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Ulipristal Use in Chinese Population

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ClinicalTrials.gov Identifier: NCT02825719
Recruitment Status : Terminated (Ulipristal was withdrawal from the market)
First Posted : July 7, 2016
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Lui Man Wa, Queen Mary Hospital, Hong Kong

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fibroid Drug: Ulipristal acetate Other: Placebo pills Drug: Ferrous sulphate Drug: Tranexamic Acid Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study on the Pre-operative Use of Ulipristal on Fibroid in Chinese Population
Actual Study Start Date : December 2, 2015
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ulipristal
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.
Drug: Ulipristal acetate
Ulipristal acetate 5mg daily will be prescribed
Other Name: Esyma

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

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

Placebo Comparator: Placebo
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.
Other: Placebo pills
Placebo pills will be prescribed

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

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




Primary Outcome Measures :
  1. Change of uterine bleeding [ Time Frame: Through study completion, an average of 14weeks ]
    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.


Secondary Outcome Measures :
  1. Change of haemoglobin level [ Time Frame: Through study completion, an average of 14weeks ]
    The change of haemoglobin level after completion of 12 weeks course will be recorded.

  2. Change of fibroid volume [ Time Frame: Through study completion, an average of 14weeks ]
    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.

  3. Intraoperative blood loss [ Time Frame: After completion of 12 weeks course, the intraoperative blood loss at the time of performance of hysterectomy will be assessed. ]
    The amount of blood loss at hysterectomy will be recorded.

  4. Conversion to less invasive intervention options [ Time Frame: After completion of 12 weeks course of treatment and before the scheduled operation ]
    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.

  5. Side effects [ Time Frame: Through study completion, an average of 14weeks ]
    The side effects including nausea, vomiting, headache, dyspepsia will be recorded.

  6. Histology of the operative specimen [ Time Frame: After completion of 12 weeks course of treatment ]
    Presence of malignancy or hyperplasia in the operative specimen will be recorded.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for hysterectomy for symptomatic fibroid
  • Be a Chinese
  • Pre-menopausal
  • With a Pictorial bleeding assessment chart score > 100 during menstruation at the preceding month
  • Non-pregnant
  • With a body-mass index between 18 to 30.

Exclusion Criteria:

  • History of uterine surgery (apart from Caesarean section or cervical conization), endometrial ablation or uterine artery embolization
  • History of gynaecological malignancies
  • History of endometrial hyperplasia
  • Known haemoglobinopathy (e.g. thalassaemia)
  • Known severe coagulation disorder
  • Has one or more ovarian cysts >= 4 cm in diameter diagnosed by ultrasound
  • History of use of Selective Progesterone Receptor Modulator (SPRM)
  • Current (within 12 months) problem with alcohol or drug abuse.
  • Known allergy to SPRM or ferrous sulphate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825719


Locations
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Hong Kong
Department of Obstetrics and Gynaecology, Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Queen Mary Hospital, Hong Kong
Investigators
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Study Director: Ernest H. Y. Ng The University of Hong Kong, HONG KONG
Publications of Results:
Other Publications:
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Responsible Party: Lui Man Wa, Dr, Queen Mary Hospital, Hong Kong
ClinicalTrials.gov Identifier: NCT02825719    
Other Study ID Numbers: UW 15-022
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is to protect the privacy of individual patients
Keywords provided by Lui Man Wa, Queen Mary Hospital, Hong Kong:
Fibroid
Ulipristal
Selective progesterone receptor modulator
Chinese
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Tranexamic Acid
Ulipristal acetate
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs