Overview

This trial has been completed.

Condition leiomyoma
Treatments vilaprisan (bay1002670), vilaprisan (bay1002670, ulipristal
Phase phase 2
Sponsor Bayer
Start date June 2015
End date October 2016
Trial size 120 participants
Trial identifier NCT02465814, 17541, 2014-004221-41

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Vilaprisan (BAY1002670) 2 mg once daily (12 weeks), Vilaprisan 2 mg once daily (12 weeks)
vilaprisan (bay1002670)
Vilaprisan 2 mg (12 weeks), Vilaprisan 2 mg (12 weeks)
(Experimental)
Placebo once daily (12 weeks), Vilaprisan 2 mg once daily (12 weeks)
vilaprisan (bay1002670
Placebo (12 weeks),Vilaprisan (12 weeks)
(Experimental)
Vilaprisan 2 mg once daily (12 weeks), treatment break, Vilaprisan 2 mg once daily (12 weeks)
vilaprisan (bay1002670
Vilaprisan 2 mg (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)
(Experimental)
Placebo once daily (12 weeks), treatment break, Vilaprisan 2 mg once daily(12 weeks)
vilaprisan (bay1002670)
Placebo (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)
(Active Comparator)
Ulipristal 5 mg once daily (12 weeks), treatment break, Ulipristal 5 mg once daily (12 weeks)
ulipristal
Ulipristal 5 mg (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)
(Active Comparator)
Placebo once daily (12 weeks), treatment break, Ulipristal 5 mg once daily (12 weeks)
ulipristal
Placebo (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)
(Active Comparator)
Ulipristal 5 mg once daily (12 weeks), treatment break, Placebo once daily (12 weeks)
ulipristal
Ulipristal (12 weeks), treatment break, Placebo (12 weeks)

Primary Outcomes

Measure
Amenorrhea (yes/no)
time frame: From day 7 to day 84 of treatment.

Secondary Outcomes

Measure
Number of bleeding days
time frame: Up to 32 weeks
Time to onset of controlled bleeding
time frame: Up to 28 weeks
Percent change in volume of largest fibroid from baseline to end of treatment.
time frame: Baseline and up to 28 weeks
Endometrial histology
time frame: Baseline and up to 40 weeks
Endometrial thickness measured by transvaginal ultrasound.
time frame: Baseline and up to 40 weeks

Eligibility Criteria

Female participants from 18 years up to 50 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bayer.