The primary objective of this study is to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids compared to ulipristal. The secondary objective of this study is to evaluate the efficacy and safety of different treatment…
ID
Source
Brief title
Condition
- Menstrual cycle and uterine bleeding disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to assess the efficacy of vilaprisan in
subjects with uterine fibroids compared to ulipristal acetate.
Secondary outcome
The secondary objective of this study is to evaluate the efficacy and safety of
different treatment regimens of vilaprisan in subjects with uterine fibroids.
Background summary
The PRM vilaprisan is being tested for the treatment of uterine fibroids. In
two Phase 2 studies, vilaprisan has demonstrated a clinically meaningful
reduction of symptoms associated with uterine fibroids, especially of heavy
menstrual bleeding, improvements of patients* health-related quality of life
and a reduction of fibroid size. Safety data from these studies showed a
favorable safety profile. The active comparator in this study is approved in
the participating countries for the treatment of moderate to severe symptoms of
uterine fibroids.
Study objective
The primary objective of this study is to assess the efficacy and safety of
vilaprisan in subjects with uterine fibroids compared to ulipristal.
The secondary objective of this study is to evaluate the efficacy and safety of
different treatment regimens of vilaprisan in subjects with uterine fibroids.
Study design
Randomized, parallel-group, multi-center design. Screening period of up to 90
days.
Planned to be randomized: 1000 subjects as follows
* Treatment Group A1: 500 subjects
* Treatment Group A2: 500 subjects
Approximately 75% of eligible subjects will be randomized to one of two
vilaprisan treatment groups (Groups A1 or A2) for about one year of treatment
(subgroup 1).
The remaining eligible subjects (about 25%) will be randomized to one of two
vilaprisan treatment groups (Groups A1 or A2) for about 2 years of treatment
(subgroup 2).
In addition 199 subjects have been randomized to Treatment Group A3 or B prior
to implementation of Protocol version 5.0. They will be given the
option to continue in these Treatment Groups with vilaprisan 3/2 being assigned
as medication to both Treatment Groups after implementation of
protocol version 5.0. No new subjects will be randomized in Treatment Group A3
or B after implementation of Protocol version 5.0
Subgroup 1:
o Treatment Group A1: Vilaprisan, 4 treatment periods of 12 weeks, each
separated by 1 bleeding episode (3/1 regimen)
o Treatment Group A2: Vilaprisan, 2 treatment periods of 24 weeks, separated by
2 bleeding episodes (6/2 regimen)
o Treatment Group A3/B: Vilaprisan, 3 treatment periods of 12 weeks, each
separated by 2 bleeding episodes (3/2 regimen)
Subgroup 2:
o Treatment Group A1: Vilaprisan, 8 treatment periods of 12 weeks, each
separated by 1 bleeding episode (3/1 regimen)
o Treatment Group A2: Vilaprisan, 4 treatment periods of 24 weeks, separated by
2 bleeding episodes (6/2 regimen)
Intervention
Subgroup 1:
o Treatment Group A1: Vilaprisan, 4 treatment periods of 12 weeks, each
separated by 1 bleeding episode (3/1 regimen)
o Treatment Group A2: Vilaprisan, 2 treatment periods of 24 weeks, separated by
2 bleeding episodes (6/2 regimen)
o Treatment Group A3/B: Vilaprisan, 3 treatment periods of 12 weeks, each
separated by 2 bleeding episodes (3/2 regimen)
Subgroup 2:
o Treatment Group A1: Vilaprisan, 8 treatment periods of 12 weeks, each
separated by 1 bleeding episode (3/1 regimen)
o Treatment Group A2: Vilaprisan, 4 treatment periods of 24 weeks, separated by
2 bleeding episodes (6/2 regimen)
Study burden and risks
The drug applied in this study has been shown to have a favorable safety
profile. Patients in this study are asked to fill out a daily diary on an
electronic handheld device, including information about sanitary pads or
tampons used on days with menstrual bleeding. Regular visits are scheduled once
every three months of treatment, but due to the intermittent treatment breaks
the actual average time window between visits is longer than three months.
Besides these regular visits, extra visits are scheduled to monitor liver
function. Patients will have to undergo endometrial biopsies with a pipelle de
Cornier at pre-defined scheduled or unscheduled timepoints (up to 4 scheduled
biopsies). 18-21 blood samples are planned in this study and three MRI
examinations. the risk associated with these procedures is low.
Energieweg 1
Mijdrecht 3641 RT
NL
Energieweg 1
Mijdrecht 3641 RT
NL
Listed location countries
Age
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.
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-002855-48-NL |
| CCMO | NL61736.100.17 |