Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids (ASTEROID 2)
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| ClinicalTrials.gov Identifier: NCT02465814 |
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Recruitment Status :
Completed
First Posted : June 9, 2015
Last Update Posted : November 22, 2016
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Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
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Brief Summary:
The study is performed to assess the efficacy of Vilaprisan (BAY1002670) in patients with uterine fibroids compared to placebo and ulipristal. It is also aimed to evaluate the safety of vilaprisan in subjects with uterine fibroids. Further, data on population pharmacokinetic (PK)/ pharmacodynamic (PD) relationship for vilaprisan in subjects with uterine fibroids will be supplemented.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Leiomyoma | Drug: Vilaprisan (BAY1002670) Drug: Vilaprisan (BAY1002670 Drug: Ulipristal | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 120 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 and Open Label Active Controlled, Multi-center Study to Assess the Efficacy and Safety of Vilaprisan in Patients With Uterine Fibroids |
| Study Start Date : | June 2015 |
| Actual Primary Completion Date : | October 2016 |
| Actual Study Completion Date : | October 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm 1 - BAY1002670 + BAY1002670
Vilaprisan (BAY1002670) 2 mg once daily (12 weeks), Vilaprisan 2 mg once daily (12 weeks)
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Drug: Vilaprisan (BAY1002670)
Vilaprisan 2 mg (12 weeks), Vilaprisan 2 mg (12 weeks) |
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Experimental: Arm 2 - Placebo + BAY1002670
Placebo once daily (12 weeks), Vilaprisan 2 mg once daily (12 weeks)
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Drug: Vilaprisan (BAY1002670
Placebo (12 weeks),Vilaprisan (12 weeks) |
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Experimental: Arm 3 - BAY1002670 + BAY1002670
Vilaprisan 2 mg once daily (12 weeks), treatment break, Vilaprisan 2 mg once daily (12 weeks)
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Drug: Vilaprisan (BAY1002670
Vilaprisan 2 mg (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks) |
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Experimental: Arm 4 - Placebo+BAY1002670
Placebo once daily (12 weeks), treatment break, Vilaprisan 2 mg once daily(12 weeks)
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Drug: Vilaprisan (BAY1002670)
Placebo (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks) |
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Active Comparator: Arm 5 - Ulipristal + Ulipristal
Ulipristal 5 mg once daily (12 weeks), treatment break, Ulipristal 5 mg once daily (12 weeks)
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Drug: Ulipristal
Ulipristal 5 mg (12 weeks), treatment break, Ulipristal 5 mg (12 weeks) |
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Active Comparator: Arm 6- Placebo + Ulipristal
Placebo once daily (12 weeks), treatment break, Ulipristal 5 mg once daily (12 weeks)
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Drug: Ulipristal
Placebo (12 weeks), treatment break, Ulipristal 5 mg (12 weeks) |
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Active Comparator: Arm 7- Ulipristal + Placebo
Ulipristal 5 mg once daily (12 weeks), treatment break, Placebo once daily (12 weeks)
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Drug: Ulipristal
Ulipristal (12 weeks), treatment break, Placebo (12 weeks) |
Primary Outcome Measures :
- Amenorrhea (yes/no) [ Time Frame: From day 7 to day 84 of treatment. ]Defined as no scheduled or unscheduled bleeding/spotting after end of the initial bleeding episode until the end of the respective treatment period.
Secondary Outcome Measures :
- Number of bleeding days [ Time Frame: Up to 32 weeks ]
- Time to onset of controlled bleeding [ Time Frame: Up to 28 weeks ]
- Percent change in volume of largest fibroid from baseline to end of treatment. [ Time Frame: Baseline and up to 28 weeks ]
- Endometrial histology [ Time Frame: Baseline and up to 40 weeks ](Frequency of the following categories: benign endometrium, endometrial hyperplasia, malignant neoplasm)
- Endometrial thickness measured by transvaginal ultrasound. [ Time Frame: Baseline and up to 40 weeks ]
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Women, 18 to 50 years of age at the time of screening
- Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter >/=3.0 cm
- Heavy menstrual bleeding (HMB) >80 mL documented by menstrual pictogram (MP) in a bleeding episode during the screening period. Women who did not suffer from perceived HMB during the 3 months prior to Visit 1 due to any effective medical treatment, e.g. with a hormonal contraceptive, are not considered appropriate candidates and should not undergo further screening procedures. Women suffering from perceived HMB despite medical treatment, e.g. with a hormonal contraceptive, are appropriate candidates for further screening, if rules on stopping prior medication are followed. Heavy menstrual bleeding /HMB) > 80 mL should be documented within 10 consecutive days.
- Good general health (except for findings related to uterine fibroids) as proven by medical history, physical and gynecological examinations, and laboratory test results
- Normal or clinically insignificant cervical smear not requiring further follow-up. Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASCUS) can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains.
- 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 nonhormonal method of contraception (i.e. either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at the bleeding episode following the screening visit 1 (Visit 1) until the end of the study. This is not required if safe contraception is achieved by a permanent method, such as bilateral fallopian tube blockage of the subject or vasectomy of the partner(s).
Exclusion Criteria:
- Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
- Uterine fibroid with largest diameter >10.0 cm
- 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 offered iron supplementation).
- Any diseases or conditions 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 (e.g. laxatives)
- Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
- Undiagnosed abnormal genital bleeding.
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): NCT02465814
Locations
Show 64 study locations
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT02465814 |
| Other Study ID Numbers: |
17541 2014-004221-41 ( EudraCT Number ) |
| First Posted: | June 9, 2015 Key Record Dates |
| Last Update Posted: | November 22, 2016 |
| Last Verified: | November 2016 |
Keywords provided by Bayer:
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Uterine fibroids Heavy Menstrual Bleeding |
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 Ulipristal acetate Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |