Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

All Drugs and Chemicals

Antineoplastic Agents

Reproductive Control Agents

Hormones

Leuprolide

Ulipristal acetate

Contraceptive Agents

Contraceptive Agents, Hormonal

Contraceptive Agents, Female

11.25 mg Leuproreline injections at the onset of pretreatment with placebo tablets (once daily)

Three months of Ulipristal 5 mg once daily combined with a single saline injection at the onset of pretreatment (produced as placebo of Leuproreline)

No pre-treatment prior to laparoscopic myomectomy

GnRHa

Ulipristal

Inge de Milliano, MD

Marchien van Baal

P Van Kesteren

Andreas Thurkow

Wouter Hehenkamp, PhD

D Schoot

Jonas van de Lande

Sjors Coppus

M Aktas

M Bongers

Rationale: Laparoscopic myomectomy is increasingly performed over laparotomic myomectomy, because of the many benefits for the patient in terms of pain, hospital stay and recovery. In order to increase the success rate of a laparoscopic procedure pre-treatment to decrease the volume might be beneficial. Gonadotropin-releasing hormone agonists (GnRHa) are used for this purpose with good results in terms of volume reduction, but sometimes resulting in loss of distinction of the right surgical planes. Ulipristal is a new pre-operative treatment option for symptomatic fibroids, which has demonstrated good results in terms of volume reduction. The effect on cleavage planes is unknown. This study is performed to evaluate if Ulipristal is as effective as GnRHa in terms of surgical outcome.

Objective: to investigate if Ulipristal is non-inferior to GnRH in terms of intra-operative blood-loss (primary outcome), surgical time, surgical ease, complications, quality of life and costs.

Study design: Double blind randomized controlled multi-center trial. Study population: Premenopausal women in whom a maximum of 2 symptomatic intramural fibroids between 5 and 12 cm in diameter will be removed. Fibroid types 3, 4, 5, 6 and 2-5 will be included.

Intervention: Three months of Ulipristal 5 mg once daily combined with a single saline injection at the onset of pretreatment (produced as placebo of Leuproreline) or (comparison) 11.25 mg Leuproreline injections at the onset of pretreatment with placebo tablets (once daily) .

Methods: Within 1 month after pre-treatment patients will undergo a laparoscopic myomectomy by experienced surgeons. Operative characteristics will be recorded prospectively. Follow up will be 6 months after surgery mainly for quality of life assessment. A cost utility analysis will be conducted alongside the trial.

Main study parameters/endpoints: Ulipristal is non-inferior to GnRHa in terms of blood loss during surgery when the average difference between the two groups is below 150 ml (standard deviation 250 ml).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both Ulipristal and GnRHa have been registered for this indication. Safety has been tested and no specific risks apply.

Ulipristal vs. GnRHa Prior to Laparoscopic Myomectomy

Ulipristal Versus Gonadotropin-releasing Hormone Agonists Prior to Laparoscopic Myomectomy: a Double Blind Randomized Controlled Trial

Ulipristal is non-inferior to GnRHa in terms of blood loss during surgery when the average difference between the two groups is below 150 ml (standard deviation 250 ml)

Amsterdam UMC, location VUmc

Symptoms and General Pathology

Hemorrhage

Neoplasms, Connective Tissue

Connective Tissue Diseases

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

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

Bayer

Coagulants

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Mineral

Tranexamic Acid

Chrysarobin

Progesterone

Antifibrinolytic Agents

Hemostatics

Iron Supplement

Patients will be prescribed Ulipristal acetate 5mg daily for 12 weeks before operation. If the patients have anaemia with haemoglobin less than 10g/dL, ferrous sulphate 300mg three times a day will be prescribed as well. Tranexamic Acid 500mg four times a day will be prescribed on request basis.

Patients will be prescribed placebo pills daily for 12 weeks before operation. If the patients have anaemia with haemoglobin less than 10g/dL, ferrous sulphate 300mg three times a day will be prescribed as well. Tranexamic Acid 500mg four times a day will be prescribed on request basis.

Ulipristal acetate 5mg daily will be prescribed

Placebo pills

Ferrous sulphate 300mg three times a day will be prescribed if haemoglobin level is less than 10g/dL.

Ferrous sulphate

Tranexamic Acid 500mg four times a day on request basis will be prescribed if patient complained of menorrhagia.

Ernest H. Y. Ng

Uterine leiomyomas is the commonest benign tumour of the female genital tract. It lead to menorrhagia, anaemia, pain and pressure symptoms. Due to the enlarged uterus, the use of minimal invasive surgery is limited. There is also increase risk of intraoperative blood transfusion. Ulipristal acetate (UPA) is a selective progesterone-receptor modulator (SPRM). Preoperative use of Ulipristal for 12 weeks has been shown to decrease uterine bleeding, fibroid volume, pre-operative anaemia and symptoms severity. However there is still lacking evidence in terms of long term safety and efficacy, especially in Chinese population. The aim of the present study is to evaluate the effect and safety on preoperative use of Ulipristal on fibroid.

Uterine leiomyomas is the commonest benign tumour of the female genital tract. It is often asymptomatic, but can also lead to anaemia, pain and pressure symptoms. It is the commonest indication for hysterectomy, especially abdominal hysterectomy. Currently, the use of hormonal treatment is associated with side effects including gastrointestinal upset, bloating, weight gain and thromboembolic risks. The main stay for treatment relies on surgery.

Furthermore, the use of minimal invasive surgeries is limited by the size of the fibroids. Preoperative use of Gonadotrophic Releasing Hormone analogues (GnRHa) is effective in shrinkage of the uterine leiomyomas and reduction of uterine bleeding. However, postmenopausal symptoms including hot flushes, vaginal dryness are profound.

Ulipristal acetate (UPA), previously named CDB-2914, is a selective progesterone-receptor modulator (SPRM). It binds to the progesterone receptors with high affinity. It inhibits follicular development and ovulation, while it has no significant effects on estradiol levels and antiglucocorticoid activity. Preoperative use of Ulipristal for symptomatic uterine fibroids has been investigated in randomized controlled study with improvement in terms of uterine bleeding, fibroids volume, pre-operative anaemia and symptoms severity. However there is still lacking evidence in terms of long term safety and efficacy. Also there is lack of evidence in Chinese population.

The aim of the present study is to evaluate the effect and safety on preoperative use of Ulipristal on fibroid.

Ulipristal Use in Chinese Population

Pilot Study on the Pre-operative Use of Ulipristal on Fibroid in Chinese Population

This is to protect the privacy of individual patients

Pictorial bleeding assessment chart will be used for assessment of uterine bleeding. Patients will be assessed before the start of treatment, after completion of 6 weeks course and after completion of 12 weeks course. The change of uterine bleeding after completion of 12 weeks course of treatment will be recorded.

The change of haemoglobin level after completion of 12 weeks course will be recorded.

The fibroid volume will be measured using ultrasonography before start of treatment, after 6 weeks course of treatment and after completion of 12 weeks course of treatment.

The amount of blood loss at hysterectomy will be recorded.

2 weeks before scheduled operation, patients will be assessed by the operation team and the most suitable route of hysterectomy will be discussed again. The possibility of conversion to less invasive intervention options including from laparotomy to laparoscopy will be recorded.

The side effects including nausea, vomiting, headache, dyspepsia will be recorded.

Presence of malignancy or hyperplasia in the operative specimen will be recorded.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ulipristal vs. GnRHa Prior to Laparoscopic Myomectomy	NCT02288130	Fibroids	GnRHa Ulipristal	18 Years -	Amsterdam UMC, location VUmc
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
Ulipristal vs. GnRHa Prior to Laparoscopic Myomectomy	NCT02288130	Fibroids	GnRHa Ulipristal	18 Years -	Amsterdam UMC, location VUmc
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
Ulipristal Use in Chinese Population	NCT02825719	Fibroid	Ulipristal acet... Placebo pills Ferrous sulphat... Tranexamic Acid	18 Years -	Queen Mary Hospital, Hong Kong
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

Spots Global Cancer Trial Database for ulipristal

Every month we try and update this database with for ulipristal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ulipristal

Every month we try and update this database with for ulipristal cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ulipristal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.