Endometriosis
Conditions
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.
Interventions
Intake orally, once daily
DRUGMatching Placebo
Intake orally, once daily
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
Countries
Austria, Canada, Czechia, Finland, Italy, Japan, Poland, United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Vilaprisan (BAY1002670) 2 mg Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg. | 2 |
| Vilaprisan (BAY1002670) 4 mg Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg | 4 |
| Placebo Premenopausal women 18 years and older with endometriosis received placebo. | 2 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Study terminated | 2 | 4 | 2 |
Baseline characteristics
| Characteristic | Vilaprisan (BAY1002670) 2 mg | Vilaprisan (BAY1002670) 4 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 4 Participants | 2 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 | 0 / 4 |
| other Total, other adverse events | 2 / 2 | 2 / 2 | 3 / 4 |
| serious Total, serious adverse events | 0 / 2 | 1 / 2 | 3 / 4 |
Outcome results
Primary
Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD])
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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Vilaprisan (BAY1002670) 2 mg | Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD]) | Screening period | 6.0 Scores on a scale |
| Vilaprisan (BAY1002670) 2 mg | Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD]) | Treatment period | 3.0 Scores on a scale |
| Vilaprisan (BAY1002670) 4 mg | Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD]) | Screening period | 5.8 Scores on a scale |
| Vilaprisan (BAY1002670) 4 mg | Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD]) | Treatment period | 3.8 Scores on a scale |
| Placebo | Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD]) | Screening period | 5.6 Scores on a scale |
| Placebo | Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD]) | Treatment period | 5.0 Scores on a scale |
Secondary
Mean Number of Tablets of Rescue Pain Medication 1 (Ibuprofen 200 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP)
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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Vilaprisan (BAY1002670) 2 mg | Mean Number of Tablets of Rescue Pain Medication 1 (Ibuprofen 200 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP) | Screening period | 0.61 Tablets |
| Vilaprisan (BAY1002670) 2 mg | Mean Number of Tablets of Rescue Pain Medication 1 (Ibuprofen 200 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP) | Treatment period | 0.09 Tablets |
| Vilaprisan (BAY1002670) 4 mg | Mean Number of Tablets of Rescue Pain Medication 1 (Ibuprofen 200 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP) | Screening period | 1.01 Tablets |
| Vilaprisan (BAY1002670) 4 mg | Mean Number of Tablets of Rescue Pain Medication 1 (Ibuprofen 200 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP) | Treatment period | 0.16 Tablets |
| Placebo | Mean Number of Tablets of Rescue Pain Medication 1 (Ibuprofen 200 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP) | Screening period | 1.03 Tablets |
| Placebo | Mean Number of Tablets of Rescue Pain Medication 1 (Ibuprofen 200 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP) | Treatment period | 0.81 Tablets |
Secondary
Mean Number of Tablets of Rescue Pain Medication 2 (Tramadol 50 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP)
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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Vilaprisan (BAY1002670) 2 mg | Mean Number of Tablets of Rescue Pain Medication 2 (Tramadol 50 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP) | Screening period | 0 Tablets |
| Vilaprisan (BAY1002670) 2 mg | Mean Number of Tablets of Rescue Pain Medication 2 (Tramadol 50 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP) | Treatment period | 0.01 Tablets |
| Vilaprisan (BAY1002670) 4 mg | Mean Number of Tablets of Rescue Pain Medication 2 (Tramadol 50 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP) | Screening period | 0 Tablets |
| Vilaprisan (BAY1002670) 4 mg | Mean Number of Tablets of Rescue Pain Medication 2 (Tramadol 50 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP) | Treatment period | 0.01 Tablets |
| Placebo | Mean Number of Tablets of Rescue Pain Medication 2 (Tramadol 50 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP) | Screening period | 0.17 Tablets |
| Placebo | Mean Number of Tablets of Rescue Pain Medication 2 (Tramadol 50 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP) | Treatment period | 0.02 Tablets |
Secondary
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
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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Vilaprisan (BAY1002670) 2 mg | 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: Worst Pain on days with vaginal bleeding | 6.5 Scores on a scale |
| Vilaprisan (BAY1002670) 2 mg | 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: Worst Pain on days without vaginal bleeding | 5.9 Scores on a scale |
| Vilaprisan (BAY1002670) 2 mg | 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 | Treatment period: Worst Pain on days with vaginal bleeding | NA Scores on a scale |
| Vilaprisan (BAY1002670) 2 mg | 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 | Treatment period: Worst Pain on days without vaginal bleeding | 3.0 Scores on a scale |
| Vilaprisan (BAY1002670) 4 mg | 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 | Treatment period: Worst Pain on days without vaginal bleeding | 3.7 Scores on a scale |
| Vilaprisan (BAY1002670) 4 mg | 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: Worst Pain on days with vaginal bleeding | 6.9 Scores on a scale |
| Vilaprisan (BAY1002670) 4 mg | 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 | Treatment period: Worst Pain on days with vaginal bleeding | 5.4 Scores on a scale |
| Vilaprisan (BAY1002670) 4 mg | 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: Worst Pain on days without vaginal bleeding | 5.5 Scores on a scale |
| Placebo | 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 | Treatment period: Worst Pain on days without vaginal bleeding | 4.7 Scores on a scale |
| Placebo | 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: Worst Pain on days without vaginal bleeding | 5.3 Scores on a scale |
| Placebo | 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 | Treatment period: Worst Pain on days with vaginal bleeding | 6.0 Scores on a scale |
| Placebo | 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: Worst Pain on days with vaginal bleeding | 7.0 Scores on a scale |
Secondary
Number of Participants With Clinical Significant Abnormal Bone Mineral Density Measurements
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vilaprisan (BAY1002670) 2 mg | Number of Participants With Clinical Significant Abnormal Bone Mineral Density Measurements | 1 Participants |
| Vilaprisan (BAY1002670) 4 mg | Number of Participants With Clinical Significant Abnormal Bone Mineral Density Measurements | 0 Participants |
| Placebo | Number of Participants With Clinical Significant Abnormal Bone Mineral Density Measurements | 0 Participants |
Secondary
Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings
Number of participants with endometrial histology findings, e.g. hyperplasia, malignant neoplasm or endometrial polyps
Time frame: Up to 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vilaprisan (BAY1002670) 2 mg | Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings | Malignant neoplasm | 0 Participants |
| Vilaprisan (BAY1002670) 2 mg | Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings | Endometrial hyperplasia | 0 Participants |
| Vilaprisan (BAY1002670) 2 mg | Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings | Endometrial polyps | 0 Participants |
| Vilaprisan (BAY1002670) 4 mg | Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings | Malignant neoplasm | 0 Participants |
| Vilaprisan (BAY1002670) 4 mg | Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings | Endometrial hyperplasia | 0 Participants |
| Vilaprisan (BAY1002670) 4 mg | Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings | Endometrial polyps | 0 Participants |
| Placebo | Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings | Endometrial hyperplasia | 0 Participants |
| Placebo | Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings | Endometrial polyps | 0 Participants |
| Placebo | Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings | Malignant neoplasm | 0 Participants |
Secondary
Number of Participants With Clinical Significant Abnormal Laboratory Values
Clinical laboratory values including the values of hematology, general chemistry, urinalysis, coagulation, hormones, immunology and vitamins.
Time frame: Up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vilaprisan (BAY1002670) 2 mg | Number of Participants With Clinical Significant Abnormal Laboratory Values | 0 Participants |
| Vilaprisan (BAY1002670) 4 mg | Number of Participants With Clinical Significant Abnormal Laboratory Values | 3 Participants |
| Placebo | Number of Participants With Clinical Significant Abnormal Laboratory Values | 0 Participants |
Secondary
Number of Participants With Clinical Significant Abnormal Ultrasound Examinations
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vilaprisan (BAY1002670) 2 mg | Number of Participants With Clinical Significant Abnormal Ultrasound Examinations | 0 Participants |
| Vilaprisan (BAY1002670) 4 mg | Number of Participants With Clinical Significant Abnormal Ultrasound Examinations | 0 Participants |
| Placebo | Number of Participants With Clinical Significant Abnormal Ultrasound Examinations | 0 Participants |
Secondary
The Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vilaprisan (BAY1002670) 2 mg | The Number of Participants With Treatment Emergent Adverse Events (TEAEs) | SAEs | 1 Participants |
| Vilaprisan (BAY1002670) 2 mg | The Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Non-serious TEAEs | 2 Participants |
| Vilaprisan (BAY1002670) 2 mg | The Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Deaths | 0 Participants |
| Vilaprisan (BAY1002670) 4 mg | The Number of Participants With Treatment Emergent Adverse Events (TEAEs) | SAEs | 3 Participants |
| Vilaprisan (BAY1002670) 4 mg | The Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Non-serious TEAEs | 3 Participants |
| Vilaprisan (BAY1002670) 4 mg | The Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Deaths | 0 Participants |
| Placebo | The Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Non-serious TEAEs | 2 Participants |
| Placebo | The Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Deaths | 0 Participants |
| Placebo | The Number of Participants With Treatment Emergent Adverse Events (TEAEs) | SAEs | 0 Participants |