Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine Fibroids

• Register: EUCTR
• Last refreshed on: 13 December 2021
• Main ID: EUCTR2016-002855-48-SE
• Date of registration: 18/04/2017
• 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, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids
• Date of first enrolment: 16/06/2017
• Target sample size: 1200
• 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: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: 3 treatment arms with vilaprisan: A1 - 3/1 regimen; A2 - 6/2 regimen; A3 - 3/2 regimen.; Number of treatment arms in the trial: 3
• 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, Latvia, 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 1200
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
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

Leiomyoma
MedDRA version: 21.1 Level: LLT Classification code 10046784 Term: Uterine fibroids System Organ Class: 100000004864
MedDRA version: 21.1 Level: LLT Classification code 10016628 Term: Fibroids System Organ Class: 100000004864
MedDRA version: 21.1 Level: LLT Classification code 10022794 Term: Intramural leiomyoma of uterus System Organ Class: 100000004864

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

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-

Primary Outcome(s)

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

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

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: For the primary analysis of the primary variable, the amenorrhea rates after 12 weeks of treatment in Groups A1, A2 and A3 will be compared to the rate from Group B .

Secondary Outcome(s)

Secondary end point(s): 1) Total volume of menstrual blood loss (assessed by MP).
2) Number of bleeding days
3) Amenorrhea (yes/no)
4) Absence of bleeding (spotting allowed)
5) Time to onset of controlled bleeding
6) HMB responder rate
7) Percent change in volume of largest fibroid compared to baseline (measured by MRI)

Timepoint(s) of evaluation of this end point: 1) Menstrual blood loss: from Day 1 of the TP1 until the day before a new TP would start again following the last treatment period
2) Number of bleeding days: from Day 1 of the TP1 until the day before a new TP would start again following the last treatment period
3) Amenorrhea (yes/no), defined as MBL < 2 mL during last 28 days of each TP
4) Absence of bleeding during the last 28 days of the treatment
5) Time to onset of controlled bleeding: the first day, for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is less than 80mL.
6) HMB responder rate (Percentage of subjects with blood loss < 80mL per 28 days and 50% reduction compared to baseline
7) Percent change in volume of largest fibroid compared to baseline

Secondary ID(s)

BAY1002670/15789

2016-002855-48-IE

Source(s) of Monetary Support

Bayer AG

Ethics review

Status: Approved
Approval date: 16/06/2017
Contact: