NCT03699176

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

8 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

October 27, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

October 5, 2018

Last Update Submit

January 15, 2020

Conditions

Uterine Fibroids

Outcome Measures

Primary Outcomes (1)

  • Amenorrhea (yes/no)

    Defined as menstrual blood loss (MBL) \<2 mL (based on menstrual pictogram)

    Up to 24 weeks (The last 28 days of treatment period 2)

Secondary Outcomes (6)

  • Heavy menstrual bleeding (HMB) response (yes/no)

    Up to 24 weeks (the last 28 days of treatment period 2)

  • Time to onset of amenorrhea

    Up to 24 weeks

  • Time to onset of controlled bleeding

    Up to 24 weeks

  • Absence of bleeding (spotting allowed) based on the Uterine Fibroid Daily Bleeding Diary (UF-DBD)

    Up to 24 weeks (the last 28 days of treatment period 2)

  • Endometrial histology (eg, benign endometrium, presence or absence of hyperplasia or malignancy)

    Up to 36 weeks

  • +1 more secondary outcomes

Study Arms (2)

Vilaprisan

EXPERIMENTAL

2 treatment periods of 12 weeks without a break

Drug: Vilaprisan (BAY1002670)

Placebo

PLACEBO COMPARATOR

2 treatment periods of 12 weeks without a break

Drug: Placebo

Interventions

Vilaprisan (BAY1002670)DRUG

2 mg, once daily, oral

Vilaprisan
PlaceboDRUG

Once daily, oral

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Funabashi Municipal Medical Center

Funabashi, Chiba, 273-8588, Japan

Location

Matsudo City General Hospital

Matsudo, Chiba, 270-2296, Japan

Location

Ena Odori Clinic

Sapporo, Hokkaido, 060-0001, Japan

Location

Tokeidai Memorial Clinic

Sapporo, Hokkaido, 060-0031, Japan

Location

Asahi clinic

Takamatsu, Kagawa-ken, 760-0076, Japan

Location

Kagawa Prefectural Central Hospital

Takamatsu, Kagawa-ken, 760-8557, Japan

Location

Unoki Clinic

Kagoshima, 892-0826, Japan

Location

Japanese Red Cross Kumamoto Hospital

Kumamoto, 861-8520, Japan

Location

MeSH Terms

Conditions

Leiomyoma

Interventions

vilaprisan

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2018

First Posted

October 9, 2018

Study Start

October 27, 2018

Primary Completion

December 25, 2019

Study Completion

December 25, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

JP(8)