VILLENDO: Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis

• Sponsor: Bayer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03573336
• Collaborator: (none)
• Enrollment: 8
• Locations: 23
• Arms: 3
• Actual Duration (Months): 28.8
• Patients Per Site: 0.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The primary objective of this study was to assess the efficacy and safety of two doses of vilaprisan compared to placebo in women with symptomatic endometriosis.

The secondary objective of this study was to evaluate the safety and tolerability of two different doses of vilaprisan in women with symptomatic endometriosis.

With the implementation of protocol version 4.0 dated 11-Dec-2018, no new subjects were enrolled. The objectives above cannot be reached as only limited data is available from subjects recruited before the temporary pause.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: Vilaprisan (BAY1002670); Drug: Matching Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Parallel-group, Multicenter Phase 2b Study to Assess the Efficacy and Safety of Two Different Doses of Vilaprisan (BAY1002670) Versus Placebo in Women With Symptomatic Endometriosis
• Actual Study Start Date: Jul 4, 2018
• Actual Primary Completion Date: Mar 18, 2019
• Actual Study Completion Date: Nov 26, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vilaprisan (BAY1002670) 2 mg Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1 Vilaprisan: 2 mg	Drug: Vilaprisan (BAY1002670); Intake orally, once daily
Experimental: Vilaprisan (BAY1002670) 4 mg Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1 Vilaprisan: 4 mg	Drug: Vilaprisan (BAY1002670); Intake orally, once daily
Placebo Comparator: Placebo group Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1	Drug: Matching Placebo; Intake orally, once daily

Outcome Measures

Primary Outcome Measures

1. Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD]) [Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)]

   Pain intensity was assessed on 11-point (0-10) NRS by ESD item 1. In ESD item 1, participants were asked to rate the worst 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. Mean 'worst pelvic pain' was calculated as the sum of the participant's daily assessments of the ESD item 1 ("worst pain" during the last 24 hours) during a study period divided by number of days with pain assessment in that study period. This was summarized by study period. No inferential statistical analysis was performed.

Secondary Outcome Measures

1. Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD]) on Days With/Without Vaginal Bleeding [Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)]

   Pain intensity was assessed on 11-point (0-10) NRS by ESD item 1. In ESD item 1, participants were asked to rate the worst 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. Mean 'worst pelvic pain' on bleeding/non-bleeding days was calculated as the sum of the participant's daily assessments of the ESD item 1 ("worst pain" during the last 24 hours) on bleedings/non-bleeding days during a study period divided by number of bleeding/non-bleeding days with pain assessment in that study period. This was summarized by study period. No inferential statistical analysis was performed.

2. Mean Number of Tablets of Rescue Pain Medication 1 (Ibuprofen 200 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP) [Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)]

   Mean number of tablets of rescue pain medication 1 (Ibuprofen 200 mg) taken daily for EAPP was calculated as the sum of the tablets taken for EAPP during a study period divided by the number of days in that study period. This was summarized by study period. No inferential statistical analysis was performed.

3. Mean Number of Tablets of Rescue Pain Medication 2 (Tramadol 50 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP) [Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)]

   Mean number of tablets of rescue pain medication 2 (Tramadol 50 mg) taken daily for EAPP was calculated as the sum of the tablets taken for EAPP during a study period divided by the number of days in that study period. This was summarized by study period. No inferential statistical analysis was performed.

4. The Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Up to 6 months]

   An adverse event (AE) is any untoward medical occurrence (i.e. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation subject after providing written informed consent for participation in the study. TEAE is defined as AE that is observed or reported after the first administration of study drug or if it starts before the first administration of study drug and the intensity/grade worsens on treatment) in this study.

5. Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings [Up to 6 months]

   Number of participants with endometrial histology findings, e.g. hyperplasia, malignant neoplasm or endometrial polyps

6. Number of Participants With Clinical Significant Abnormal Ultrasound Examinations [Up to 6 months]

   Ultrasound examinations (evaluated for efficacy and safety) will be performed by a qualified expert in performing gynecologic ultrasound exams. If possible, the same examiner should conduct all examinations of a subject throughout the study and the same ultrasound machine (per site) should be used throughout the study. Preferably the safety evaluation should be performed by transvaginal ultrasound (TVU). However, if deemed appropriate, transabdominal or transrectal ultrasound examinations can be performed instead. The chosen method should be used consistently throughout the study.

7. Number of Participants With Clinical Significant Abnormal Bone Mineral Density Measurements [Up to 6 months]

   A Dual-energy X-ray absorptiometry (DEXA) scan of the lumbar spine (lumbar anterior-posterior, L1-L4) and the hip/femoral neck were performed.

8. Number of Participants With Clinical Significant Abnormal Laboratory Values [Up to 6 months]

   Clinical laboratory values including the values of hematology, general chemistry, urinalysis, coagulation, hormones, immunology and vitamins.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Signed and dated informed consent

• Pre-menopausal women 18 years (inclusive) and above at the time of Visit 1

• Women with endometriosis confirmed by laparoscopy or laparotomy OR diagnosed based on imaging

• Moderate to severe endometriosis-associated pelvic pain (EAPP)

• Adherence to screening period diary entries

• Willingness to use only standardized pain medication if needed

• Good general health (except for findings related to endometriosis)

• Normal or clinically insignificant cervical cytology not requiring further follow-up

• An endometrial biopsy performed at the screening phase without significant histological disorder

• Use of an acceptable non-hormonal method of contraception

• Willingness / ability to comply with electronic diary entry for the duration of study participation

Exclusion Criteria:

• Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before Visit 1)

• Hypersensitivity to any ingredient of the study treatments

• Laboratory values outside the inclusion range before randomization, and considered clinically relevant

• 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 including elevated liver enzymes

• Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results

• Undiagnosed abnormal genital bleeding

• Abuse of alcohol, drugs, or medicines (e.g. laxatives) as evaluated by the investigator

• Use of other treatments that might interfere with the conduct of the study or the interpretation of the results

• Endometriosis-specific treatments for symptom relief except rescue pain medication according to protocol

• Simultaneous participation in another clinical trial with investigational medicinal product(s). Participation in another trial prior to study entry that might have an impact on the study objectives, at the discretion of the investigator

• Inability to cooperate with the study procedures for any reason

• Previous assignment to treatment (e.g. randomization) during this study (allowing previously randomized subjects to be re-included into the study may lead to bias)

• Hypersensitivity to any ingredient of standardized pain medication

• Wish for pregnancy during the study

• Regular use of pain medication due to other underlying diseases

• Non-responsiveness of EAPP to GnRH-a (Gonadotropin-releasing hormone agonists)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Office of Dr. James A. Simon, MD	Washington	District of Columbia	United States	20036
2	Helix Biomedics, LLC	Boynton Beach	Florida	United States	33435
3	Solutions Through Advanced Research, Inc.	Jacksonville	Florida	United States	32256
4	Southern Clinical Research Associates LLC	Metairie	Louisiana	United States	70001
5	Unified Women's Clinical Research - Morehead City	Morehead City	North Carolina	United States	28557
6	Unified Women's Clinical Research	Winston-Salem	North Carolina	United States	27103
7	Kepler Universitätsklinikum Campus IV	Linz	Oberösterreich	Austria	4020
8	Medizinische Universität Graz	Graz	Steiermark	Austria	8036
9	KABEG Landeskrankenhaus Villach	Villach		Austria	9500
10	Universitätsklinikum AKH Wien	Wien		Austria	1090
11	Queen's University	Kingston	Ontario	Canada	K7L 2V7
12	Ottawa Hospital-Riverside Campus	Ottawa	Ontario	Canada	K1H 7W9
13	Clinique OVO	Montreal	Quebec	Canada	H4P 2S4
14	Gynekologie MEDA s.r.o.	Brno		Czechia	602 00
15	GynCare MUDr. Michael Svec s.r.o.	Plzen		Czechia	326 00
16	VL-Medi Oy	Helsinki		Finland	00510
17	Satakunnan keskussairaala	Pori		Finland	28500
18	A.O.U.I. Verona	Verona	Veneto	Italy	37126
19	Tokeidai Memorial Clinic	Sapporo	Hokkaido	Japan	060-0031
20	Ishikawa Prefectural Central Hospital	Kanazawa	Ishikawa	Japan	920-8530
21	Japanese Red Cross Kumamoto Hospital	Kumamoto		Japan	861-8520
22	Toyama Prefectural Central Hospital	Toyama		Japan	930-8550
23	Centrum Medyczne Chodzki	Lublin		Poland	20-093

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

• Study Protocol - Feb 17, 2020
• Statistical Analysis Plan - Jan 15, 2020

More Information

Additional Information:

• Click here to find results for studies related to Bayer products
• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT03573336
• Other Study ID Numbers: 15792; 2013-004768-72
• First Posted: Jun 29, 2018
• Last Update Posted: May 4, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Endometriosis

Study Results

Participant Flow

Recruitment Details	Study was conducted at 7 study centers worldwide, between 04-Jul-2018 (first participant first visit) and 26-Nov-2020 (last participant last visit).
Pre-assignment Detail	With the implementation of protocol version 4.0 dated 11-Dec-2018, no new participants were enrolled. The objectives of this study cannot be reached as only limited data is available from participants recruited before the treatment stopped. Overall, 48 participants were screened, of whom 8 participants were randomized and received the study treatment.

Arm/Group Title	Vilaprisan (BAY1002670) 2 mg	Vilaprisan (BAY1002670) 4 mg	Placebo
Arm/Group Description	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg.	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg	Premenopausal women 18 years and older with endometriosis received placebo.
Period Title: Overall Study
STARTED	2	4	2
Treated	2	4	2
COMPLETED	0	0	0
NOT COMPLETED	2	4	2

Baseline Characteristics

Arm/Group Title	Vilaprisan (BAY1002670) 2 mg	Vilaprisan (BAY1002670) 4 mg	Placebo	Total
Arm/Group Description	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg.	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg	Premenopausal women 18 years and older with endometriosis received placebo.	Total of all reporting groups
Overall Participants	2	4	2	8
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	2 100%	4 100%	2 100%	8 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	2 100%	4 100%	2 100%	8 100%
Male	0 0%	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 25%	0 0%	1 12.5%
Not Hispanic or Latino	2 100%	3 75%	2 100%	7 87.5%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	2 100%	4 100%	2 100%	8 100%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD])
Description	Pain intensity was assessed on 11-point (0-10) NRS by ESD item 1. In ESD item 1, participants were asked to rate the worst 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. Mean 'worst pelvic pain' was calculated as the sum of the participant's daily assessments of the ESD item 1 ("worst pain" during the last 24 hours) during a study period divided by number of days with pain assessment in that study period. This was summarized by study period. No inferential statistical analysis was performed.
Time Frame	Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vilaprisan (BAY1002670) 2 mg	Vilaprisan (BAY1002670) 4 mg	Placebo
Arm/Group Description	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg.	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg	Premenopausal women 18 years and older with endometriosis received placebo.
Measure Participants	2	4	2
Screening period	6.0	5.8	5.6
Treatment period	3.0	3.8	5.0

2. Secondary Outcome

Title	Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD]) on Days With/Without Vaginal Bleeding
Description	Pain intensity was assessed on 11-point (0-10) NRS by ESD item 1. In ESD item 1, participants were asked to rate the worst 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. Mean 'worst pelvic pain' on bleeding/non-bleeding days was calculated as the sum of the participant's daily assessments of the ESD item 1 ("worst pain" during the last 24 hours) on bleedings/non-bleeding days during a study period divided by number of bleeding/non-bleeding days with pain assessment in that study period. This was summarized by study period. No inferential statistical analysis was performed.
Time Frame	Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vilaprisan (BAY1002670) 2 mg	Vilaprisan (BAY1002670) 4 mg	Placebo
Arm/Group Description	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg.	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg	Premenopausal women 18 years and older with endometriosis received placebo.
Measure Participants	2	4	2
Screening period: Worst Pain on days with vaginal bleeding	6.5	6.9	7.0
Screening period: Worst Pain on days without vaginal bleeding	5.9	5.5	5.3
Treatment period: Worst Pain on days with vaginal bleeding	NA	5.4	6.0
Treatment period: Worst Pain on days without vaginal bleeding	3.0	3.7	4.7

3. Secondary Outcome

Title	Mean Number of Tablets of Rescue Pain Medication 1 (Ibuprofen 200 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP)
Description	Mean number of tablets of rescue pain medication 1 (Ibuprofen 200 mg) taken daily for EAPP was calculated as the sum of the tablets taken for EAPP during a study period divided by the number of days in that study period. This was summarized by study period. No inferential statistical analysis was performed.
Time Frame	Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vilaprisan (BAY1002670) 2 mg	Vilaprisan (BAY1002670) 4 mg	Placebo
Arm/Group Description	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg.	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg	Premenopausal women 18 years and older with endometriosis received placebo.
Measure Participants	2	4	2
Screening period	0.61	1.01	1.03
Treatment period	0.09	0.16	0.81

4. Secondary Outcome

Title	Mean Number of Tablets of Rescue Pain Medication 2 (Tramadol 50 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP)
Description	Mean number of tablets of rescue pain medication 2 (Tramadol 50 mg) taken daily for EAPP was calculated as the sum of the tablets taken for EAPP during a study period divided by the number of days in that study period. This was summarized by study period. No inferential statistical analysis was performed.
Time Frame	Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vilaprisan (BAY1002670) 2 mg	Vilaprisan (BAY1002670) 4 mg	Placebo
Arm/Group Description	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg.	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg	Premenopausal women 18 years and older with endometriosis received placebo.
Measure Participants	2	4	2
Screening period	0	0	0.17
Treatment period	0.01	0.01	0.02

5. Secondary Outcome

Title	The Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Description	An adverse event (AE) is any untoward medical occurrence (i.e. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation subject after providing written informed consent for participation in the study. TEAE is defined as AE that is observed or reported after the first administration of study drug or if it starts before the first administration of study drug and the intensity/grade worsens on treatment) in this study.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vilaprisan (BAY1002670) 2 mg	Vilaprisan (BAY1002670) 4 mg	Placebo
Arm/Group Description	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg.	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg	Premenopausal women 18 years and older with endometriosis received placebo.
Measure Participants	2	4	2
Non-serious TEAEs	2 100%	3 75%	2 100%
SAEs	1 50%	3 75%	0 0%
Deaths	0 0%	0 0%	0 0%

6. Secondary Outcome

Title	Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings
Description	Number of participants with endometrial histology findings, e.g. hyperplasia, malignant neoplasm or endometrial polyps
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vilaprisan (BAY1002670) 2 mg	Vilaprisan (BAY1002670) 4 mg	Placebo
Arm/Group Description	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg.	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg	Premenopausal women 18 years and older with endometriosis received placebo.
Measure Participants	2	4	2
Endometrial hyperplasia	0 0%	0 0%	0 0%
Malignant neoplasm	0 0%	0 0%	0 0%
Endometrial polyps	0 0%	0 0%	0 0%

7. Secondary Outcome

Title	Number of Participants With Clinical Significant Abnormal Ultrasound Examinations
Description	Ultrasound examinations (evaluated for efficacy and safety) will be performed by a qualified expert in performing gynecologic ultrasound exams. If possible, the same examiner should conduct all examinations of a subject throughout the study and the same ultrasound machine (per site) should be used throughout the study. Preferably the safety evaluation should be performed by transvaginal ultrasound (TVU). However, if deemed appropriate, transabdominal or transrectal ultrasound examinations can be performed instead. The chosen method should be used consistently throughout the study.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vilaprisan (BAY1002670) 2 mg	Vilaprisan (BAY1002670) 4 mg	Placebo
Arm/Group Description	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg.	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg	Premenopausal women 18 years and older with endometriosis received placebo.
Measure Participants	2	4	2
Count of Participants [Participants]	0 0%	0 0%	0 0%

8. Secondary Outcome

Title	Number of Participants With Clinical Significant Abnormal Bone Mineral Density Measurements
Description	A Dual-energy X-ray absorptiometry (DEXA) scan of the lumbar spine (lumbar anterior-posterior, L1-L4) and the hip/femoral neck were performed.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vilaprisan (BAY1002670) 2 mg	Vilaprisan (BAY1002670) 4 mg	Placebo
Arm/Group Description	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg.	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg	Premenopausal women 18 years and older with endometriosis received placebo.
Measure Participants	2	4	2
Count of Participants [Participants]	1 50%	0 0%	0 0%

9. Secondary Outcome

Title	Number of Participants With Clinical Significant Abnormal Laboratory Values
Description	Clinical laboratory values including the values of hematology, general chemistry, urinalysis, coagulation, hormones, immunology and vitamins.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vilaprisan (BAY1002670) 2 mg	Vilaprisan (BAY1002670) 4 mg	Placebo
Arm/Group Description	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg.	Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg	Premenopausal women 18 years and older with endometriosis received placebo.
Measure Participants	2	4	2
Count of Participants [Participants]	0 0%	3 75%	0 0%

Adverse Events

Time Frame	Adverse event data were collected from first study medication intake until last visit of the subject (516 days on average).
Arm/Group Title	Placebo		Vilaprisan (BAY1002670) 2 mg		Vilaprisan (BAY1002670) 4 mg
Arm/Group Description	Premenopausal women 18 years and older with endometriosis received placebo		Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg.		Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg
All Cause Mortality
	Placebo		Vilaprisan (BAY1002670) 2 mg		Vilaprisan (BAY1002670) 4 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/2 (0%)		0/4 (0%)
Serious Adverse Events
	Placebo		Vilaprisan (BAY1002670) 2 mg		Vilaprisan (BAY1002670) 4 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		1/2 (50%)		3/4 (75%)
Eye disorders
Retinal detachment	0/2 (0%)	0	1/2 (50%)	2	0/4 (0%)	0
Infections and infestations
Gastroenteritis	0/2 (0%)	0	0/2 (0%)	0	1/4 (25%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma	0/2 (0%)	0	0/2 (0%)	0	1/4 (25%)	1
Reproductive system and breast disorders
Endometriosis	0/2 (0%)	0	0/2 (0%)	0	1/4 (25%)	1
Surgical and medical procedures
Endometriosis ablation	0/2 (0%)	0	1/2 (50%)	1	0/4 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo		Vilaprisan (BAY1002670) 2 mg		Vilaprisan (BAY1002670) 4 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/2 (100%)		2/2 (100%)		3/4 (75%)
Eye disorders
Dry eye	0/2 (0%)	0	0/2 (0%)	0	1/4 (25%)	1
Gastrointestinal disorders
Diarrhoea	0/2 (0%)	0	0/2 (0%)	0	1/4 (25%)	1
Nausea	1/2 (50%)	1	0/2 (0%)	0	1/4 (25%)	1
Toothache	0/2 (0%)	0	0/2 (0%)	0	1/4 (25%)	3
General disorders
Pyrexia	1/2 (50%)	1	0/2 (0%)	0	0/4 (0%)	0
Infections and infestations
Bronchitis	1/2 (50%)	1	0/2 (0%)	0	0/4 (0%)	0
Fungal skin infection	0/2 (0%)	0	0/2 (0%)	0	1/4 (25%)	1
Gingivitis	0/2 (0%)	0	1/2 (50%)	1	0/4 (0%)	0
Influenza	0/2 (0%)	0	0/2 (0%)	0	1/4 (25%)	2
Nasopharyngitis	0/2 (0%)	0	1/2 (50%)	3	1/4 (25%)	1
Pyelitis	1/2 (50%)	1	0/2 (0%)	0	0/4 (0%)	0
Tonsillitis	1/2 (50%)	1	0/2 (0%)	0	0/4 (0%)	0
Urinary tract infection	0/2 (0%)	0	0/2 (0%)	0	1/4 (25%)	1
Vaginal infection	1/2 (50%)	2	0/2 (0%)	0	0/4 (0%)	0
Vulvovaginal mycotic infection	1/2 (50%)	1	0/2 (0%)	0	0/4 (0%)	0
Injury, poisoning and procedural complications
Procedural pain	0/2 (0%)	0	1/2 (50%)	1	1/4 (25%)	1
Investigations
Cortisol increased	0/2 (0%)	0	0/2 (0%)	0	1/4 (25%)	1
Intraocular pressure increased	0/2 (0%)	0	1/2 (50%)	1	0/4 (0%)	0
Weight increased	0/2 (0%)	0	0/2 (0%)	0	1/4 (25%)	1
Bone density decreased	0/2 (0%)	0	1/2 (50%)	1	0/4 (0%)	0
Metabolism and nutrition disorders
Iron deficiency	0/2 (0%)	0	0/2 (0%)	0	2/4 (50%)	2
Musculoskeletal and connective tissue disorders
Back pain	0/2 (0%)	0	0/2 (0%)	0	1/4 (25%)	2
Bone pain	0/2 (0%)	0	0/2 (0%)	0	1/4 (25%)	1
Nervous system disorders
Headache	2/2 (100%)	20	1/2 (50%)	6	2/4 (50%)	27
Psychiatric disorders
Anxiety	0/2 (0%)	0	0/2 (0%)	0	1/4 (25%)	1
Depressed mood	0/2 (0%)	0	0/2 (0%)	0	1/4 (25%)	1
Mood altered	0/2 (0%)	0	0/2 (0%)	0	1/4 (25%)	1
Adjustment disorder	0/2 (0%)	0	0/2 (0%)	0	1/4 (25%)	1
Reproductive system and breast disorders
Vaginal discharge	1/2 (50%)	1	0/2 (0%)	0	0/4 (0%)	0
Vulvovaginal dryness	0/2 (0%)	0	0/2 (0%)	0	1/4 (25%)	1
Adenomyosis	2/2 (100%)	2	1/2 (50%)	1	0/4 (0%)	0
Skin and subcutaneous tissue disorders
Acne	0/2 (0%)	0	0/2 (0%)	0	2/4 (50%)	2
Hyperhidrosis	1/2 (50%)	1	0/2 (0%)	0	0/4 (0%)	0
Vascular disorders
Hot flush	0/2 (0%)	0	0/2 (0%)	0	1/4 (25%)	2

Limitations/Caveats

No inferential statistical analysis was performed due to a small population.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.