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Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leiomyoma

Intervention: Vilaprisan (BAY1002670) (Drug); Vilaprisan (BAY1002670 (Drug); Vilaprisan (BAY1002670 (Drug); Vilaprisan (BAY1002670) (Drug); Ulipristal (Drug); Ulipristal (Drug); Ulipristal (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Amenorrhea (yes/no)

Secondary outcome:

Number of bleeding days

Time to onset of controlled bleeding

Percent change in volume of largest fibroid from baseline to end of treatment

Endometrial histology

Endometrial thickness measured by transvaginal ultrasound

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Women, 18 to 50 years of age at the time of screening

- Diagnosis of uterine fibroid(s) documented by trans vaginal 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.

- Eligible to undergo surgical treatment for uterine fibroids at the end of study

treatment

- 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 non hormonal 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 (subjects with hemoglobin values - Women with bleeding/spotting episodes lasting longer than 10 days should not be

included.

- 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.

Locations and Contacts

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Wien 1090, Austria; Recruiting

Bruxelles - Brussel 1000, Belgium; Not yet recruiting

Edegem 2650, Belgium; Not yet recruiting

Pleven 5800, Bulgaria; Not yet recruiting

Sofia 1504, Bulgaria; Not yet recruiting

Sofia 1606, Bulgaria; Terminated

Stara Zagora 6000, Bulgaria; Not yet recruiting

Brno 625 00, Czech Republic; Not yet recruiting

Ceske Budejovice 37001, Czech Republic; Not yet recruiting

Olomouc 772 00, Czech Republic; Recruiting

Olomouc 775 20, Czech Republic; Not yet recruiting

Pisek 39701, Czech Republic; Recruiting

Plzen 30708, Czech Republic; Not yet recruiting

Praha 2 120 00, Czech Republic; Not yet recruiting

Praha 8 180 81, Czech Republic; Not yet recruiting

Praha 13000, Czech Republic; Not yet recruiting

Helsinki 00610, Finland; Not yet recruiting

Pori 28500, Finland; Not yet recruiting

Turku 20100, Finland; Not yet recruiting

Berlin 10787, Germany; Not yet recruiting

Budapest 1036, Hungary; Not yet recruiting

Debrecen 4012, Hungary; Recruiting

Debrecen 4032, Hungary; Not yet recruiting

Szentes H-6600, Hungary; Not yet recruiting

Catania 95123, Italy; Not yet recruiting

Modena 41124, Italy; Recruiting

Vilnius LT-05263, Lithuania; Not yet recruiting

Vilnius LT-08217, Lithuania; Not yet recruiting

Vilnius LT-10207, Lithuania; Not yet recruiting

Almere 1315 RA, Netherlands; Not yet recruiting

Heerlen 6419 PC, Netherlands; Not yet recruiting

Nieuwegein 3435 CM, Netherlands; Not yet recruiting

Zwolle 8025 AB, Netherlands; Not yet recruiting

Fredrikstad 1605, Norway; Not yet recruiting

Lørenskog 1478, Norway; Not yet recruiting

Nesttun 5221, Norway; Not yet recruiting

Stavanger 4011, Norway; Not yet recruiting

Bialystok 15- 224, Poland; Recruiting

Lodz 90-602, Poland; Not yet recruiting

Lublin 20-093, Poland; Not yet recruiting

Lublin 20-632, Poland; Not yet recruiting

Warszawa 02-507, Poland; Not yet recruiting

Coimbra 3000-075, Portugal; Not yet recruiting

Lisboa 1449-005, Portugal; Not yet recruiting

Porto 4202-451, Portugal; Not yet recruiting

Barcelona 08003, Spain; Not yet recruiting

Valencia 46010, Spain; Not yet recruiting

Valencia 46026, Spain; Not yet recruiting

Stockholm 118 83, Sweden; Not yet recruiting

Stockholm 171 76, Sweden; Recruiting

Umeå 90185, Sweden; Not yet recruiting

London N19, United Kingdom; Not yet recruiting

Nottingham NG7 2UH, United Kingdom; Not yet recruiting

Portsmouth PO6 3LY, United Kingdom; Not yet recruiting

Monserrato, Cagliari 09042, Italy; Not yet recruiting

Villach, Kärnten 9500, Austria; Terminated

Harrow, London HA1 3UJ, United Kingdom; Not yet recruiting

Aravaca, Madrid 28023, Spain; Not yet recruiting

Dresden, Sachsen 01307, Germany; Not yet recruiting

Bernburg, Sachsen-Anhalt 06406, Germany; Recruiting

Blankenburg, Sachsen-Anhalt 38889, Germany; Recruiting

Graz, Steiermark 8036, Austria; Not yet recruiting

Innsbruck, Tirol 6020, Austria; Not yet recruiting

Tienen, Vlaams Brabant 3300, Belgium; Not yet recruiting

Additional Information

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Starting date: June 2015
Last updated: August 3, 2015

Page last updated: August 20, 2015

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