Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)

Phase 3

Terminated

• Conditions: Uterine Fibroids
• Interventions: Drug: Vilaprisan (BAY1002670); Drug: Placebo

• Registration Number: NCT03400956
• Lead Sponsor: Bayer

Brief Summary

The primary objective of this study was to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-05
• Study First Submitted QC: 2018-01-15
• Study First Posted: 2018-01-17
• Study Start: 2018-01-24
• Primary Completion: 2019-03-23
• Disposition First Submitted: 2020-03-17
• Disposition First Submitted QC: 2020-03-31
• Disposition First Posted: 2020-04-06
• Results First Submitted: 2021-03-24
• Results First Submitted QC: 2021-04-28
• Results First Posted: 2021-04-30
• Study Completion: 2021-06-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 103

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 more than 30 mm and less than 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 the 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 months since delivery, abortion, or lactation before start of treatment)
• Hypersensitivity to any ingredient of the study drug
• Hemoglobin values ≤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values ≤10.9 g/dL will be recommended to use iron supplementation)
• 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 (e.g. laxatives)
• Use of other treatments that might interfere with the conduct of the study or the interpretation of results
• Undiagnosed abnormal genital bleeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vilaprisan+Placebo (B2)	Vilaprisan (BAY1002670)	Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Placebo+Vilaprisan (B1)	Placebo	Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Vilaprisan (A1)	Vilaprisan (BAY1002670)	Vilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Placebo+Vilaprisan (B1)	Vilaprisan (BAY1002670)	Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Vilaprisan+Placebo (B2)	Placebo	Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Amenorrhea	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. The evaluation of MBL was based on the Alkaline hematin (AH) method.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Heavy Menstrual Bleeding (HMB) Response	The last 28 days of treatment period 1 and treatment period 2	HMB was defined as MBL \<80.00 mL during the last 28 days of treatment and \>50% reduction compared to baseline (assessed by the AH method).
Number of Participants by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)	Up to 36 weeks	Number of participants with endometrial histology findings, e.g. benign endometrium, malignant neoplasm, hyperplasia without atypia, hyperplasia with atypia and endometrial polyps.
Change From Baseline of Endometrial Thickness	In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)	Ultrasound examinations were performed. Endometrial thickness was measured in the medio-sagittal section as double-layer in millimeters. Summary statistics for change from baseline in endometrial thickness was provided in below table.
Time to Onset of Amenorrhea	In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)	Onset of amenorrhea was defined by the first day for which the MBL for all subsequent 28-day periods up to the end of a treatment period was \<2 mL (amenorrhea defined similar to primary endpoint and assessed by the AH method).
Time to Onset of Controlled Bleeding	In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)	Onset of controlled bleeding was defined by the first day for which the MBL for all subsequent 28-day periods up to the end of a treatment period was \<80.00 mL (assessed by the AH method).
Number of Participants With Absence of Bleeding (Spotting Allowed)	The last 28 days of treatment period 1 and treatment period 2	Absence of bleeding was defined as no scheduled or unscheduled bleeding (spotting allowed) during the last 28 days of a treatment period based on subjects' daily responses to the UF-DBD (Uterine Fibroid Daily Bleeding Diary).

Trial Locations

Locations (85)

Clearview Medical Research, LLC; 🇺🇸 Canyon Country, California, United States

Diagnamics, Inc.; 🇺🇸 Encinitas, California, United States

National Research Institute; 🇺🇸 Panorama City, California, United States

Grossmont Center for Clinical Research; 🇺🇸 La Mesa, California, United States

West Coast OB/GYN Associates; 🇺🇸 La Mesa, California, United States

Artemis Institute for Clinical Research; 🇺🇸 San Diego, California, United States

Medical Center for Clinical Research; 🇺🇸 San Diego, California, United States

Women's Medical Research Group, LLC; 🇺🇸 Clearwater, Florida, United States

Vital Pharma Research; 🇺🇸 Hialeah, Florida, United States

Solutions Through Advanced Research, Inc.; 🇺🇸 Jacksonville, Florida, United States

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