Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

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

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)

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

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.