AdenomyosisEarly Phase 1LUOMITTOANCT05151016
Long-term Use of Mifepristone in the Treatment of Adenomyosis
A Early Phase 1 study testing mifepristone and Triptorelin Acetate in people with Adenomyosis and Mifepristone, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial summary
The design was a prospective, randomized, positive-control, parallel-group, multicenter clinical trial. The study included a randomized, parallel-group treatment for 24 weeks in 140 subjects from eight hospitals in seven cities across the country who were diagnosed with Adenomyosis and associated symptoms… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Adenomyosis, Mifepristone
- What is being tested?
- mifepristone and Triptorelin Acetate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 31 Dec 2023
- Phase
- Early Phase 1
- 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
- Female, over 18 years old and not menopausal, agree to tripriline acetate and mifepristone treatment and informed consent
- Patients were diagnosed as adenomyosis by postoperative pathology, or those who did not undergo surgery but were diagnosed by auxiliary examination, such as ultrasonography and MRI.
- Dysmenorrhea with or Without Menorrhagia
- Requiring preservation of the uterus or fertility
- No other hormonal treatment for Adenomyosis was received in the three months prior to treatment
- Normal or non-clinically significant cervical cytology results (6 months before the screening period)
Who cannot join
- Pelvic pain and vaginal bleeding of unknown or non-Adenomyosis causes
- Benign Lesions such as endometrial polyp, submucous Myoma or suspicious malignant tumors were diagnosed by ultrasonography
- Receiving other hormone drugs for Adenomyosis
- Use other drugs that interact with tripriline acetate and mifepristone, and can not be stopped
- Patients with severe heart, liver, kidney disease and Adrenal insufficiency; drug allergy or allergic constitution
- Participated in other clinical trials within 3 months, and other factors considered unsuitable for the trial
- Pregnant, lactating women and those who prepare for childbirth during the treatment or within six months after treatment
- Postmenopausal women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Randomized Clinical Trial of Mifepristone Versus GnRHa for the Treatment of Adenomyosis
The design was a prospective, randomized, positive-control, parallel-group, multicenter clinical trial. The study included a randomized, parallel-group treatment for 24 weeks in 140 subjects from eight hospitals in seven cities across the country who were diagnosed with Adenomyosis and associated symptoms (dysmenorrhea, with or without heavy menstrual flow) , the subjects were randomly assigned to the following two groups:
- Study Group: mifepristone tablets, 10 mg, 1 tablet daily, taken orally (beginning on the third day of Menstruation) for 24 weeks;
- Control Group: dafinil (Triptorelin Acetate) , 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks.
- Conditions
- Adenomyosis, Mifepristone
- Being tested
- mifepristone, Triptorelin Acetate
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mifepristoneDrug
Mifepristone tablets, 10mg, 1 tablet daily, taken orally (beginning on the third day of Menstruation) for 24 weeks
Triptorelin AcetateDrug
dafinil, 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| mifepristone | Experimental | mifepristone tablets，10mg，One tablet daily, oral treatment Receives: Drug: mifepristone |
| Triptorelin Acetate | Active comparator | dafinil, 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks. Receives: Drug: Triptorelin Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Pain on the Visual Analogue Scale (VAS) at week 24
The VAS is the most commonly used instrument assessing pain in clinical practice. It reflects the patient's subjective perception of pain. Possible scores range from 0 (no pain) to 10 (worst possible pain). The last observation carry forward was used for missing data.
Change=(Week 24 Score - Baseline Score)
Measured: Baseline and Week 24
Secondary outcomes (4)
Pictorial blood loss assessment chart（PBAC）
Recording the use of tampons and sanitary towels by placing a tally mark under the day next to the box. Record clots by indicating whether they are the size of a 1p or 50pcoin in the clots/ flooding row under the relevant day. E.g. under day1 you may say 50p*1 and 1p*3. Record any incidences of flooding by placing a tally mark in the clots/ flooding row under the relevant day. A lightly stained towel (pic 1) will score 1 point, a moderately stained towel (pic 2) 5 points, a towel which is saturated with blood(pic 3) will score 20 points. A lightly stained tampon (pic 4) will score 1 point, a moderately stained tampon (pic 5) 5 points and a tampon that is fully saturated will score 10 points. A clot the size of 1p scores 1 point, a 50p sized clot scores 5 pointsand flooding also scores 5 points. Finally, total up the scores. A score of100 or greater may indicate a heavy period.
Change=Week 24 Score - Baseline Score
Measured: Baseline and week 24
Change from baseline in uterine size at week 24
Uterine size usually reflects the size of the adenomyosis lesion, and is measured in cubic centimeters.
Change=(Week 24 Uterine Size - Baseline Uterine Size)*0.5236
Measured: Baseline and week 24
Change from baseline in hemoglobin at week 24
Hemoglobin, measured in grams per liter, reflects a patient's level of menstrual blood loss.
Change=(Week 24 Hemoglobin Content - Baseline Hemoglobin Content)
Measured: Baseline and week 24
Change from baseline in CA125 at week 24
CA125 is measured in micrograms per liter. Change=(Week 24 Hemoglobin Content - Baseline Hemoglobin Content)
Measured: Baseline and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Dec 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo Women & Children's Hospital, Jiaxing Maternity and Child Health Care Hospital, The Affiliated Hospital of Medical School, Ningbo University, Qilu Hospital of Shandong University, Obstetrics & Gynecology Hospital of Fudan University, The First Affiliated Hospital with Nanjing Medical University, Anhui Provincial Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151016
- Sponsor's protocol ID
- 20210229
- Acronym
- LUOMITTOA
- Status last verified
- Nov 2021
- First submitted
- 7 Oct 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Clinical Trial of Mifepristone Versus GnRHa for the Treatment of Adenomyosis
- ClinicalTrials.gov ID
- NCT05151016
- Acronym / sponsor ID
- LUOMITTOA / 20210229
- Conditions
- Adenomyosis, Mifepristone
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Ningbo Women & Children's Hospital, Jiaxing Maternity and Child Health Care Hospital, The Affiliated Hospital of Medical School, Ningbo University, Qilu Hospital of Shandong University, Obstetrics & Gynecology Hospital of Fudan University, The First Affiliated Hospital with Nanjing Medical University, Anhui Provincial Hospital
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Dec 2021 (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.
The design was a prospective, randomized, positive-control, parallel-group, multicenter clinical trial. The study included a randomized, parallel-group treatment for 24 weeks in 140 subjects from eight hospitals in seven cities across the country who were diagnosed with Adenomyosis and associated symptoms (dysmenorrhea, with or without heavy menstrual flow) , the subjects were randomly assigned to the following two groups:
- Study Group: mifepristone tablets, 10 mg, 1 tablet daily, taken orally (beginning on the third day of Menstruation) for 24 weeks;
- Control Group: dafinil (Triptorelin Acetate) , 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mifepristone | Experimental | Drug: mifepristonemifepristone tablets，10mg，One tablet daily, oral treatment |
| Triptorelin Acetate | Active comparator | Drug: Triptorelin Acetatedafinil, 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female, over 18 years old and not menopausal, agree to tripriline acetate and mifepristone treatment and informed consent
- Patients were diagnosed as adenomyosis by postoperative pathology, or those who did not undergo surgery but were diagnosed by auxiliary examination, such as ultrasonography and MRI.
- Dysmenorrhea with or Without Menorrhagia
- Requiring preservation of the uterus or fertility
- No other hormonal treatment for Adenomyosis was received in the three months prior to treatment
Key exclusion criteria (8 listed)
- Pelvic pain and vaginal bleeding of unknown or non-Adenomyosis causes
- Benign Lesions such as endometrial polyp, submucous Myoma or suspicious malignant tumors were diagnosed by ultrasonography
- Receiving other hormone drugs for Adenomyosis
- Use other drugs that interact with tripriline acetate and mifepristone, and can not be stopped
- Patients with severe heart, liver, kidney disease and Adrenal insufficiency; drug allergy or allergic constitution
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 |
|---|---|---|
| mifepristoneMifepristone tablets, 10mg, 1 tablet daily, taken orally (beginning on the third day of Menstruation) for 24 weeks | Drug | mifepristone |
| Triptorelin Acetatedafinil, 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks. | Drug | Triptorelin Acetate |
Primary outcome
Change from Baseline in Pain on the Visual Analogue Scale (VAS) at week 24
Time frame: Baseline and Week 24
The VAS is the most commonly used instrument assessing pain in clinical practice. It reflects the patient's subjective perception of pain. Possible scores range from 0 (no pain) to 10 (worst possible pain). The last observation carry forward was used for missing data. Change=(Week 24 Score - Baseline Score)
4 secondary outcomes
Pictorial blood loss assessment chart（PBAC）
Time frame: Baseline and week 24
Change from baseline in uterine size at week 24
Time frame: Baseline and week 24
Change from baseline in hemoglobin at week 24
Time frame: Baseline and week 24
Change from baseline in CA125 at week 24
Time frame: Baseline and week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing mifepristone and Triptorelin Acetate in people with Adenomyosis and Mifepristone, run by Women's Hospital School Of Medicine Zhejiang University 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 Dec 2021. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinmei Zhang, M.D. ((+86)18957110072, zxm20130729@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Pain on the Visual Analogue Scale (VAS) at week 24 (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2021.