

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
other	Anaemia	Blood and lymphatic system disorders	LNG 40 mcg IVR + Placebo Injection	1	49
other	Anaemia	Blood and lymphatic system disorders	ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection	1	50
other	Anaemia	Blood and lymphatic system disorders	ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection	0	54
other	Anaemia	Blood and lymphatic system disorders	ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection	0	49
other	Anaemia	Blood and lymphatic system disorders	Placebo IVR + Leuprorelin Injection	0	50
other	Anaemia	Blood and lymphatic system disorders	Placebo IVR + Placebo Injection	1	53
other	Haemorrhagic disorder	Blood and lymphatic system disorders	LNG 40 mcg IVR + Placebo Injection	0	49
other	Haemorrhagic disorder	Blood and lymphatic system disorders	ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection	0	50
other	Haemorrhagic disorder	Blood and lymphatic system disorders	ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection	0	54
other	Haemorrhagic disorder	Blood and lymphatic system disorders	ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection	1	49

1 to 10 of 1,326Source ClinicalTrials.gov

See all 1,326 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	LNG 40 mcg IVR + Placebo Injection
Total, all-cause mortality	ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection
Total, all-cause mortality	ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection
Total, all-cause mortality	ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection
Total, all-cause mortality	Placebo IVR + Leuprorelin Injection
Total, all-cause mortality	Placebo IVR + Placebo Injection
Total, other adverse events	LNG 40 mcg IVR + Placebo Injection	38	49
Total, other adverse events	ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection	40	50
Total, other adverse events	ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection	40	54
Total, other adverse events	ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection	35	49

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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