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Ulipristal acetate

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Vilaprisan 2 mg oral daily over 8-12 weeks

Ulipristal 5 mg oral daily over 8-12 weeks

Patients undergoing surgery without any prior treatment, as control group

Daily single oral doses of 2 mg vilaprisan over 8-12 weeks

Vilaprisan, BAY1002670

Daily single oral doses of 5 mg ulipristal over 8-12 weeks

Ulipristal

Bayer Study Director

To investigate the clinical effects of vilaprisan and ulipristal acetate at molecular and cellular level on uterine and fibroid tissue taken from patients (after surgery / biopsy)

Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned

An Open-label, Parallel Group, Multi-center Study to Investigate Pharmacodynamic Effects After Daily Administration of Vilaprisan or Ulipristal Acetate for 8-12 Weeks in Patients With Uterine Fibroids for Whom Surgery (Hysterectomy or Myomectomy) is Planned

Pre-treatment biopsy: The endometrial biopsy will be performed between Day 6 to 13 of the menstrual cycle that occurs after the screening visit and before treatment commences. Post-treatment biopsy as second endometrial biopsy is taken (if possible within 24 hours) after end of VPR treatment.

Fibroid tissue sample will be collected from the uterus following surgery (if possible within 24 hours) after end of VPR treatment

Pre-treatment biopsy: The endometrial biopsy will be performed between Day 6 to 13 of the menstrual cycle that occurs after the screening visit and before treatment commences. Post-treatment biopsy as second endometrial biopsy is taken (if possible within 24 hours) after end of VPR treatment

Pre-treatment biopsy: The endometrial biopsy will be performed between Day 6 to 13 of the menstrual cycle that occurs after the screening visit and before treatment commences. Post-treatment biopsy as second endometrial biopsy is taken (if possible within 24 hours) after end of treatment. Fibroid tissue sample will be collected from the uterus following surgery (if possible within 24 hours) after end of treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned	NCT03342859	Leiomyoma	Vilaprisan, BAY... Ulipristal	18 Years -	Bayer
Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned	NCT03342859	Leiomyoma	Vilaprisan, BAY... Ulipristal	18 Years -	Bayer
Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned	NCT03342859	Leiomyoma	Vilaprisan, BAY... Ulipristal	18 Years -	Bayer

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