AdenomyosisPhase 2/3ETESRTANCT03520439
Evaluation of Therapeutic Effect and Safety of Mifepristone in the Treatment of Adenomyosis
A Phase 2/3 study testing Mifepristone in people with Adenomyosis, run by xinmei zhang at 1 site in China.
Trial summary
This clinical trial is designed to study the effectiveness and safety of mifepristone in the treatment of symptomatic adenomyosis with multi center, random, double blind and controlled clinical trials. This multicenter study is performed in 150 subjects who are diagnosed as adenomyosis . Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Adenomyosis
- What is being tested?
- Mifepristone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- 19 May 2018to 1 Oct 2019
- Phase
- Phase 2/3
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- B-ultrasound or magnetic resonance imaging (MRI) examination confirmed that the subject has adenomyosis, and the uterus is less than 10 weeks of pregnancy;
- Visual analogue scale (VAS) of adenomyosis-associated pain> 0 points; with or without menorrhagia (PBAC≥100 points);
- Women between 18 and 50 years old who currently have no childbearing requirements;
- Normal or cervical cytology results without clinical significance (results within 6 months before the screening period);
- Willing to choose a barrier method of contraception if contraception is needed;
- Be tested voluntarily and sign the informed consent.
- No menopause
- No menopause
Who cannot join
- HB<90G/L
- Undiagnosed abnormal vaginal bleeding or endometrial lesions;
- Pregnancy and lactation women and those who are preparing to give birth when taking the medication or within 6 months of stopping the medication;
- Malignant tumors (including the reproductive system and other systems);
- The patients with severe heart, liver, kidney disease and adrenocortical insufficiency;
- The results of follow-up laboratory test indicate abnormal clinical significance;
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- The allergic persons or those who have been allergic to multiple drugs, or are allergic to active ingredients or any excipients of the study drug;
- Suffering from any disease or condition that may cause the study drug to alter absorption, accumulate excessively, affect metabolism, or change the excretion pattern;
- Having clinically significant depression within the current or most recent year;
- People who regularly take analgesics due to other underlying diseases;
- Ketoconazole, itraconazole, erythromycin, rifampicin, corticosteroids (hydrocortisone, prednisone, dexamethasone, etc.), and some anticonvulsants (phenytoin, phenobarbital, carbamazepine, etc.), griseofulvin, non-steroidal anti-inflammatory drugs (aspirin, acetaminophen, etc.) that are being used and cannot be stopped during the study;
- Previous use of hormone drugs, including: a. use of GnRH agonists within 6 months before the screening period; b. use of progestins or danazol and other long-acting hormones within 3 months before the screening period; c. use of oral contraceptive-like short-acting hormones within one month before the screening period;
- Patients who participated in other clinical trials within 3 months before the screening, or who are considered inappropriate to participate in the study by other investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mifepristone Versus Placebo to Treat Adenomyosis: a Double-blind, Multicentre，Randomized Clinical Trial
This clinical trial is designed to study the effectiveness and safety of mifepristone in the treatment of symptomatic adenomyosis with multi center, random, double blind and controlled clinical trials. This multicenter study is performed in 150 subjects who are diagnosed as adenomyosis . Twelve weeks of randomization, allocation concealment, double-blind, placebo-controlled, parallel grouping. Subjects are randomly assigned to one of two treatment groups and received one of the following treatments:
- Mifepristone tablets of 10mg, 1 tablet daily, oral
- Placebo, 1 tablet daily, oral
Read the detailed description
Adenomyosis is a common benign disease of Gynecology, with secondary progressive dysmenorrhea and menorrhagia as the main clinical manifestations, which seriously harm the physical and mental health of the patients. Most patients have the desire to retain the uterus. Therefore, the treatment of drug conservative treatment is dominant in the treatment of adenomyosis. However, the current clinical treatment of adenomyosis still has some limitations and needs to be improved. Therefore, it is imperative to expand the clinical medication of adenomyosis.
Mifepristone is defined as a selective progesterone receptor modulator. Under specific conditions, it plays the role of anti progestin, inhibits endometrial proliferation, inhibits ovulation, and can cause reversible amenorrhea. In recent years, it has been widely used in of uterine leiomyoma and endometriosis. Adenomyosis is also closely related to hormone related diseases, especially endometriosis. At present, the study of mifepristone in the treatment of adenomyosis is more extensive in China. A large number of domestic literature reports that low dose mifepristone for the treatment of adenomyosis is safe and effective for the treatment of adenomyosis . During the treatment of mifepristone, most of the patients had amenorrhea, obviously alleviating dysmenorrhea and reducing the menstrual volume, reducing the uterine and lesion volume of the patients with adenomyosis . However, most of the domestic literature is a small sample case control study or retrospective study. There is no randomized double blind control study. There is no clinical study on the application of mifepristone to adenomyosis in foreign countries. Therefore, the clinical evidence is inadequate, and a high quality randomized controlled trial is still needed. The purpose of this study is to demonstrate the effectiveness and safety of mifepristone (10mg) in the treatment of symptomatic adenomyosis with multi center, random, double blind and controlled clinical trials. It is a new clinical study for the old medicine.
- Conditions
- Adenomyosis
- Being tested
- Mifepristone, Placebo
- Keywords
- Adenomyosis, mifepristone, the selective progesterone receptor modulators, treatment
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Also called RU486
Oral mifepristone 10mg (first menstrual third days), 1 times a day, 12 weeks, fasting or taking 2 hours after eating
PlaceboDrug
Oral Placebo Oral Tablet 1# (first menstrual third days), 1 times a day, 12 weeks, fasting or taking 2 hours after eating
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | mifepristone tablets ，10mg，One tablet daily, oral treatment Receives: Drug: Mifepristone |
| control group | Placebo comparator | placebo，10mg，One tablet daily, oral treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in chronic pelvic pain associated with adenomyosis
To evaluate the visual analogue scale (VAS) changes.By using 10-cm visual analogue scales (0 = no pain, 10 = worst pain). Women will be asked to give the pain score at each follow up (i.e.Baseline ,taking medicine for 1-month, 2-month, 3-month, post treatment 1- month )
Measured: Baseline ,taking medicine for 1-month, 2-month, 3-month and post treatment 1- month（approximately 16 weeks）
Secondary outcomes (3)
changes in uterine bleeding
To evaluate the pictorial blood loss assessment chart (PBAC) changes
Measured: Baseline ,taking medicine for 1-month, 2-month, 3-month and post treatment 1- month（approximately 16 weeks）
improvement of anemia
To evaluate the hemoglobin changes,
Measured: Baseline ,taking medicine for 1-month, 3-month （approximately 16 weeks）
Size of uterus
To evaluate the uterine volume changes
Measured: Baseline ,taking medicine for 1-month, 3-month （approximately 16 weeks）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start19 May 2018
- Primary completion31 Jul 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdenomyosisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- xinmei zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Anhui Province Cancer Hospital, Huzhou Maternity and Child Care Hospital, Jiaxing Maternity and Child Health Care Hospital, Jinhua Municipal Central Hospital, The Central Hospital of Lishui City, The Affiliated Hospital of Medical School of Ningbo University, Ningbo Maternity and Child Care Hospital, The People's Hospital of Quzhou, Shaoxing Women and Children's Hospital, First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Sir Run Run Shaw Hospital, Taizhou First People's Hospital, Zhoushan Maternity and Infant Hospital, Shaoxing People's Hospital
- Responsible party
- Sponsor-investigator, xinmei zhang, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520439
- Sponsor's protocol ID
- MF2018
- Acronym
- ETESRTA
- Status last verified
- Oct 2019
- First submitted
- 27 Apr 2018
- Last updated
- 3 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Che X, Wang J, Sun W, He J, Wang Q, Zhu D, Zhu W, Zhang J, Dong J, Xu J, Zheng F, Zhou J, Zhao W, Lin Q, Ye L, Zhao X, Xu Z, Chen Y, Wang J, Wu W, Zhai L, Zhou Y, Zheng J, Zhang X. Effect of Mifepristone vs Placebo for Treatment of Adenomyosis With Pain Symptoms: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2317860. doi: 10.1001/jamanetworkopen.2023.17860.
PubMed 37307001
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mifepristone Versus Placebo to Treat Adenomyosis: a Double-blind, Multicentre，Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03520439
- Acronym / sponsor ID
- ETESRTA / MF2018
- Conditions
- Adenomyosis
- Keywords
- Adenomyosis, mifepristone, the selective progesterone receptor modulators, treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- xinmei zhangUniversity, hospital or other
- Collaborators
- Anhui Province Cancer Hospital, Huzhou Maternity and Child Care Hospital, Jiaxing Maternity and Child Health Care Hospital, Jinhua Municipal Central Hospital, The Central Hospital of Lishui City, The Affiliated Hospital of Medical School of Ningbo University, Ningbo Maternity and Child Care Hospital, The People's Hospital of Quzhou, Shaoxing Women and Children's Hospital, First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Sir Run Run Shaw Hospital, Taizhou First People's Hospital, Zhoushan Maternity and Infant Hospital, Shaoxing People's Hospital
- Study start
- 19 May 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 9 May 2018 (actual)
- 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.
This clinical trial is designed to study the effectiveness and safety of mifepristone in the treatment of symptomatic adenomyosis with multi center, random, double blind and controlled clinical trials. This multicenter study is performed in 150 subjects who are diagnosed as adenomyosis . Twelve weeks of randomization, allocation concealment, double-blind, placebo-controlled, parallel grouping. Subjects are randomly assigned to one of two treatment groups and received one of the following treatments:
- Mifepristone tablets of 10mg, 1 tablet daily, oral
- Placebo, 1 tablet daily, oral
Detailed description
Adenomyosis is a common benign disease of Gynecology, with secondary progressive dysmenorrhea and menorrhagia as the main clinical manifestations, which seriously harm the physical and mental health of the patients. Most patients have the desire to retain the uterus. Therefore, the treatment of drug conservative treatment is dominant in the treatment of adenomyosis. However, the current clinical treatment of adenomyosis still has some limitations and needs to be improved. Therefore, it is imperative to expand the clinical medication of adenomyosis.
Mifepristone is defined as a selective progesterone receptor modulator. Under specific conditions, it plays the role of anti progestin, inhibits endometrial proliferation, inhibits ovulation, and can cause reversible amenorrhea. In recent years, it has been widely used in of uterine leiomyoma and endometriosis. Adenomyosis is also closely related to hormone related diseases, especially endometriosis. At present, the study of mifepristone in the treatment of adenomyosis is more extensive in China. A large number of domestic literature reports that low dose mifepristone for the treatment of adenomyosis is safe and effective for the treatment of adenomyosis . During the treatment of mifepristone, most of the patients had amenorrhea, obviously alleviating dysmenorrhea and reducing the menstrual volume, reducing the uterine and lesion volume of the patients with adenomyosis . However, most of the domestic literature is a small sample case control study or retrospective study. There is no randomized double blind control study. There is no clinical study on the application of mifepristone to adenomyosis in foreign countries. Therefore, the clinical evidence is inadequate, and a high quality randomized controlled trial is still needed. The purpose of this study is to demonstrate the effectiveness and safety of mifepristone (10mg) in the treatment of symptomatic adenomyosis with multi center, random, double blind and controlled clinical trials. It is a new clinical study for the old medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: Mifepristonemifepristone tablets ，10mg，One tablet daily, oral treatment |
| control group | Placebo comparator | Drug: Placeboplacebo，10mg，One tablet daily, oral treatment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- B-ultrasound or magnetic resonance imaging (MRI) examination confirmed that the subject has adenomyosis, and the uterus is less than 10 weeks of pregnancy;
- Visual analogue scale (VAS) of adenomyosis-associated pain> 0 points; with or without menorrhagia (PBAC≥100 points);
- Women between 18 and 50 years old who currently have no childbearing requirements;
- Normal or cervical cytology results without clinical significance (results within 6 months before the screening period);
- Willing to choose a barrier method of contraception if contraception is needed;
Key exclusion criteria (13 listed)
- HB<90G/L
- Undiagnosed abnormal vaginal bleeding or endometrial lesions;
- Pregnancy and lactation women and those who are preparing to give birth when taking the medication or within 6 months of stopping the medication;
- Malignant tumors (including the reproductive system and other systems);
- The patients with severe heart, liver, kidney disease and adrenocortical insufficiency;
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 |
|---|---|---|
| MifepristoneAlso: RU486Oral mifepristone 10mg (first menstrual third days), 1 times a day, 12 weeks, fasting or taking 2 hours after eating | Drug | study group |
| PlaceboOral Placebo Oral Tablet 1# (first menstrual third days), 1 times a day, 12 weeks, fasting or taking 2 hours after eating | Drug | control group |
Primary outcome
changes in chronic pelvic pain associated with adenomyosis
Time frame: Baseline ,taking medicine for 1-month, 2-month, 3-month and post treatment 1- month（approximately 16 weeks）
To evaluate the visual analogue scale (VAS) changes.By using 10-cm visual analogue scales (0 = no pain, 10 = worst pain). Women will be asked to give the pain score at each follow up (i.e.Baseline ,taking medicine for 1-month, 2-month, 3-month, post treatment 1- month )
3 secondary outcomes
changes in uterine bleeding
Time frame: Baseline ,taking medicine for 1-month, 2-month, 3-month and post treatment 1- month（approximately 16 weeks）
improvement of anemia
Time frame: Baseline ,taking medicine for 1-month, 3-month （approximately 16 weeks）
Size of uterus
Time frame: Baseline ,taking medicine for 1-month, 3-month （approximately 16 weeks）
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Derived from this study: PubMed 37307001Che X, Wang J, Sun W, He J, Wang Q, Zhu D, Zhu W, Zhang J, Dong J, Xu J, Zheng F, Zhou J, Zhao W, Lin Q, Ye L, Zhao X, Xu Z, Chen Y, Wang J, Wu W, Zhai L, Zhou Y, Zheng J, Zhang X. Effect of Mifepristone vs Placebo for Treatment of Adenomyosis With Pain Symptoms: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2317860. doi: 10.1001/jamanetworkopen.2023.17860.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mifepristone in people with Adenomyosis, run by xinmei zhang at 1 site in China.
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 8 inclusion and 13 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: finished, as of the sponsor's last update on 3 Oct 2019. 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 China. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
changes in chronic pelvic pain associated with adenomyosis (time frame: Baseline ,taking medicine for 1-month, 2-month, 3-month and post treatment 1- month（approximately 16 weeks）). 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 NCT03520439, which also lists 1 linked publication.
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 3 Oct 2019.