Clinical trial NCT02465814 (phase 2, status: completed)
Conditions: leiomyoma
ICD codes: D25.0, D25.1, D25.2, D25.9
Drugs: vilaprisan (bay1002670), vilaprisan (bay1002670, vilaprisan (bay1002670, vilaprisan (bay1002670), ulipristal, ulipristal, ulipristal
SMILES: C[C@]12C[C@H](C3=CC=C(C=C3)S(C)(=O)=O)C3=C4CCC(=O)C=C4CC[C@H]3[C@@H]1CC[C@@]2(O)C(F)(F)C(F)(F)F, C[C@]12C[C@H](C3=CC=C(C=C3)S(C)(=O)=O)C3=C4CCC(=O)C=C4CC[C@H]3[C@@H]1CC[C@@]2(O)C(F)(F)C(F)(F)F, C[C@]12C[C@H](C3=CC=C(C=C3)S(C)(=O)=O)C3=C4CCC(=O)C=C4CC[C@H]3[C@@H]1CC[C@@]2(O)C(F)(F)C(F)(F)F, C[C@]12C[C@H](C3=CC=C(C=C3)S(C)(=O)=O)C3=C4CCC(=O)C=C4CC[C@H]3[C@@H]1CC[C@@]2(O)C(F)(F)C(F)(F)F, CN(C)C1=CC=C(C=C1)[C@H]1C[C@@]2(C)[C@@H](CC[C@]2(O)C(C)=O)[C@@H]2CCC3=CC(=O)CCC3=C12, CN(C)C1=CC=C(C=C1)[C@H]1C[C@@]2(C)[C@@H](CC[C@]2(O)C(C)=O)[C@@H]2CCC3=CC(=O)CCC3=C12, CN(C)C1=CC=C(C=C1)[C@H]1C[C@@]2(C)[C@@H](CC[C@]2(O)C(C)=O)[C@@H]2CCC3=CC(=O)CCC3=C12
Eligibility 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.