Clinical trial NCT03699176: Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
Official title: A Randomized, Parallel-group, Double-blind Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Uterine Fibroids
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-10-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo.The secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.


Eligibility criteria: Inclusion Criteria:

* Women, 18 years or older at the time of Visit 1
* Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter of ≥ 30 mm (alternatively, of 30 mm or more)
* Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of \>80.00 mL documented by the menstrual pictogram (MP)
* Use of an acceptable non-hormonal method of contraception
* An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology

Exclusion Criteria:

* Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
* 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 recommended to use iron supplementation)
* Any diseases, conditions, or medications 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 including
* Abuse of alcohol, drugs, or medicines (eg: laxatives)
* Undiagnosed abnormal genital bleeding
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results

Primary outcomes:
measure: Amenorrhea (yes/no)
timeFrame: Up to 24 weeks (The last 28 days of treatment period 2)
Secondary outcomes:
measure: Heavy menstrual bleeding (HMB) response (yes/no)
timeFrame: Up to 24 weeks (the last 28 days of treatment period 2)
measure: Time to onset of amenorrhea
timeFrame: Up to 24 weeks
measure: Time to onset of controlled bleeding
timeFrame: Up to 24 weeks
measure: Absence of bleeding (spotting allowed) based on the Uterine Fibroid Daily Bleeding Diary (UF-DBD)
timeFrame: Up to 24 weeks (the last 28 days of treatment period 2)
measure: Endometrial histology (eg, benign endometrium, presence or absence of hyperplasia or malignancy)
timeFrame: Up to 36 weeks
measure: Endometrial thickness
timeFrame: Up to 36 weeks
Other outcomes:
Locations:
city: Funabashi
country: Japan
facility: Funabashi Municipal Medical Center
state: Chiba
city: Matsudo
country: Japan
facility: Matsudo City General Hospital
state: Chiba
city: Sapporo
country: Japan
facility: Ena Odori Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Tokeidai Memorial Clinic
state: Hokkaido
city: Takamatsu
country: Japan
facility: Asahi clinic
state: Kagawa
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital
state: Kagawa
city: Kagoshima
country: Japan
facility: Unoki Clinic
city: Kumamoto
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
Study officials:
References: