Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids

Leiomyoma Clinical Trial

— ASTEROID 2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465814
• Other study ID #: 17541
• Secondary ID: 2014-004221-41
• Status: Completed
• Phase: Phase 2
• First received: May 22, 2015
• Last updated: November 21, 2016
• Start date: June 2015
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices AgencyBelgium: Federal Agency for Medicinal Products and Health ProductsBulgaria: Ministry of HealthCzech Republic: State Institute for Drug ControlSpain: Agencia Española de Medicamentos y Productos SanitariosFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesHungary: Ministry of Health, Social and Family AffairsItaly: The Italian Medicines AgencyLithuania: State Medicine Control Agency - Ministry of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Norway: Norwegian Medicines AgencyPoland: Ministry of HealthSweden: Medical Products AgencyPortugal:National Authority of Medicines and Health ProductsUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Leiomyoma

Intervention

Drug:
• Vilaprisan (BAY1002670)
Vilaprisan 2 mg (12 weeks), Vilaprisan 2 mg (12 weeks)
• Vilaprisan (BAY1002670
Placebo (12 weeks),Vilaprisan (12 weeks)
• Vilaprisan (BAY1002670
Vilaprisan 2 mg (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)
• Vilaprisan (BAY1002670)
Placebo (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)
• Ulipristal
Ulipristal 5 mg (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)
• Ulipristal
Placebo (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)
• Ulipristal
Ulipristal (12 weeks), treatment break, Placebo (12 weeks)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Belgium,  Bulgaria,  Czech Republic,  Finland,  Germany,  Hungary,  Italy,  Lithuania,  Netherlands,  Norway,  Poland,  Portugal,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From day 7 to day 84 of treatment.	No
Secondary	Number of bleeding days		Up to 32 weeks	No
Secondary	Time to onset of controlled bleeding		Up to 28 weeks	No
Secondary	Percent change in volume of largest fibroid from baseline to end of treatment.		Baseline and up to 28 weeks	No
Secondary	Endometrial histology	(Frequency of the following categories: benign endometrium, endometrial hyperplasia, malignant neoplasm)	Baseline and up to 40 weeks	Yes
Secondary	Endometrial thickness measured by transvaginal ultrasound.		Baseline and up to 40 weeks	Yes

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