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

• ClinicalTrials.gov Identifier: NCT03699176
• Recruitment Status: Withdrawn
• First Posted: October 9, 2018
• Last Update Posted: January 18, 2020
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT03699176
• Other Study ID Numbers: 19434
• First Posted: October 9, 2018
• Last Update Posted: January 18, 2020
• Last Verified: January 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Leiomyoma; Myofibroma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Connective Tissue Diseases