A Randomized, Parallel-group, Double-blind and Open-label Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
Overview
- Phase
- Phase 3
- Intervention
- Vilaprisan (BAY1002670)
- Conditions
- Uterine Fibroids
- Sponsor
- Bayer
- Enrollment
- 93
- Locations
- 103
- Primary Endpoint
- Number of Participants With Amenorrhea
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.
The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women, 18 years or older in good General health
- •Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest Diameter ≥ 30 mm and \< 120 mm
- •Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the Screening period each with blood loss volume of \>80.00 mL documented by alkaline hematin (AH) method
- •An endometrial biopsy performed during the Screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology
- •Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study
Exclusion Criteria
- •Pregnancy or lactation (less than 3 month since delivery, abortion, or lactation before start of Treatment)
- •Hypersensitivity to any ingredient of the study drug
- •Any condition requiring immediate blood transfusion
- •Laboratory values outside inclusion range before randomization and considered as clinically relevant.
- •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
Arms & Interventions
Placebo+Vilaprisan (B1)
Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Intervention: Vilaprisan (BAY1002670)
Vilaprisan (A1)
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Intervention: Vilaprisan (BAY1002670)
Vilaprisan (A1)
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Intervention: Placebo
Vilaprisan (A2)
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
Intervention: Vilaprisan (BAY1002670)
Placebo+Vilaprisan (B1)
Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Intervention: Placebo
Vilaprisan+Placebo (B2)
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Intervention: Vilaprisan (BAY1002670)
Vilaprisan+Placebo (B2)
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants With Amenorrhea
Time Frame: The last 28 days of treatment period 1
Amenorrhea was defined as menstrual blood loss (MBL) \<2 mL during the last 28 days of treatment measured by the alkaline hematin (AH) method.
Secondary Outcomes
- Number of Participants With Heavy Menstrual Bleeding (HMB) Response(The last 28 days of treatment period 1 and treatment period 2)
- Time to Onset of Amenorrhea(In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks))
- Number of Participants With Absence of Bleeding (Spotting Allowed)(The last 28 days of treatment period 1 and treatment period 2)
- Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)(Up to 2 weeks after end of treatment)
- Time to Onset of Controlled Bleeding(In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks))
- Change From Baseline of Endometrial Thickness(Treatment phase (up to 2 weeks after end of treatment) and follow-up phase (starts on the day after the end of the treatment until the last study visit [up to approximately 2 years]))