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Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 7)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03699176
Recruitment Status : Withdrawn (No patient was recruited, study withdrawn for feasibility reasons.)
First Posted : October 9, 2018
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Uterine Fibroids Drug: Vilaprisan (BAY1002670) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 27, 2018
Actual Primary Completion Date : December 25, 2019
Actual Study Completion Date : December 25, 2019

Arm Intervention/treatment
Experimental: Vilaprisan
2 treatment periods of 12 weeks without a break
Drug: Vilaprisan (BAY1002670)
2 mg, once daily, oral

Placebo Comparator: Placebo
2 treatment periods of 12 weeks without a break
Drug: Placebo
Once daily, oral




Primary Outcome Measures :
  1. Amenorrhea (yes/no) [ Time Frame: Up to 24 weeks (The last 28 days of treatment period 2) ]
    Defined as menstrual blood loss (MBL) <2 mL (based on menstrual pictogram)


Secondary Outcome Measures :
  1. Heavy menstrual bleeding (HMB) response (yes/no) [ Time Frame: Up to 24 weeks (the last 28 days of treatment period 2) ]
    Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline

  2. Time to onset of amenorrhea [ Time Frame: Up to 24 weeks ]
    Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2mL.

  3. Time to onset of controlled bleeding [ Time Frame: Up to 24 weeks ]
    Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL.

  4. Absence of bleeding (spotting allowed) based on the Uterine Fibroid Daily Bleeding Diary (UF-DBD) [ Time Frame: Up to 24 weeks (the last 28 days of treatment period 2) ]
  5. Endometrial histology (eg, benign endometrium, presence or absence of hyperplasia or malignancy) [ Time Frame: Up to 36 weeks ]
  6. Endometrial thickness [ Time Frame: Up to 36 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699176


Locations
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Japan
Funabashi Municipal Medical Center
Funabashi, Chiba, Japan, 273-8588
Matsudo City General Hospital
Matsudo, Chiba, Japan, 270-2296
Ena Odori Clinic
Sapporo, Hokkaido, Japan, 060-0001
Tokeidai Memorial Clinic
Sapporo, Hokkaido, Japan, 060-0031
Asahi clinic
Takamatsu, Kagawa, Japan, 760-0076
Kagawa Prefectural Central Hospital
Takamatsu, Kagawa, Japan, 760-8557
Unoki Clinic
Kagoshima, Japan, 892-0826
Japanese Red Cross Kumamoto Hospital
Kumamoto, Japan, 861-8520
Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03699176    
Other Study ID Numbers: 19434
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases