Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)

• Register: ClinicalTrials.gov
• Last refreshed on: 8 May 2023
• Main ID: NCT03400943
• Date of registration: 05/01/2018
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)
• Scientific title: A Randomized, Parallel-group, Double-blind and Open-label Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
• Date of first enrolment: January 17, 2018
• Target sample size: 93
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03400943
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Bulgaria, China, Czechia, Israel, Malaysia, New Zealand, Singapore, South Africa, United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Women, 18 years or older in good General health

- Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1
fibroid with largest Diameter = 30 mm and < 120 mm

- 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 alkaline hematin (AH)
method

- 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 non-hormonal method of contraception (ie, either male condom,
cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1
until the end of the study

Exclusion Criteria:

- Pregnancy or lactation (less than 3 month since delivery, abortion, or lactation
before start of Treatment)

- Hypersensitivity to any ingredient of the study drug

- Any condition requiring immediate blood transfusion

- Laboratory values outside inclusion range before randomization and considered as
clinically relevant.

- 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

- 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 (eg, laxatives)

- Use of other treatments that might interfere with the conduct of the study or the
interpretation of the results

- Undiagnosed abnormal genital bleeding



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Uterine Fibroids

Intervention(s)

Drug: Vilaprisan (BAY1002670)

Drug: Placebo

Primary Outcome(s)

Number of Participants With Amenorrhea [Time Frame: The last 28 days of treatment period 1]

Secondary Outcome(s)

Time to Onset of Controlled Bleeding [Time Frame: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)]

Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) [Time Frame: Up to 2 weeks after end of treatment]

Change From Baseline of Endometrial Thickness [Time Frame: Treatment phase (up to 2 weeks after end of treatment) and follow-up phase (starts on the day after the end of the treatment until the last study visit [up to approximately 2 years])]

Number of Participants With Heavy Menstrual Bleeding (HMB) Response [Time Frame: The last 28 days of treatment period 1 and treatment period 2]

Time to Onset of Amenorrhea [Time Frame: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)]

Number of Participants With Absence of Bleeding (Spotting Allowed) [Time Frame: The last 28 days of treatment period 1 and treatment period 2]

Secondary ID(s)

15787

2017-002997-38

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/06/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03400943