Phase 2
N=309
Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap
Leiomyoma
Bottom Line
View on ClinicalTrials.gov: NCT02131662 ↗Enrolled (actual)
309
Serious AEs
4.3%
Results posted
Dec 2017
Primary outcome: Primary: Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment — 60; 54.1; 55.7; 30 Percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BAY1002670 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Bayer
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment |
60; 54.1; 55.7; 30; 1.7 | — |
| SECONDARY Change in Volume of Menstrual Blood Loss Per 28 Days From Baseline During Treatment by Reference Period (Assessed by Alkaline Hematin Method) |
-79.83; -30.18; -55.42; -44.14; 17.22; -203.43 | — |
| SECONDARY Time to Onset of Controlled Bleeding |
2; 2; 3; 2; NA | — |
| SECONDARY Change in Volume of Largest Fibroid Compared to Baseline Measured by MRI |
-41.4; -27.2; -18.9; -14.9; 4.9; -26.9 | — |
Summary
The study is performed to assess the efficacy and safety of different doses of BAY1002670 in subjects with uterine fibroids. The dose-response relationship will be evaluated. Further, the study aims to establish a population pharmacokinetic/pharmacodynamic relationship for BAY1002670 in subjects with uterine fibroids. To assess the efficacy of BAY1002670 the interchangeability of menstrual pictogram and alkaline hematin method for the judgement of menstrual blood loss will be assessed.
Eligibility Criteria
Inclusion Criteria
- Signed and dated informed consent
- Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter 3.0 cm
- 18 to 50 years of age at the time of screening
- Heavy menstrual bleeding >80 mL documented by MP during the bleeding episode following the screening visit
- Normal or clinically insignificant cervical smear not requiring further follow-up
- An endometrial biopsy performed at the screening visit 1 (Visit 1), without significant histological disorder such as endometrial hyperplasia or other significant endometrial pathology
- Use of a non-hormonal barrier method of contraception starting at the bleeding episode following the screening visit 1 (Visit 1) until the end of the study
- Good general health (except for findings related to uterine fibroids)
Exclusion Criteria
- Pregnancy or lactation
- Uterine fibroid with largest diameter >10.0 cm
- Hypersensitivity to any ingredient of the study drug
- Laboratory values outside inclusion range before randomization and considered as clinically relevant
- Hemoglobin values <6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values <10.9 g/dL will receive 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
Data sourced from ClinicalTrials.gov (NCT02131662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.