Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 7)

A Randomized, Parallel-group, Double-blind Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids

The primary objective of this study is 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 are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.

Study Overview

• Status: Withdrawn
• Conditions: Uterine Fibroids
• Intervention / Treatment: Drug: Vilaprisan (BAY1002670); Drug: Placebo

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Kagoshima, Japan, 892-0826
    • Unoki Clinic
  • Kumamoto, Japan, 861-8520
    • Japanese Red Cross Kumamoto Hospital
  • Chiba
    • Funabashi, Chiba, Japan, 273-8588
      • Funabashi Municipal Medical Center
    • Matsudo, Chiba, Japan, 270-2296
      • Matsudo City General Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-0001
      • Ena Odori Clinic
    • Sapporo, Hokkaido, Japan, 060-0031
      • Tokeidai Memorial Clinic
  • Kagawa
    • Takamatsu, Kagawa, Japan, 760-8557
      • Kagawa Prefectural Central Hospital
    • Takamatsu, Kagawa, Japan, 760-0076
      • Asahi Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women, 18 years or older at the time of Visit 1
• Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter of ≥ 30 mm (alternatively, of 30 mm or more)
• 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 menstrual pictogram (MP)
• Use of an acceptable non-hormonal method of contraception
• An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology

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 drugs
• 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 including
• Abuse of alcohol, drugs, or medicines (eg: laxatives)
• Undiagnosed abnormal genital bleeding
• Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vilaprisan; 2 treatment periods of 12 weeks without a break	Drug: Vilaprisan (BAY1002670); 2 mg, once daily, oral
Placebo Comparator: Placebo; 2 treatment periods of 12 weeks without a break	Drug: Placebo; Once daily, oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amenorrhea (yes/no)	Defined as menstrual blood loss (MBL) <2 mL (based on menstrual pictogram)	Up to 24 weeks (The last 28 days of treatment period 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heavy menstrual bleeding (HMB) response (yes/no)	Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline	Up to 24 weeks (the last 28 days of treatment period 2)
Time to onset of amenorrhea	Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2mL.	Up to 24 weeks
Time to onset of controlled bleeding	Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL.	Up to 24 weeks
Absence of bleeding (spotting allowed) based on the Uterine Fibroid Daily Bleeding Diary (UF-DBD)		Up to 24 weeks (the last 28 days of treatment period 2)
Endometrial histology (eg, benign endometrium, presence or absence of hyperplasia or malignancy)		Up to 36 weeks
Endometrial thickness		Up to 36 weeks

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2018
• Primary Completion (Actual): December 25, 2019
• Study Completion (Actual): December 25, 2019

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 5, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 15, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: 19434

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No