Uterine Fibroids
Conditions
Keywords
Uterine Fibroid
Brief summary
The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care
Interventions
2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen).
OTHERStandard of care
Standard of care as determined by the investigators (including watch and wait, symptomatic nonhormonal)
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Diagnosis of uterine fibroid(s) documented by ultrasound at screening AND/OR during a uterine preserving procedure within 3 months prior to screening in subjects with high risk for recurrence * At least one symptom of uterine fibroid(s) - bleeding, pelvic pressure/pain * Good general health * Normal or clinically insignificant cervical smear * An endometrial biopsy performed during the screening period, without significant histological disorder * Use of an acceptable nonhormonal method of contraception starting at Visit 1 until the end of the study
Exclusion criteria
* Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment) * Hypersensitivity to any ingredient of the study drug * Any condition requiring immediate blood transfusion * Any diseases, conditions, or medications 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 * Abuse of alcohol, drugs, or medicines (eg, laxatives) * Use of other treatments that might interfere with the conduct of the study or the interpretation of the results * Undiagnosed abnormal genital bleeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine | From baseline to about 1 year after start of treatment | The percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine from baseline to about one year after start of treatment (SoT) in all randomized and treated participants with measurements at those 2 time points in each treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Bleeding Days | Treatment phase: approximately 1 year | Number of bleeding days were defined from Day 1 of the first treatment period until the day before a new treatment period would start again following the last treatment period for that respective treatment group. Number to be normalized by 28 days |
| Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Up to 3 years (from study treatment start to end of study) | Number of participants with endometrial histology findings, e.g. benign endometrium, presence or absence of hyperplasia or malignancy |
| Change From Baseline in Endometrial Thickness | Treatment phase: approximately 1 year, follow-up phase: up to 2 years | Ultrasound examinations were performed. Endometrial thickness was measured in the medio-sagittal section as double-layer in millimeters. Summary statistics for change from baseline (worst measurement during baseline period) in endometrial thickness was provided in below table. |
| Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Treatment phase: approximately 1 year, follow-up phase: up to 2 years | Percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine (other time points not mentioned as primary safety analysis), hip, and femoral neck from baseline was analyzed using the same statistical methods as used for the primary variable. |
Countries
China, Czechia, Finland, Hong Kong, Japan, Mexico, Norway, Poland, Russia, South Africa, Thailand, Turkey (Türkiye), United States
Participant flow
Recruitment details
The study was conducted at 219 study centers in 13 countries worldwide between 30-Jun-2017 (first participant first visit) and 11-Jul-2024 (last participant last visit).
Pre-assignment details
Overall, 2368 participants were screened. Of the 2368 screened participants, 1096 (46.3%) participants were not randomized to treatment due to screen failures. 1272 (53.7%) participants were randomized and 1238 (52.3%) participants received study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Vilaprisan 2 mg A1 (3/1 Regimen) 4 treatment periods of 12 weeks, each separated by 1 bleeding episode | 361 |
| Vilaprisan 2 mg A2 (6/2 Regimen) 2 treatment periods of 24 weeks, separated by 2 bleeding episodes | 357 |
| Vilaprisan 2 mg A3 (3/2 Regimen) 3 treatment periods of 12 weeks, each separated by 2 bleeding episodes | 181 |
| B (Standard of Care) Standard of care symptomatic nonhormonal medical treatment as determined by the investigators and/or watch and wait | 365 |
| Total | 1,264 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 24 | 25 | 14 | 17 |
| Overall Study | Lack of Efficacy | 4 | 2 | 2 | 12 |
| Overall Study | Lost to Follow-up | 30 | 22 | 12 | 35 |
| Overall Study | Missing | 1 | 0 | 1 | 12 |
| Overall Study | Non-compliance with study drug | 4 | 0 | 1 | 1 |
| Overall Study | Other | 89 | 68 | 34 | 31 |
| Overall Study | Physician Decision | 7 | 9 | 5 | 4 |
| Overall Study | Pregnancy | 4 | 5 | 1 | 2 |
| Overall Study | Protocol Violation | 4 | 2 | 1 | 1 |
| Overall Study | Site terminated by sponsor | 0 | 0 | 2 | 0 |
| Overall Study | Study terminated by sponsor | 62 | 61 | 30 | 34 |
| Overall Study | Withdrawal by Subject | 75 | 74 | 36 | 131 |
Baseline characteristics
| Characteristic | Vilaprisan 2 mg A2 (6/2 Regimen) | Vilaprisan 2 mg A1 (3/1 Regimen) | Total | B (Standard of Care) | Vilaprisan 2 mg A3 (3/2 Regimen) |
|---|---|---|---|---|---|
| Age, Continuous | 41.6 Years STANDARD_DEVIATION 6 | 41.7 Years STANDARD_DEVIATION 5.9 | 41.9 Years STANDARD_DEVIATION 6 | 42.2 Years STANDARD_DEVIATION 6.1 | 41.9 Years STANDARD_DEVIATION 6 |
| Baseline bone mineral density (BMD) of lumbar spine, hip and femoral neck Femoral neck | 0.9174 g/cm^2 STANDARD_DEVIATION 0.1808 | 0.9050 g/cm^2 STANDARD_DEVIATION 0.17 | 0.9090 g/cm^2 STANDARD_DEVIATION 0.1735 | 0.9021 g/cm^2 STANDARD_DEVIATION 0.1703 | 0.9150 g/cm^2 STANDARD_DEVIATION 0.173 |
| Baseline bone mineral density (BMD) of lumbar spine, hip and femoral neck Hip | 1.0044 g/cm^2 STANDARD_DEVIATION 0.1614 | 0.9998 g/cm^2 STANDARD_DEVIATION 0.1528 | 1.0004 g/cm^2 STANDARD_DEVIATION 0.1536 | 0.9944 g/cm^2 STANDARD_DEVIATION 0.1486 | 1.0063 g/cm^2 STANDARD_DEVIATION 0.1508 |
| Baseline bone mineral density (BMD) of lumbar spine, hip and femoral neck Lumbar spine | 1.1653 g/cm^2 STANDARD_DEVIATION 0.1889 | 1.1468 g/cm^2 STANDARD_DEVIATION 0.1869 | 1.1552 g/cm^2 STANDARD_DEVIATION 0.186 | 1.1532 g/cm^2 STANDARD_DEVIATION 0.1851 | 1.1560 g/cm^2 STANDARD_DEVIATION 0.1807 |
| Endometrial thickness | 8.3 Millimeters STANDARD_DEVIATION 4 | 8.3 Millimeters STANDARD_DEVIATION 3.8 | 8.5 Millimeters STANDARD_DEVIATION 4 | 8.7 Millimeters STANDARD_DEVIATION 4.3 | 8.6 Millimeters STANDARD_DEVIATION 3.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 36 Participants | 28 Participants | 114 Participants | 35 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 319 Participants | 330 Participants | 1142 Participants | 327 Participants | 166 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 8 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 6 Participants | 17 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 126 Participants | 124 Participants | 443 Participants | 129 Participants | 64 Participants |
| Race (NIH/OMB) Black or African American | 90 Participants | 99 Participants | 332 Participants | 100 Participants | 43 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 6 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 5 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 129 Participants | 129 Participants | 461 Participants | 132 Participants | 71 Participants |
| Sex: Female, Male Female | 357 Participants | 361 Participants | 1264 Participants | 365 Participants | 181 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 349 | 0 / 347 | 0 / 177 | 0 / 365 | 0 / 349 | 0 / 347 | 0 / 177 | 0 / 365 |
| other Total, other adverse events | 136 / 349 | 152 / 347 | 56 / 177 | 90 / 365 | 75 / 349 | 67 / 347 | 44 / 177 | 14 / 365 |
| serious Total, serious adverse events | 15 / 349 | 17 / 347 | 6 / 177 | 17 / 365 | 54 / 349 | 42 / 347 | 27 / 177 | 7 / 365 |
Outcome results
Primary
Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine
The percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine from baseline to about one year after start of treatment (SoT) in all randomized and treated participants with measurements at those 2 time points in each treatment group.
Time frame: From baseline to about 1 year after start of treatment
Population: Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Overall number of participants analyzed represents number of participants without missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vilaprisan 2 mg A1 (3/1 Regimen) | Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine | -1.56 Percentage change | Standard Deviation 2.72 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine | -2.04 Percentage change | Standard Deviation 2.5 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine | -1.51 Percentage change | Standard Deviation 2.28 |
| B (Standard of Care) | Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine | 0.29 Percentage change | Standard Deviation 2.36 |
95% CI: [-2.44, -1.26]
95% CI: [-2.87, -1.8]
95% CI: [-2.51, -1.1]
Secondary
Change From Baseline in Endometrial Thickness
Ultrasound examinations were performed. Endometrial thickness was measured in the medio-sagittal section as double-layer in millimeters. Summary statistics for change from baseline (worst measurement during baseline period) in endometrial thickness was provided in below table.
Time frame: Treatment phase: approximately 1 year, follow-up phase: up to 2 years
Population: SAF was analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vilaprisan 2 mg A1 (3/1 Regimen) | Change From Baseline in Endometrial Thickness | Baseline | 10.4 Millimeters | Standard Deviation 4 |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Change From Baseline in Endometrial Thickness | Follow up phase (change from baseline) | -0.2 Millimeters | Standard Deviation 5.2 |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Change From Baseline in Endometrial Thickness | Treatment phase (change from baseline) | -0.5 Millimeters | Standard Deviation 5.6 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Change From Baseline in Endometrial Thickness | Treatment phase (change from baseline) | -0.2 Millimeters | Standard Deviation 5.7 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Change From Baseline in Endometrial Thickness | Follow up phase (change from baseline) | -0.3 Millimeters | Standard Deviation 5.7 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Change From Baseline in Endometrial Thickness | Baseline | 10.7 Millimeters | Standard Deviation 4 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Change From Baseline in Endometrial Thickness | Treatment phase (change from baseline) | -0.9 Millimeters | Standard Deviation 4.7 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Change From Baseline in Endometrial Thickness | Baseline | 10.9 Millimeters | Standard Deviation 4 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Change From Baseline in Endometrial Thickness | Follow up phase (change from baseline) | -1.1 Millimeters | Standard Deviation 4.5 |
| B (Standard of Care) | Change From Baseline in Endometrial Thickness | Baseline | 11.0 Millimeters | Standard Deviation 4.4 |
| B (Standard of Care) | Change From Baseline in Endometrial Thickness | Treatment phase (change from baseline) | -0.4 Millimeters | Standard Deviation 4.5 |
| B (Standard of Care) | Change From Baseline in Endometrial Thickness | Follow up phase (change from baseline) | -2.7 Millimeters | Standard Deviation 4.6 |
Secondary
Number of Bleeding Days
Number of bleeding days were defined from Day 1 of the first treatment period until the day before a new treatment period would start again following the last treatment period for that respective treatment group. Number to be normalized by 28 days
Time frame: Treatment phase: approximately 1 year
Population: FAS was analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vilaprisan 2 mg A1 (3/1 Regimen) | Number of Bleeding Days | 1.57 Days | Standard Deviation 1.99 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Number of Bleeding Days | 1.74 Days | Standard Deviation 2.52 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Number of Bleeding Days | 1.81 Days | Standard Deviation 1.24 |
| B (Standard of Care) | Number of Bleeding Days | 4.72 Days | Standard Deviation 4.6 |
Secondary
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Number of participants with endometrial histology findings, e.g. benign endometrium, presence or absence of hyperplasia or malignancy
Time frame: Up to 3 years (from study treatment start to end of study)
Population: SAF was analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vilaprisan 2 mg A1 (3/1 Regimen) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Adequate endometrial tissue | 346 Participants |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Benign Endometrium | 346 Participants |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Hyperplasia WHO 2014, no atypia | 0 Participants |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Hyperplasia WHO 2014, atypia | 0 Participants |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Malignant Neoplasm | 0 Participants |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Endometrial Polyps | 6 Participants |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Endometrial Polyps | 8 Participants |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Hyperplasia WHO 2014, atypia | 0 Participants |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Adequate endometrial tissue | 346 Participants |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Hyperplasia WHO 2014, no atypia | 0 Participants |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Benign Endometrium | 346 Participants |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Malignant Neoplasm | 0 Participants |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Benign Endometrium | 175 Participants |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Hyperplasia WHO 2014, no atypia | 0 Participants |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Hyperplasia WHO 2014, atypia | 0 Participants |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Endometrial Polyps | 4 Participants |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Malignant Neoplasm | 0 Participants |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Adequate endometrial tissue | 175 Participants |
| B (Standard of Care) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Malignant Neoplasm | 0 Participants |
| B (Standard of Care) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Endometrial Polyps | 4 Participants |
| B (Standard of Care) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Benign Endometrium | 359 Participants |
| B (Standard of Care) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Hyperplasia WHO 2014, atypia | 0 Participants |
| B (Standard of Care) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Adequate endometrial tissue | 359 Participants |
| B (Standard of Care) | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Hyperplasia WHO 2014, no atypia | 0 Participants |
Secondary
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
Percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine (other time points not mentioned as primary safety analysis), hip, and femoral neck from baseline was analyzed using the same statistical methods as used for the primary variable.
Time frame: Treatment phase: approximately 1 year, follow-up phase: up to 2 years
Population: SAF was analyzed. Percentage change from baseline in BMD of lumbar spine, hip and femoral neck was presented by time interval in below table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vilaprisan 2 mg A1 (3/1 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Lumbar spine - Month 6 on treatment | -0.18 Percentage change | Standard Deviation 1.7 |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - Month 12 on treatment | -0.84 Percentage change | Standard Deviation 3.42 |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - Month 6 on treatment | -0.71 Percentage change | Standard Deviation 2.69 |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - Month 6 on treatment | -1.00 Percentage change | Standard Deviation 2.89 |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - End of follow up | -0.80 Percentage change | Standard Deviation 3.06 |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Lumbar spine - Month 12 post treatment | -0.10 Percentage change | Standard Deviation 2.81 |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - Month 6 post treatment | -0.87 Percentage change | Standard Deviation 3.45 |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - Month 12 on treatment | -0.84 Percentage change | Standard Deviation 2.19 |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - Month 12 post treatment | -0.72 Percentage change | Standard Deviation 1.95 |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - End of follow up | -0.90 Percentage change | Standard Deviation 4.41 |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Lumbar spine - End of treatment | -1.48 Percentage change | Standard Deviation 2.68 |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - End of treatment | -0.85 Percentage change | Standard Deviation 2.28 |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - Month 12 post treatment | -0.82 Percentage change | Standard Deviation 3.83 |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Lumbar spine - Month 6 post treatment | -0.69 Percentage change | Standard Deviation 3.3 |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - End of treatment | -1.12 Percentage change | Standard Deviation 3.37 |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - Month 6 post treatment | -0.45 Percentage change | Standard Deviation 2.3 |
| Vilaprisan 2 mg A1 (3/1 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Lumbar spine - End of follow up | -0.64 Percentage change | Standard Deviation 4.23 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - Month 6 post treatment | -0.62 Percentage change | Standard Deviation 2.6 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - Month 12 on treatment | -0.64 Percentage change | Standard Deviation 3.45 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - Month 12 post treatment | -0.33 Percentage change | Standard Deviation 1.91 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - End of follow up | -0.09 Percentage change | Standard Deviation 5.16 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - End of follow up | -0.03 Percentage change | Standard Deviation 3.85 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - Month 6 on treatment | 0.66 Percentage change | Standard Deviation 3.27 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - Month 12 post treatment | -1.27 Percentage change | Standard Deviation 3.6 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Lumbar spine - Month 12 post treatment | -0.45 Percentage change | Standard Deviation 3.61 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Lumbar spine - End of follow up | -0.28 Percentage change | Standard Deviation 4.11 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Lumbar spine - End of treatment | -1.76 Percentage change | Standard Deviation 2.64 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - Month 6 post treatment | -0.49 Percentage change | Standard Deviation 3.52 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - Month 6 on treatment | -0.48 Percentage change | Standard Deviation 2.49 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Lumbar spine - Month 6 on treatment | -0.49 Percentage change | Standard Deviation 2.74 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - Month 12 on treatment | -0.99 Percentage change | Standard Deviation 2.23 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - End of treatment | -0.36 Percentage change | Standard Deviation 3.46 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - End of treatment | -0.91 Percentage change | Standard Deviation 2.34 |
| Vilaprisan 2 mg A2 (6/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Lumbar spine - Month 6 post treatment | -0.89 Percentage change | Standard Deviation 2.72 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - End of follow up | -0.20 Percentage change | Standard Deviation 3.81 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Lumbar spine - Month 6 on treatment | 0.51 Percentage change | Standard Deviation 2.52 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Lumbar spine - End of treatment | -1.22 Percentage change | Standard Deviation 2.36 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Lumbar spine - Month 6 post treatment | -0.57 Percentage change | Standard Deviation 2.36 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Lumbar spine - Month 12 post treatment | 0.86 Percentage change | Standard Deviation 2.73 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Lumbar spine - End of follow up | -0.38 Percentage change | Standard Deviation 4.26 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - Month 6 on treatment | 1.54 Percentage change | Standard Deviation 1.21 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - Month 12 on treatment | -0.91 Percentage change | Standard Deviation 2.68 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - End of treatment | -0.61 Percentage change | Standard Deviation 2.63 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - Month 6 post treatment | -0.54 Percentage change | Standard Deviation 3.06 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - Month 12 post treatment | 1.41 Percentage change | Standard Deviation 2.22 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - Month 6 on treatment | 1.23 Percentage change | Standard Deviation 3.08 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - Month 12 on treatment | -0.66 Percentage change | Standard Deviation 3.07 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - End of treatment | -0.42 Percentage change | Standard Deviation 3.21 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - Month 6 post treatment | -0.35 Percentage change | Standard Deviation 3.8 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - Month 12 post treatment | -0.65 Percentage change | Standard Deviation 1.06 |
| Vilaprisan 2 mg A3 (3/2 Regimen) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - End of follow up | -0.52 Percentage change | Standard Deviation 5.7 |
| B (Standard of Care) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - Month 12 on treatment | -0.01 Percentage change | Standard Deviation 3.42 |
| B (Standard of Care) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - End of treatment | -0.06 Percentage change | Standard Deviation 2.65 |
| B (Standard of Care) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - Month 12 on treatment | -0.03 Percentage change | Standard Deviation 2.47 |
| B (Standard of Care) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Lumbar spine - End of treatment | 0.13 Percentage change | Standard Deviation 2.38 |
| B (Standard of Care) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - End of treatment | -0.02 Percentage change | Standard Deviation 3.47 |
| B (Standard of Care) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - Month 6 on treatment | -0.23 Percentage change | Standard Deviation 1.81 |
| B (Standard of Care) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Lumbar spine - End of follow up | -0.07 Percentage change | Standard Deviation 3.49 |
| B (Standard of Care) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Lumbar spine - Month 6 on treatment | -0.88 Percentage change | Standard Deviation 2.6 |
| B (Standard of Care) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - Month 6 post treatment | -0.42 Percentage change | Standard Deviation 3.32 |
| B (Standard of Care) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Lumbar spine - Month 12 post treatment | 1.03 Percentage change | Standard Deviation 6.79 |
| B (Standard of Care) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Lumbar spine - Month 6 post treatment | -0.17 Percentage change | Standard Deviation 2.76 |
| B (Standard of Care) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - End of follow up | 0.08 Percentage change | Standard Deviation 2.91 |
| B (Standard of Care) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - End of follow up | -0.34 Percentage change | Standard Deviation 3.73 |
| B (Standard of Care) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - Month 6 on treatment | 0.08 Percentage change | Standard Deviation 3.8 |
| B (Standard of Care) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - Month 12 post treatment | -0.23 Percentage change | Standard Deviation 3.77 |
| B (Standard of Care) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Hip - Month 6 post treatment | 0.20 Percentage change | Standard Deviation 2.72 |
| B (Standard of Care) | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Femoral neck - Month 12 post treatment | 1.40 Percentage change | Standard Deviation 5.19 |