Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

Uterine Fibroids Clinical Trial

— ASTEROID 7  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03699176
• Other study ID #: 19434
• Status: Withdrawn
• Phase: Phase 3
• Start date: October 27, 2018
• Est. completion date: December 25, 2019

Study information

• Verified date: January 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 25, 2019
• Est. primary completion date: December 25, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• Vilaprisan (BAY1002670)
2 mg, once daily, oral
• Placebo
Once daily, oral

Locations

Country	Name	City	State
Japan	Funabashi Municipal Medical Center	Funabashi	Chiba
Japan	Unoki Clinic	Kagoshima
Japan	Japanese Red Cross Kumamoto Hospital	Kumamoto
Japan	Matsudo City General Hospital	Matsudo	Chiba
Japan	Ena Odori Clinic	Sapporo	Hokkaido
Japan	Tokeidai Memorial Clinic	Sapporo	Hokkaido
Japan	Asahi clinic	Takamatsu	Kagawa
Japan	Kagawa Prefectural Central Hospital	Takamatsu	Kagawa

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	Endometrial histology (eg, benign endometrium, presence or absence of hyperplasia or malignancy)		Up to 36 weeks
Secondary	Endometrial thickness		Up to 36 weeks

External Links

•   Click here to find out more about the study and how to participate