Clinical trial NCT02465814: Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids
Official title: A Randomized, Parallel-group, Double-blind Placebo-controlled and Open Label Active Controlled, Multi-center Study to Assess the Efficacy and Safety of Vilaprisan in Patients With Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leiomyoma
Keywords: Uterine fibroids
Heavy Menstrual Bleeding
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-06-09
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is performed to assess the efficacy of Vilaprisan (BAY1002670) in patients with uterine fibroids compared to placebo and ulipristal. It is also aimed to evaluate the safety of vilaprisan in subjects with uterine fibroids. Further, data on population pharmacokinetic (PK)/ pharmacodynamic (PD) relationship for vilaprisan in subjects with uterine fibroids will be supplemented.


Eligibility criteria: Inclusion Criteria:

* Women, 18 to 50 years of age at the time of screening
* Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter \>/=3.0 cm
* Heavy menstrual bleeding (HMB) \>80 mL documented by menstrual pictogram (MP) in a bleeding episode during the screening period. Women who did not suffer from perceived HMB during the 3 months prior to Visit 1 due to any effective medical treatment, e.g. with a hormonal contraceptive, are not considered appropriate candidates and should not undergo further screening procedures. Women suffering from perceived HMB despite medical treatment, e.g. with a hormonal contraceptive, are appropriate candidates for further screening, if rules on stopping prior medication are followed. Heavy menstrual bleeding /HMB) \> 80 mL should be documented within 10 consecutive days.
* Good general health (except for findings related to uterine fibroids) as proven by medical history, physical and gynecological examinations, and laboratory test results
* Normal or clinically insignificant cervical smear not requiring further follow-up. Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASCUS) can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains.
* An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology.
* Use of an acceptable nonhormonal method of contraception (i.e. either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at the bleeding episode following the screening visit 1 (Visit 1) until the end of the study. This is not required if safe contraception is achieved by a permanent method, such as bilateral fallopian tube blockage of the subject or vasectomy of the partner(s).

Exclusion Criteria:

* Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
* Uterine fibroid with largest diameter \>10.0 cm
* 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 offered iron supplementation).
* Any diseases or conditions 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
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
* Abuse of alcohol, drugs, or medicines (e.g. laxatives)
* Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
* Undiagnosed abnormal genital bleeding.

Primary outcomes:
measure: Amenorrhea (yes/no)
timeFrame: From day 7 to day 84 of treatment.
Secondary outcomes:
measure: Number of bleeding days
timeFrame: Up to 32 weeks
measure: Time to onset of controlled bleeding
timeFrame: Up to 28 weeks
measure: Percent change in volume of largest fibroid from baseline to end of treatment.
timeFrame: Baseline and up to 28 weeks
measure: Endometrial histology
timeFrame: Baseline and up to 40 weeks
measure: Endometrial thickness measured by transvaginal ultrasound.
timeFrame: Baseline and up to 40 weeks
Other outcomes:
Locations:
city: Villach
country: Austria
state: Kärnten
city: Graz
country: Austria
state: Steiermark
city: Innsbruck
country: Austria
state: Tirol
city: Wien
country: Austria
city: Tienen
country: Belgium
state: Vlaams Brabant
city: Bruxelles - Brussel
country: Belgium
city: Edegem
country: Belgium
city: Pleven
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Stara Zagora
country: Bulgaria
city: Brno
country: Czech Republic
city: Ceske Budejovice
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Pisek
country: Czech Republic
city: Plzen
country: Czech Republic
city: Praha 2
country: Czech Republic
city: Praha 8
country: Czech Republic
city: Praha
country: Czech Republic
city: Helsinki
country: Finland
city: Pori
country: Finland
city: Turku
country: Finland
city: Bernburg
country: Germany
state: Sachsen-Anhalt
city: Blankenburg
country: Germany
state: Sachsen-Anhalt
city: Dresden
country: Germany
state: Sachsen
city: Berlin
country: Germany
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Debrecen
country: Hungary
city: Szentes
country: Hungary
city: Modena
country: Italy
state: Emilia-Romagna
city: Cagliari
country: Italy
state: Sardegna
city: Catania
country: Italy
state: Sicilia
city: Vilnius
country: Lithuania
city: Vilnius
country: Lithuania
city: Vilnius
country: Lithuania
city: Almere
country: Netherlands
city: Heerlen
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Zwolle
country: Netherlands
city: Fredrikstad
country: Norway
city: Lørenskog
country: Norway
city: Nesttun
country: Norway
city: Stavanger
country: Norway
city: Bialystok
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Lublin
country: Poland
city: Warszawa
country: Poland
city: Coimbra
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Aravaca
country: Spain
state: Madrid
city: Barcelona
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
city: Umeå
country: Sweden
city: Harrow
country: United Kingdom
state: London
city: London
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Portsmouth
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Gemzell-Danielsson K, Heikinheimo O, Zatik J, Poka R, Rechberger T, Hudecek R, Petersdorf K, Ramirez F, Faustmann T, Groettrup-Wolfers E, Seitz C. Efficacy and safety of vilaprisan in women with uterine fibroids: Data from the phase 2b randomized controlled trial ASTEROID 2. Eur J Obstet Gynecol Reprod Biol. 2020 Sep;252:7-14. doi: 10.1016/j.ejogrb.2020.05.043. Epub 2020 May 31.