Study Completed

Leiomyoma

Bayer Identifier:

17541

ClinicalTrials.gov Identifier:

NCT02465814

EudraCT Number:

2014-004221-41

EU CT Number:

Not Available

Assess safety and efficacy of vilaprisan in patients with uterine fibroids

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

18 - 50 Years

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 - 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.

Trial summary

Enrollment Goal

120

Trial Dates

June 2015 - October 2016

Phase

Phase 2

Could I Receive a placebo

Products

Vilaprisan (BAY1002670)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Wien, 1090, Austria
Terminated		Innsbruck, 6020, Austria
Completed		Cagliari, 09042, Italy
Completed		Catania, 95123, Italy
Completed		Modena, 41124, Italy
Completed		Aravaca, 28023, Spain
Completed		Barcelona, 08003, Spain
Terminated		Valencia, 46010, Spain
Completed		Valencia, 46026, Spain
Completed		Nesttun, 5221, Norway
Completed		Fredrikstad, 1605, Norway
Completed		Stavanger, 4011, Norway
Terminated		Villach, 9500, Austria
Completed		Bernburg, 06406, Germany
Completed		Blankenburg, 38889, Germany
Terminated		Graz, 8036, Austria
Completed		Nieuwegein, 3435 CM, Netherlands
Terminated		Heerlen, 6419 PC, Netherlands
Completed		ZWOLLE, 8025 AB, Netherlands
Completed		ALMERE, 1315 RA, Netherlands
Completed		Stockholm, 171 76, Sweden
Completed		Stockholm, 118 83, Sweden
Completed		Umeå, 90185, Sweden
Completed		Vilnius, LT-05263, Lithuania
Completed		Vilnius, LT-08217, Lithuania
Completed		Vilnius, LT-10207, Lithuania
Completed		Helsinki, 00610, Finland
Completed		EDEGEM, 2650, Belgium
Completed		BRUXELLES - BRUSSEL, 1000, Belgium
Completed		Pori, 28500, Finland
Completed		Turku, 20100, Finland
Terminated		Nottingham, NG7 2UH, United Kingdom
Terminated		Harrow, HA1 3UJ, United Kingdom
Completed		London, N19 5NF, United Kingdom
Completed		Portsmouth, PO6 3LY, United Kingdom
Completed		Lørenskog, 1478, Norway
Terminated		Dresden, 01307, Germany
Terminated		Berlin, 10787, Germany
Completed		Stara Zagora, 6000, Bulgaria
Completed		Pleven, 5800, Bulgaria
Terminated		Sofia, 1606, Bulgaria
Completed		Sofia, 1504, Bulgaria
Completed		Brno, 625 00, Czech Republic
Terminated		Praha 8, 180 81, Czech Republic
Completed		Pisek, 39701, Czech Republic
Completed		Ceske Budejovice, 37001, Czech Republic
Terminated		Praha, 13000, Czech Republic
Terminated		Olomouc, 775 20, Czech Republic
Completed		Olomouc, 772 00, Czech Republic
Terminated		Praha 2, 120 00, Czech Republic
Completed		Plzen, 30708, Czech Republic
Completed		Lisboa, 1449-005, Portugal
Terminated		Coimbra, 3000-075, Portugal
Completed		Porto, 4202-451, Portugal
Completed		Tienen, 3300, Belgium
Completed		Debrecen, 4032, Hungary
Completed		Debrecen, 4024, Hungary
Completed		Szentes, H-6600, Hungary
Terminated		Budapest, 1036, Hungary
Completed		Lublin, 20-632, Poland
Completed		Bialystok, 15- 224, Poland
Completed		Lublin, 20-093, Poland
Completed		Lodz, 90-602, Poland
Terminated		Warszawa, 02-507, Poland

Primary Outcome

Amenorrhea (yes/no)
Defined as no scheduled or unscheduled bleeding/spotting after end of the initial bleeding episode until the end of the respective treatment period.
Time Frame:
From day 7 to day 84 of treatment.
Safety Issue:
No

Secondary Outcome

Number of bleeding days
Time Frame:
Up to 32 weeks
Safety Issue:
No
Time to onset of controlled bleeding
Time Frame:
Up to 28 weeks
Safety Issue:
No
Percent change in volume of largest fibroid from baseline to end of treatment.
Time Frame:
Baseline and up to 28 weeks
Safety Issue:
No
Endometrial histology
(Frequency of the following categories: benign endometrium, endometrial hyperplasia, malignant neoplasm)
Time Frame:
Baseline and up to 40 weeks
Safety Issue:
Yes
Endometrial thickness measured by transvaginal ultrasound.
Time Frame:
Baseline and up to 40 weeks
Safety Issue:
Yes

Trial design

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 Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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