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

Leiomyoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03342859
• Other study ID #: 15791
• Secondary ID: 2017-000468-13
• Status: Terminated
• Phase: Phase 1
• Start date: November 16, 2017
• Est. completion date: January 13, 2020

Study information

• Verified date: January 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 13, 2020
• Est. primary completion date: December 17, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients 18 years and older and premenopausal (based on gynecological history i.e. still menstruating; no significant estrogen deficiency symptoms)

• Diagnosis of uterine fibroids documented by ultrasound and relevant symptoms reported by the patient (e.g. heavy menstrual bleeding, pelvic pressure)

• Patients for whom surgery (hysterectomy or myomectomy) for the treatment of symptomatic uterine fibroids is planned

• Patients who are otherwise healthy as shown by medical history, physical and gynecological examinations, and laboratory test results

Exclusion Criteria:

• Contraindications for the progesterone receptor modulators (PRM) vilaprisan or ulipristal acetate

• Use of medication that might interfere with the conduct of the study or the interpretation of the results (e.g. continuing use of hormonal contraceptives, tranexamic acid or other treatments for heavy menstrual bleeding, progesterone receptor modulators, gonadotropin-releasing hormone agonist, anticoagulants, moderate and strong CYP3A4 inducers and moderate and strong CYP3A4 inhibitors within a defined time period before treatment starts.

Related Conditions & MeSH terms

• Leiomyoma

Intervention

Drug:
• Vilaprisan, BAY1002670
Daily single oral doses of 2 mg vilaprisan over 8-12 weeks
• Ulipristal
Daily single oral doses of 5 mg ulipristal over 8-12 weeks

Locations

Country	Name	City	State
United Kingdom	Edinburgh Royal Infirmary/ NHS Lothian	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The expression level of biomarker for glandular and stromal cell proliferation (Ki-67) in the endometrium of the same patient before treatment and when treated with VPR (vilaprisan) prior to surgery	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.	From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks
Primary	The expression level of biomarker for myoma cell proliferation (Ki-67) in fibroid tissue of patients not treated with PRM (progesterone receptor modulator )and those who have been treated with VPR prior to surgery	Fibroid tissue sample will be collected from the uterus following surgery (if possible within 24 hours) after end of VPR treatment	After maximum 12 weeks of treatment
Primary	The expression level of biomarkers for apoptotic regulation in the endometrium (BCL-2 (B-cell lymphoma 2), caspase 3) of the same patient before treatment and when treated with VPR prior to surgery	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	From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks
Primary	The expression level of biomarkers for apoptotic regulation in fibroid tissue (BCL-2, caspase 3) of patients not treated with PRM and those who have been treated with VPR prior to surgery	Fibroid tissue sample will be collected from the uterus following surgery (if possible within 24 hours) after end of VPR treatment	After maximum 12 weeks of treatment
Primary	The expression level of nuclear hormone receptors in the endometrium (progesterone receptor (PR), PR-B, estrogen receptor (ER), androgen receptor (AR)) of the same patient before treatment and when treated with VPR prior to surgery	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	From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks
Secondary	The expression levels of biomarkers (Ki-67, caspase 3 and BCL-2) in the endometrium of the same patient before treatment and when treated with UPA prior to surgery	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	From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks
Secondary	The expression levels of biomarkers (Ki-67, caspase 3 and BCL-2) in fibriod tissue of patients not treated with PRM and those who have been treated with UPA prior to surgery	Fibroid tissue sample will be collected from the uterus following surgery (if possible within 24 hours) after end of VPR treatment	After maximum 12 weeks of treatment

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