Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine Fibroids

• Register: EUCTR
• Last refreshed on: 15 November 2021
• Main ID: EUCTR2016-002855-48-HU
• Date of registration: 03/05/2017
• Prospective Registration: Yes
• Primary sponsor: Bayer AG
• Public title: Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine Fibroids
• Scientific title: A randomized, parallel-group, double-blind, double-dummy, active-controlled, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids - ASTEROID 5
• Date of first enrolment: 04/07/2017
• Target sample size: 996
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002855-48
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Korea, Republic of, Lithuania, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Taiwan, Ukraine, United Kingdom

Contacts

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer AG

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer AG

Key inclusion & exclusion criteria

Inclusion criteria:
1. Women, 18 years or older at the time of Visit 1
2. 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
3. Heavy menstrual bleeding (HMB) >80.0 mL documented by menstrual pictogram (MP) in a bleeding episode period during the screening period
4.Use of an acceptable non-hormonal method of contraception
5. An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 996
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
2. Hypersensitivity to any ingredient of the study drugs
3. 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).
4. 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
5. Abuse of alcohol, drugs, or medicines (eg, laxatives)
6. Undiagnosed abnormal genital bleeding
7. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Leiomyoma
MedDRA version: 19.1 Level: LLT Classification code 10046784 Term: Uterine fibroids System Organ Class: 100000004864
MedDRA version: 19.1 Level: LLT Classification code 10016628 Term: Fibroids System Organ Class: 100000004864
MedDRA version: 19.1 Level: LLT Classification code 10022794 Term: Intramural leiomyoma of uterus System Organ Class: 100000004864

Intervention(s)

Product Name: BAY 1002670 coated tablet 2 mg 245
Product Code: BAY 1002670
Pharmaceutical Form: Coated tablet
INN or Proposed INN: vilaprisan
CAS Number: 1262108-14-4
Current Sponsor code: BAY 1002670
Other descriptive name: BAY 1002670
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use

Trade Name: Esmya 5 mg tablets
Product Name: Esmya 5 mg tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: ulipristal acetate
CAS Number: 126784-99-4
Other descriptive name: ULIPRISTAL ACETATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: The primary objective of this study is to assess the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal.

Primary end point(s): Amenorrhea (yes/no), Defined as menstrual blood loss (MBL) < 2 mL based on the menstrual pictogram (MP) during last 28 days of the treatment period.

Secondary Objective: The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids

Timepoint(s) of evaluation of this end point: At 3 months and 9 months

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1) Amenorrhea At 6 months, at 12 months, at 15 months, at 18 months, at 21 months and at 24 months
2) Absence of bleeding up to 24 months
3) Number of bleeding days from day 1 of the first treatment period until the day before the next treatment period after the last treatment period would start again normalized to 28 days
4) Time to onset of controlled bleeding at quarterly up to 24 months
5) Heavy Menstrual Bleeding responder rate; by treatment period up to 24 months
6) Percent change in volume of largest fibroid compared to baseline at baseline, at 12 months and at 24 months
7) Endometrial histology at baseline, at 12 months and at 24 months
8) Endometrial thickness once per 3-months-treatment period

Secondary end point(s): 1) Amenorrhea (yes/no); Defined as menstrual blood loss (MBL) < 2 mL based on the menstrual pictogram (MP) during last 28 days of the treatment period.
2) Absence of bleeding (yes/no); defined as no bleeding (spotting allowed) during the last 28 days of the treatment; based on the UF-DBD
3) Number of bleeding days;
4) Time to onset of controlled bleeding; Onset of controlled bleeding is defined by the first day, for which the menstrual blood loss (assessed by Menstrual pictogram) is less than 80.0 mL.
5) Heavy Menstrual Bleeding responder rate; Percentage of subjects with blood loss < 80.0 mL and 50% reduction compared to baseline (assessed by Menstrual Pictogram)
6) Percent change in volume of largest fibroid compared to baseline measured by MRI
7) Endometrial histology' Assess benign endometrium, presence or absence of hyperplasia or malignancy
8) Endometrial thickness by ultrasound

Secondary ID(s)

2016-002855-48-IE

BAY1002670/15789

Source(s) of Monetary Support

Bayer AG

Ethics review

Status: Approved
Approval date: 27/06/2017
Contact: