FibroidPhase 4NCT02825719
Ulipristal Use in Chinese Population
A Phase 4 study testing Ulipristal acetate, Ferrous sulphate and Tranexamic Acid in people with Fibroid, run by Queen Mary Hospital, Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibroid
- What is being tested?
- Ulipristal acetate, Ferrous sulphate and Tranexamic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Dec 2015to 31 Mar 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Obstetrics and Gynaecology, Queen Mary Hospital
Hong Kong
About this study
Official title: Pilot Study on the Pre-operative Use of Ulipristal on Fibroid in Chinese Population
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.
Read the 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.
- Conditions
- Fibroid
- Being tested
- Ulipristal acetate, Placebo pills, Ferrous sulphate, Tranexamic Acid
- Keywords
- Fibroid, Ulipristal, Selective progesterone receptor modulator, Chinese
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulipristal acetateDrug
Also called Esyma
Ulipristal acetate 5mg daily will be prescribed
Placebo pillsOther
Placebo pills will be prescribed
Ferrous sulphateDrug
Also called Ferasul
Ferrous sulphate 300mg three times a day will be prescribed if haemoglobin level is less than 10g/dL.
Tranexamic AcidDrug
Also called Transamin
Tranexamic Acid 500mg four times a day on request basis will be prescribed if patient complained of menorrhagia.
| Study group | Role | What they receive |
|---|---|---|
| Ulipristal | Experimental | 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. Receives: Drug: Ulipristal acetate; Drug: Ferrous sulphate; Drug: Tranexamic Acid |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo pills; Drug: Ferrous sulphate; Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of uterine bleeding
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.
Measured: Through study completion, an average of 14weeks
Secondary outcomes (6)
Change of haemoglobin level
The change of haemoglobin level after completion of 12 weeks course will be recorded.
Measured: Through study completion, an average of 14weeks
Change of fibroid volume
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.
Measured: Through study completion, an average of 14weeks
Intraoperative blood loss
The amount of blood loss at hysterectomy will be recorded.
Measured: After completion of 12 weeks course, the intraoperative blood loss at the time of performance of hysterectomy will be assessed.
Conversion to less invasive intervention options
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.
Measured: After completion of 12 weeks course of treatment and before the scheduled operation
Side effects
The side effects including nausea, vomiting, headache, dyspepsia will be recorded.
Measured: Through study completion, an average of 14weeks
Histology of the operative specimen
Presence of malignancy or hyperplasia in the operative specimen will be recorded.
Measured: After completion of 12 weeks course of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start2 Dec 2015
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Why it stopped: Ulipristal was withdrawal from the market
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for FibroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lui Man Wa, Queen Mary Hospital, Hong Kong
- Investigators
- Ernest H. Y. Ng, Study director, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825719
- Sponsor's protocol ID
- UW 15-022
- Status last verified
- Apr 2020
- First submitted
- 29 May 2016
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: This is to protect the privacy of individual patients
Publications
Parker WH. Etiology, symptomatology, and diagnosis of uterine myomas. Fertil Steril. 2007 Apr;87(4):725-36. doi: 10.1016/j.fertnstert.2007.01.093.
PubMed 17430732Jacobson GF, Shaber RE, Armstrong MA, Hung YY. Hysterectomy rates for benign indications. Obstet Gynecol. 2006 Jun;107(6):1278-83. doi: 10.1097/01.AOG.0000210640.86628.ff.
PubMed 16738152Jacoby VL, Autry A, Jacobson G, Domush R, Nakagawa S, Jacoby A. Nationwide use of laparoscopic hysterectomy compared with abdominal and vaginal approaches. Obstet Gynecol. 2009 Nov;114(5):1041-1048. doi: 10.1097/AOG.0b013e3181b9d222.
PubMed 20168105Lethaby A, Vollenhoven B, Sowter M. Pre-operative GnRH analogue therapy before hysterectomy or myomectomy for uterine fibroids. Cochrane Database Syst Rev. 2001;(2):CD000547. doi: 10.1002/14651858.CD000547.
PubMed 11405968Blithe DL, Nieman LK, Blye RP, Stratton P, Passaro M. Development of the selective progesterone receptor modulator CDB-2914 for clinical indications. Steroids. 2003 Nov;68(10-13):1013-7. doi: 10.1016/s0039-128x(03)00118-1.
PubMed 14667994Nieman LK, Blocker W, Nansel T, Mahoney S, Reynolds J, Blithe D, Wesley R, Armstrong A. Efficacy and tolerability of CDB-2914 treatment for symptomatic uterine fibroids: a randomized, double-blind, placebo-controlled, phase IIb study. Fertil Steril. 2011 Feb;95(2):767-72.e1-2. doi: 10.1016/j.fertnstert.2010.09.059. Epub 2010 Nov 5.
PubMed 21055739Donnez J, Tatarchuk TF, Bouchard P, Puscasiu L, Zakharenko NF, Ivanova T, Ugocsai G, Mara M, Jilla MP, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL I Study Group. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med. 2012 Feb 2;366(5):409-20. doi: 10.1056/NEJMoa1103182.
PubMed 22296075
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Pre-operative Use of Ulipristal on Fibroid in Chinese Population
- ClinicalTrials.gov ID
- NCT02825719
- Acronym / sponsor ID
- UW 15-022
- Conditions
- Fibroid
- Keywords
- Fibroid, Ulipristal, Selective progesterone receptor modulator, Chinese
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Ulipristal was withdrawal from the market
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Queen Mary Hospital, Hong KongUniversity, hospital or other
- Study start
- 2 Dec 2015 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulipristal | Experimental | Drug: Ulipristal acetate, Drug: Ferrous sulphate, Drug: Tranexamic AcidPatients 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. |
| Placebo | Placebo comparator | Other: Placebo pills, Drug: Ferrous sulphate, Drug: Tranexamic AcidPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ulipristal acetateAlso: EsymaUlipristal acetate 5mg daily will be prescribed | Drug | Ulipristal |
| Placebo pillsPlacebo pills will be prescribed | Other | Placebo |
| Ferrous sulphateAlso: FerasulFerrous sulphate 300mg three times a day will be prescribed if haemoglobin level is less than 10g/dL. | Drug | Placebo, Ulipristal |
| Tranexamic AcidAlso: TransaminTranexamic Acid 500mg four times a day on request basis will be prescribed if patient complained of menorrhagia. | Drug | Placebo, Ulipristal |
Primary outcome
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.
6 secondary outcomes
Change of haemoglobin level
Time frame: Through study completion, an average of 14weeks
Change of fibroid volume
Time frame: Through study completion, an average of 14weeks
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.
Conversion to less invasive intervention options
Time frame: After completion of 12 weeks course of treatment and before the scheduled operation
Side effects
Time frame: Through study completion, an average of 14weeks
Histology of the operative specimen
Time frame: After completion of 12 weeks course of treatment
Results and safety
The study was stopped early (reason given: Ulipristal was withdrawal from the market). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Background: PubMed 17430732Parker WH. Etiology, symptomatology, and diagnosis of uterine myomas. Fertil Steril. 2007 Apr;87(4):725-36. doi: 10.1016/j.fertnstert.2007.01.093.
- Background: PubMed 16738152Jacobson GF, Shaber RE, Armstrong MA, Hung YY. Hysterectomy rates for benign indications. Obstet Gynecol. 2006 Jun;107(6):1278-83. doi: 10.1097/01.AOG.0000210640.86628.ff.
- Background: PubMed 20168105Jacoby VL, Autry A, Jacobson G, Domush R, Nakagawa S, Jacoby A. Nationwide use of laparoscopic hysterectomy compared with abdominal and vaginal approaches. Obstet Gynecol. 2009 Nov;114(5):1041-1048. doi: 10.1097/AOG.0b013e3181b9d222.
- Background: PubMed 11405968Lethaby A, Vollenhoven B, Sowter M. Pre-operative GnRH analogue therapy before hysterectomy or myomectomy for uterine fibroids. Cochrane Database Syst Rev. 2001;(2):CD000547. doi: 10.1002/14651858.CD000547.
- Background: PubMed 14667994Blithe DL, Nieman LK, Blye RP, Stratton P, Passaro M. Development of the selective progesterone receptor modulator CDB-2914 for clinical indications. Steroids. 2003 Nov;68(10-13):1013-7. doi: 10.1016/s0039-128x(03)00118-1.
- Background: PubMed 21055739Nieman LK, Blocker W, Nansel T, Mahoney S, Reynolds J, Blithe D, Wesley R, Armstrong A. Efficacy and tolerability of CDB-2914 treatment for symptomatic uterine fibroids: a randomized, double-blind, placebo-controlled, phase IIb study. Fertil Steril. 2011 Feb;95(2):767-72.e1-2. doi: 10.1016/j.fertnstert.2010.09.059. Epub 2010 Nov 5.
- Results publication: PubMed 22296075Donnez J, Tatarchuk TF, Bouchard P, Puscasiu L, Zakharenko NF, Ivanova T, Ugocsai G, Mara M, Jilla MP, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL I Study Group. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med. 2012 Feb 2;366(5):409-20. doi: 10.1056/NEJMoa1103182.
- Individual participant dataSharing planned: No. This is to protect the privacy of individual patients
Related trials for Fibroid
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
RecruitingObservational study
The Effects of Uterine Fibroids on Pregnancy in Women
Female Infertility, Uterine Fibroid
RecruitingObservational study
Epidemiology and Risk Factors of Uterine Fibroids in China
Uterine Fibroid
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernest H. Y. Ng study director
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ulipristal acetate, Ferrous sulphate and Tranexamic Acid in people with Fibroid, run by Queen Mary Hospital, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Ulipristal was withdrawal from the market). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of uterine bleeding (time frame: Through study completion, an average of 14weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02825719, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.