Bay98-7196, Dose Finding / POC Study | NCT02203331

ID	Type	Description	Link
2013-005090-53	EudraCT Number

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection	Drug: Placebo
Levonorgestrel	Experimental	Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection	Drug: Placebo Drug: Levonorgestrel
Anastrozole 300 µg/d + Levonorgestrel	Experimental	Anastrozole 300 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection	Drug: Placebo Drug: Anastrozole
Anastrozole 600 µg/d + Levonorgestrel	Experimental	Anastrozole 600 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection	Drug: Placebo Drug: Anastrozole
Anastrozole 1050 µg/d + Levonorgestrel	Experimental	Anastrozole 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection	Anastrozole 1050 µg/d + Levonorgestrel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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.	Baseline (last 28 days before randomization), end of treatment (Treatment 3) (last 28 days of the treatment period, Day 57-84)

Secondary Outcomes

Measure	Description	Time Frame
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	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Premenopausal women18 years and above at the time of screening.
Women with endometriosis confirmed by laparoscopy or laparotomy within the last ten years but not less than 8 weeks before the screening visit In Japan, diagnosis based on imaging (transvaginal ultrasound or MRI) also qualifies for inclusion.
Moderate to severe endometriosis-associated pelvic pain (EAPP) of ≥5 in the last 28 days before screening visit 1 measured on the numeric rating scale (NRS; i.e. 4-week recall period).
At randomization: Adherence to the study procedures during the screening period, at least 24 diary entries of ESD item 1 during the last 28 consecutive days before the randomization visit, and a sum of the available ESD item 1 ('worst pain' on the daily NRS) entries during this period of at least 98 (corresponding to an average score of ≥ 3.5).
Willingness to use only ibuprofen as rescue pain medication for EAPP, if needed according to investigator's instruction.
Use of a non-hormonal barrier method (i.e. spermicide-coated condoms) for contraception from screening visit until the end of the study. This is not required if adequate contraception is achieved by vasectomy of the partner

Exclusion Criteria:

Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results.
Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator.
Undiagnosed abnormal genital bleeding
Wish for pregnancy during the study
Regular use of pain medication due to other underlying diseases
Non-responsiveness of endometriosis associated pelvic pain (EAPP) to GnRH-a or surgery (partial response is not exclusionary).

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		San Diego	California	92108	United States

Label	URL
Click here to find information about studies related to Bayer AG products conducted in Europe.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	LNG 40 mcg IVR + Placebo Injection	Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	LNG 40 mcg IVR + Placebo Injection	Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
BG001	ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection	Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
BG002	ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection	Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
BG003	ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection	Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
BG004	Placebo IVR + Leuprorelin Injection	Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
BG005	Placebo IVR + Placebo Injection	Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
BG006	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00033.27± 7.4 BG00132.96± 8.79 BG00233.96± 5.73 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00052 BG00153 BG002

Body Mass Index (BMI)

Mean

Standard Deviation

kilogram per square meter (kg/m^2)

Title

Denominators

Categories

Title	Measurements
	BG00024.19± 4.52 BG00126.07± 6.71 BG002

Mean Pain of the 7 Days With Worst Endometriosis Associated Pelvic Pain (EAPP)

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.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0007.8205± 1.171 BG001

Percentage of Days With Pain Greater Than or Equal to (>=) 7

Higher numbers are associated with more days of pain above the 7 on the 11-point (0-10) NRS.

Mean

Standard Deviation

percentage of days

Title

Denominators

Categories

Title	Measurements
	BG00050.094± 35.5201 BG001

Percentage of Days With Pain >=4

Higher numbers are associated with more days of pain above the 4 on the 11-point (0-10) NRS.

Mean

Standard Deviation

percentage of days

Title

Denominators

Categories

Title	Measurements
	BG00086.0058± 19.3136 BG00184.7239± 18.1713

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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

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.

Posted

Mean

Standard Deviation

units on a scale

Baseline (last 28 days before randomization), end of treatment (Treatment 3) (last 28 days of the treatment period, Day 57-84)

ID	Title	Description
OG000	LNG 40 mcg IVR + Placebo Injection	Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
OG001	ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection	Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
OG002	ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection	Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
OG003	ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection	Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
OG004	Placebo IVR + Leuprorelin Injection	Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
OG005	Placebo IVR + Placebo Injection	Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.

Units	Counts
Participants	OG00039 OG00133 OG00242 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-1.8974± 1.6416(1.6416 to ) OG001-1.6061± 1.6652(1.6652 to ) OG002-2.4014± 2.1833(2.1833 to )

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002 OG003 OG004	The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.	Contrast tests for dose-response model		0.3875		Emax	0.1483	Standard Error of the Mean	0.2925									Superiority or Other (legacy)
OG000 OG001 OG002

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

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.

It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.

Posted

Mean

Standard Deviation

units on a scale

Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56)

ID	Title	Description
OG000	LNG 40 mcg IVR + Placebo Injection	Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
OG001	ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection	Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.

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

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.

It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.

Posted

Mean

Standard Deviation

units on a scale

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)

ID	Title	Description
OG000	LNG 40 mcg IVR + Placebo Injection	Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
OG001	ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection

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

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.

It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.

Posted

Mean

Standard Deviation

percentage of days

Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)

ID	Title	Description
OG000	LNG 40 mcg IVR + Placebo Injection	Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
OG001	ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection	Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.

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

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.

It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.

Posted

Mean

Standard Deviation

percentage of days

Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)

ID	Title	Description
OG000	LNG 40 mcg IVR + Placebo Injection	Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
OG001	ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection	Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.

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

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.

It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.

Posted

Mean

Standard Deviation

percentage of days

Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)

ID	Title	Description
OG000	LNG 40 mcg IVR + Placebo Injection	Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
OG001	ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection	Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.

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

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.

It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.

Posted

Mean

Standard Deviation

percentage of days

Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)

ID	Title	Description
OG000	LNG 40 mcg IVR + Placebo Injection	Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
OG001	ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection	Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	LNG 40 mcg IVR + Placebo Injection	Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.	2	49	38	49
EG001	ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection	Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.	0	50	40	50
EG002	ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection	Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.	0	54	40	54
EG003	ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection	Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.	2	49	35	49
EG004	Placebo IVR + Leuprorelin Injection	Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.	3	50	35	50
EG005	Placebo IVR + Placebo Injection	Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.	4	53	38	53

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pyelonephritis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG0030 affected49 at risk EG0040 affected50 at risk EG0051 affected53 at risk
Pregnancy of unknown location	Pregnancy, puerperium and perinatal conditions	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Renal atrophy	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Endometriosis	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Haemorrhagic ovarian cyst	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Dyshidrotic eczema	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG0030 affected49 at risk EG0040 affected50 at risk EG0051 affected53 at risk
Haemorrhagic disorder	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Lymph node pain	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Extrasystoles	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Deafness transitory	Ear and labyrinth disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Conjunctivitis allergic	Eye disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Eyelid oedema	Eye disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Eyelid rash	Eye disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0021 affected54 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0021 affected54 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0013 affected50 at risk EG0020 affected54 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected49 at risk EG0012 affected50 at risk EG0022 affected54 at risk EG003
Periodontal disease	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Dyschezia	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Noninfectious peritonitis	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Faeces soft	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Asthenia	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Chest pain	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Face oedema	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Fatigue	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0013 affected50 at risk EG0021 affected54 at risk EG003
Feeling hot	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Hunger	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Injection site reaction	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Malaise	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Oedema	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Oedema peripheral	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Pelvic mass	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Pyrexia	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Swelling	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Peripheral swelling	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0021 affected54 at risk EG003
Medical device discomfort	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Haemorrhagic cyst	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Medical device site discomfort	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Bacterial vaginosis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0022 affected54 at risk EG003
Bronchitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0011 affected50 at risk EG0021 affected54 at risk EG003
Cellulitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Cystitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected49 at risk EG0011 affected50 at risk EG0022 affected54 at risk EG003
Ear infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0022 affected54 at risk EG003
Hordeolum	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Influenza	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0012 affected50 at risk EG0020 affected54 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected49 at risk EG0012 affected50 at risk EG0027 affected54 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Periodontitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Pneumonia	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Pulpitis dental	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Sinusitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Tonsillitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0011 affected50 at risk EG0023 affected54 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Urethritis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0012 affected50 at risk EG0022 affected54 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Nail infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Borrelia infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected49 at risk EG0011 affected50 at risk EG0022 affected54 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Arthropod sting	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Epicondylitis	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Bone contusion	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Closed globe injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Activated partial thromboplastin time prolonged	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Alanine aminotransferase abnormal	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0012 affected50 at risk EG0020 affected54 at risk EG003
Aspartate aminotransferase abnormal	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Blood triglycerides increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Colonoscopy	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Blood urine present	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Prothrombin time shortened	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Red blood cells urine positive	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Weight decreased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Weight increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected49 at risk EG0011 affected50 at risk EG0021 affected54 at risk EG003
White blood cells urine positive	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0003 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Urine bilirubin increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Nitrite urine present	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Protein urine present	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Urine ketone body present	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Smear vaginal abnormal	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Gardnerella test positive	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Increased appetite	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected49 at risk EG0012 affected50 at risk EG0020 affected54 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0012 affected50 at risk EG0021 affected54 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Musculoskeletal disorder	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Schwannoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0022 affected54 at risk EG003
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Burning sensation	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Dizziness	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Headache	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0005 affected49 at risk EG0018 affected50 at risk EG0023 affected54 at risk EG003
Migraine	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Neuralgia	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Presyncope	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0012 affected50 at risk EG0021 affected54 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Depression	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Irritability	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Libido decreased	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0021 affected54 at risk EG003
Loss of libido	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Mood altered	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Mood swings	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0011 affected50 at risk EG0022 affected54 at risk EG003
Depressive symptom	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Affect lability	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Amenorrhoea	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Breast cyst	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Breast enlargement	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Breast pain	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected49 at risk EG0012 affected50 at risk EG0021 affected54 at risk EG003
Breast tenderness	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0021 affected54 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Dyspareunia	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Endometriosis	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0003 affected49 at risk EG0012 affected50 at risk EG0023 affected54 at risk EG003
Fibrocystic breast disease	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Galactorrhoea	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Hydrosalpinx	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Hypomenorrhoea	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Menstruation irregular	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0011 affected50 at risk EG0022 affected54 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG00020 affected49 at risk EG00120 affected50 at risk EG00224 affected54 at risk EG003
Ovarian rupture	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0011 affected50 at risk EG0022 affected54 at risk EG003
Polymenorrhoea	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Uterine polyp	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Uterine prolapse	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Vaginal discharge	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0013 affected50 at risk EG0022 affected54 at risk EG003
Vaginal odour	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Varicose veins pelvic	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Vulvovaginal discomfort	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Vulvovaginal dryness	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0021 affected54 at risk EG003
Breast discomfort	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0021 affected54 at risk EG003
Adenomyosis	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Adnexa uteri pain	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Haemorrhagic ovarian cyst	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0012 affected50 at risk EG0020 affected54 at risk EG003
Genital haemorrhage	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0021 affected54 at risk EG003
Uterine haematoma	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Vaginal flatulence	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Vulvovaginal pain	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Abnormal withdrawal bleeding	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0021 affected54 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected49 at risk EG0011 affected50 at risk EG0021 affected54 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected54 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Hand dermatitis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Wisdom teeth removal	Surgical and medical procedures	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Flushing	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Haematoma	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Hot flush	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0023 affected54 at risk EG003
Device breakage	Product Issues	MedDRA (19.1)	Systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected54 at risk EG003
Device expulsion	Product Issues	MedDRA (19.1)	Systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected54 at risk EG003

Ancestor Terms

ID	Term
D009644	Norgestrel
D009652	Norpregnenes
D009650	Norpregnanes
D009654	Norsteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D009570	Nitriles
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D007987	Gonadotropin-Releasing Hormone
D010906	Pituitary Hormone-Releasing Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D009479	Neuropeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D009842	Oligopeptides
D009419	Nerve Tissue Proteins
D011506	Proteins

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases