MetrorrhagiaPhase 4SOULNCT05538689
Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL)
A Phase 4 study testing Myfembree Oral Product in people with Metrorrhagia and Pelvic Pain, run by University of Chicago at 6 sites in United States.
Trial summary
In this project, the proposition is that the use of daily dosed Myfembree ( a combination of relugolix with estradiol and norethindrone acetate), FDA-approved medication to treat heavy menses fibroid-related symptoms, has the potential to delay the recurrence of fibroid symptoms, prolong the improved quality of life… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metrorrhagia, Pelvic Pain, Menorrhagia
- What is being tested?
- Myfembree Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 Nov 2022to 24 Oct 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion Criteria (all inclusion criteria must have been met prior to randomization unless otherwise specified):
- Has voluntarily signed and dated the informed consent form prior to initiation of any screening or study-specific procedures
- Premenopausal female aged 18 years and older on the day of signing of the informed consent form
- Has a diagnosis of uterine fibroids that is confirmed by a pelvic ultrasound (transvaginal and/or transabdominal) performed during the screening period.
- Has at least one or more of the following symptoms:
- Heavy menses defined as PBAC (Pictorial Bleeding Assessment Chart) score ≥ 120
Show all 54Show fewer
- Pelvic pain during menses measured on NRS (Numeric Pain Rating Scale) ≥ 4 at baseline
- Moderately severe fibroid-related symptoms (a score ≥ 25 on the Uterine Fibroid UF quality of life symptoms severity subscale)
- Has a negative urine pregnancy test at the Screening, Baseline and interval clinic visits
- Agrees to not be pregnant for at least 12 months. Participant may use any form of non-hormonal contraception consistently during the screening period . These may include: Diaphragm, cervical cap, spermicides, male and female condoms, copper IUD ( intra uterine device) and sponge. Each one will be explained in detail for the participants. However, the patient is not required to use dual contraception if she:
- Has a sexual partner(s) who was vasectomized at least 6 months prior to the screening period.
- Had a bilateral tubal occlusion (including ligation and blockage methods such as Essure™), at least 4 months prior to the first screening visit (patients with Essure™ must have prior confirmation of tubal occlusion by hysterosalpingogram);
- Is not sexually active with men; periodic sexual relationship(s) with men requires the use of dual non-hormonal contraception as noted above; or
- Practices total abstinence from sexual intercourse as her preferred lifestyle; periodic abstinence is not acceptable.
- Has an endometrial (aspiration) biopsy, if clinically indicated, performed during the screening period, with results showing no clinically significant endometrial pathology (hyperplasia, endometritis, or endometrial cancer).
- Exclusion Criteria: Participants who choose not to undergo randomization and instead opt for the parallel group, selecting the standard of care (SOC) arm, are exempted from meeting the exclusion criteria (4-5-6-7-8(C\&D)-9-11-12) specified for the study drug.
- Has transvaginal and/or transabdominal ultrasound during the screening period demonstrating pathology other than uterine fibroids that could be responsible for or contributing to the patient's heavy menstrual bleeding, such as uterine or cervical polyps > 2.0 cm, or any other clinically significant gynecological disorder determined by the investigator to require further evaluation and/or treatment.
- Note: Saline or gel contrast is not routinely required. Use of such contrast is required only when the endometrium cannot be evaluated or when there are ambiguous and potentially exclusionary findings on the transvaginal and/or transabdominal ultrasound (e.g., suspected intrauterine masses, equivocal endometrial findings, etc.)
- Has unexplained vaginal bleeding outside of the patient's regular menstrual cycle
- Has undergone ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance-guided focused ultrasound for fibroids, as well as endometrial ablation for abnormal uterine bleeding within 6 months prior to the Screening visit
- Has a history of or currently has osteoporosis, or other metabolic bone disease, hyperparathyroidism, hyperprolactinemia, hyperthyroidism, anorexia nervosa, or low traumatic (from the standing position) or atraumatic fracture (toe, finger, skull, face, and ankle fractures are allowed). A history of successfully treated hyperparathyroidism, hyperprolactinemia, or hyperthyroidism is allowed if the patient's bone mineral density is within normal limits
- Has a history of the use of bisphosphonates, calcitonin, calcitriol, ipriflavone, teriparatide, denosumab, or any medication other than calcium and vitamin D preparations to treat bone mineral density loss
- Anticipated use of systemic glucocorticoids at an oral prednisone-equivalent dose of more than 5 mg every other day during the study. Note: topical, inhaled, intranasal, optic, ophthalmic, intraarticular, or intralesional subcutaneous are permitted without restriction
- Gastrointestinal disorder affecting absorption or gastrointestinal motility
- Has any additional contraindication to treatment with low-dose estradiol and norethindrone acetate, including:
- Current, known, suspected, or history of breast cancer
- Current, known, or suspected hormone -dependent neoplasia
- High risk of arterial, venous thrombotic disorder or thromboembolic disorder
- women over 35 years of age who smoke or women with uncontrolled hypertension
- Active thrombotic or thromboembolic disease or history of these conditions prior to the Baseline Day 1 visit or risk factors for such conditions. These conditions include: i. deep vein thrombosis ii. pulmonary embolism iii. vascular disease (e.g., cerebrovascular disease, coronary artery disease, peripheral vascular disease) iv. inherited or acquired hypercoagulopathies, known protein C, protein S, or antithrombin deficiency, or other known thrombophilia disorders, including Factor V Leiden thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) v. uncontrolled hypertension vi. headaches with focal neurological symptoms or migraine headaches with aura if over 35 years of age vii. Women at increased risks for thrombotic or thromboembolic events
- Known anaphylactic reaction or angioedema or hypersensitivity to estradiol or norethindrone acetate
- Currently pregnant or lactating, or intends to become pregnant or to donate ova during the study period or within 1 month after the end of the study
- Has jaundice or known current active liver disease from any cause, including hepatitis A (HAV IgM), hepatitis B (HBsAg), or hepatitis C (HCV Ab positive, confirmed by HCV RNA);
- Has any of the following cervical pathology: high grade cervical neoplasia, atypical glandular cells, atypical endocervical cells, atypical squamous cells favoring high grade. Of note, patients with atypical squamous cells of undetermined significance and low-grade cervical neoplasia may be included in the study if high risk human papilloma virus testing is negative or if DNA testing for human papilloma virus 16 and 18 DNA testing is negative
- Has any of the following clinical laboratory abnormalities indicating hepatic or gallbladder impairment:
- Alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN), or bilirubin (total bilirubin) > 1.5 x ULN on clinical laboratory testing at either the Screening 1 or Screening 2 visit (or > 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome);
- Estimated glomerular filtration rate < 60 mL/min/m2 using the Modification of Diet in Renal Disease method
- Has clinically significant cardiovascular disease including:
- Prior history of myocardial infarction
- History of angina
- History of congestive heart failure
- History of clinically significant ventricular arrhythmias such as ventricular tachycardia, ventricular fibrillation, or torsade de pointes, or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place or untreated supraventricular tachycardia (heart rate ≥ 120 beats per minute)
- QT interval by the Fridericia correction formula (QTcF) of > 470 msec
- Hypotension, as indicated by systolic blood pressure < 84 millimeters of mercury (mmHg) on 2 repeat measures at least 15 minutes apart or treated ongoing symptomatic orthostatic hypotension with > 20 mmHg decrease in systolic blood pressure one minute or more after assuming an upright position.
- Uncontrolled hypertension, as indicated by systolic blood pressure > 160 mmHg on 2 repeat measures at least 15 minutes apart or diastolic blood pressure > 100 mmHg at any screening visit or the Baseline Day 1 visit.
- Bradycardia as indicated by a heart rate of < 45 beats per minute on the screening electrocardiogram.
- Has been a participant in an investigational drug or device study within the 1 month prior to Screening visit.
- Has a history of clinically significant condition(s) including, but not limited to:
- Untreated thyroid dysfunction or palpable thyroid abnormality (patients with adequately treated hypothyroidism who are stable on medication are not excluded).
- History of malignancy within the past 5 years or ongoing malignancy other than curatively treated nonmelanoma skin cancer or surgically cured Stage 0 in situ melanoma
- Any current psychiatric disorder that would, in the opinion of the investigator or medical monitor, impair the ability of the patient to participate in the study or would impair interpretation of their data. Patients with major depression, post-traumatic stress disorder, bipolar disorder, schizophrenia, or other psychotic disorders, based on Diagnostic and Statistical Manual of Mental Disorders-5 criteria who have been unstable based on the investigator's or mental health professional's judgement or whose psychiatric drug regimen has changed during the 3 months prior to Screening or is expected to change during the study should not be enrolled. Has a contraindication or history of sensitivity to any of the study treatments or components thereof; or has a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates study participation
- Has a prior (within 1 year of Screening 1 visit) or current history of drug or alcohol abuse disorder according to Diagnostic and Statistical Manual of Mental Disorders V (all patients must be questioned about their drug and alcohol use, and this should be documented in the electronic case report form)
- Has participated in a previous clinical study that included the use of Relugolix or has received this treatment within 3 months of the study.
- Is inappropriate for participation in this study for other reasons, as determined by the investigator, sub-investigator, or medical monitor.
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Chicago South Loop
Chicago, Illinois, 60607
University of Chicago River East
Chicago, Illinois, 60611
University of Chicago DCAM
Chicago, Illinois, 60637
University of Chicago Flossmoor
Flossmoor, Illinois, 60422
University of Chicago Orland Park
Orland Park, Illinois, 60462
University of Chicago Schererville
Schererville, Indiana, 46375
About this study
Official title: Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial.
In this project, the proposition is that the use of daily dosed Myfembree ( a combination of relugolix with estradiol and norethindrone acetate), FDA-approved medication to treat heavy menses fibroid-related symptoms, has the potential to delay the recurrence of fibroid symptoms, prolong the improved quality of life and delay the need for re-intervention after uterine sparing surgery versus the routine standard of care.
- Conditions
- Metrorrhagia, Pelvic Pain, Menorrhagia, Leiomyoma
- Being tested
- Myfembree Oral Product
- Medical subject headings
- Metrorrhagia, Pelvic Pain, Menorrhagia, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myfembree Oral ProductDrug
The study drug Myfembree will be taken orally with water, once daily, at approximately the same time, with or without food. Each tablet of Myfembree contains Relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5 mg.
| Study group | Role | What they receive |
|---|---|---|
| Study drug Myfembree | Experimental | Participants will be asked to take a once-daily tablet of Myfembree ( relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for 24 months. Receives: Drug: Myfembree Oral Product |
| Standard of Care | No intervention | The standard of care will depend on the participant's type of surgery, health history, and clinical symptoms. It often includes pain management, bleeding management, physical exams, pelvic ultrasound, birth control, and Surgical reintervention. |
| Parallel group for participants who opt not to be randomized | Other | patients who do not consent to randomization or opt to be in a specific group will be included in a parallel observational study and be administered their preferred treatment. Receives: Drug: Myfembree Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibroid recurrence on ultrasound after myomectomy.
Fibroid recurrence when compared to the post-myomectomy baseline pelvic ultrasound (transvaginal and/or transabdominal), defined as a new fibroid identified on ultrasound with a volume >1 cm3.
Measured: 36 months
Secondary outcomes (6)
Participants' quality of life assessed by the Quality of Life Questionnaire.
The Quality of life questionnaire: UFS-QOL ( Uterine Fibroid symptoms \& Health Related-Quality of Life) is a self-reported questionnaire used to measure symptoms and health-related quality of life in women with uterine fibroids. The questionnaire contains 8 items concerning uterine fibroid symptoms and 29 items concerning health-related quality of life. Each item has a score (1-5), and the scores are summed so that a higher score indicates a higher quality of life.
Measured: 36 months
Work Productivity and Activity Impairment assessed by Work Productivity and Activity Impairment Questionnaire.
The Work Productivity and Activity Impairment Questionnaire( WPAI: SHP) is a self-reported questionnaire assessing the effects of a participant's problem on her ability to work and perform activities on a scale from 0 (problem had no effect on daily activities) to 10 ( problem completely prevent doing daily activities).
Measured: 36 months
Female Sexual Function Impairment assessed by Female Sexual Function Index Questionnaire.
The Female Sexual Function Index (FSFI) is a self-reported questionnaire that assesses different domains of sexual function in addition to providing an overall score regarding sexual function. The possible total score ranges from 2 to 36.
Measured: 36 months
Heavy menses recurrence after myomectomy with score ≥ 120 on Pictorial Bleeding Assessment Chart (PBAC).
The Pictorial Bleeding Assessment Chart is a visual scoring system where the participant can directly record the number of her used feminine items (tampons and pads) and the degree to which they are bloodstained.
Measured: 36 months
Pelvic pain recurrence after myomectomy with Numerical Rating Scale (NRS) ≥ 4 at baseline.
The Numerical Rating Scale is a subjective measure in which participants rate their pain on an eleven-point. Possible scores range from 0(no pain) to 10 (worst possible pain).
Measured: 36 months
The need for surgical/non-surgical reintervention for recurrent symptoms after myomectomy reported by the participant and based on her provider's decision.
This will be measured based on the participant's reported symptoms and response to treatment. The re-intervention may include repeat myomectomy, uterine fibroid embolization, radiofrequency ablation, or hysterectomy.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start20 Nov 2022
- Primary completion24 Oct 2024
- Study completion24 Oct 2024
Why it stopped: Data not collected and analyzed; withdrawn due to lack of bandwidth.
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 MetrorrhagiaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Myovant Sciences GmbH
- Responsible party
- Sponsor
- Investigators
- Obianuju Sandra Madueke Laveaux, MD MPH, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538689
- Sponsor's protocol ID
- IRB22-0282
- Acronym
- SOUL
- Status last verified
- Sep 2025
- First submitted
- 7 Sep 2022
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alkhrait S, Al-Hendy A, Alkelani H, Karrison T, Laveaux OSM. Surgical myomectomy followed by oral Myfembree vs standard of care (SOUL trial): Study protocol for a randomized control trial. PLoS One. 2024 Jul 2;19(7):e0306053. doi: 10.1371/journal.pone.0306053. eCollection 2024.
PubMed 38954680
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial.
- ClinicalTrials.gov ID
- NCT05538689
- Acronym / sponsor ID
- SOUL / IRB22-0282
- Conditions
- Metrorrhagia, Pelvic Pain, Menorrhagia, Leiomyoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Data not collected and analyzed; withdrawn due to lack of bandwidth.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Myovant Sciences GmbH
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 14 Sep 2022 (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.
In this project, the proposition is that the use of daily dosed Myfembree ( a combination of relugolix with estradiol and norethindrone acetate), FDA-approved medication to treat heavy menses fibroid-related symptoms, has the potential to delay the recurrence of fibroid symptoms, prolong the improved quality of life and delay the need for re-intervention after uterine sparing surgery versus the routine standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study drug Myfembree | Experimental | Drug: Myfembree Oral ProductParticipants will be asked to take a once-daily tablet of Myfembree ( relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for 24 months. |
| Standard of Care | No intervention | –The standard of care will depend on the participant's type of surgery, health history, and clinical symptoms. It often includes pain management, bleeding management, physical exams, pelvic ultrasound, birth control, and Surgical reintervention. |
| Parallel group for participants who opt not to be randomized | Other | Drug: Myfembree Oral Productpatients who do not consent to randomization or opt to be in a specific group will be included in a parallel observational study and be administered their preferred treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (54 listed)
- Inclusion Criteria (all inclusion criteria must have been met prior to randomization unless otherwise specified):
- Exclusion Criteria: Participants who choose not to undergo randomization and instead opt for the parallel group, selecting the standard of care (SOC) arm, are exempted from meeting the exclusion criteria (4-5-6-7-8(C\&D)-9-11-12) specified for the study drug.
- Has transvaginal and/or transabdominal ultrasound during the screening period demonstrating pathology other than uterine fibroids that could be responsible for or contributing to the patient's heavy menstrual bleeding, such as uterine or cervical polyps > 2.0 cm, or any other clinically significant gynecological disorder determined by the investigator to require further evaluation and/or treatment.
- Note: Saline or gel contrast is not routinely required. Use of such contrast is required only when the endometrium cannot be evaluated or when there are ambiguous and potentially exclusionary findings on the transvaginal and/or transabdominal ultrasound (e.g., suspected intrauterine masses, equivocal endometrial findings, etc.)
- Has unexplained vaginal bleeding outside of the patient's regular menstrual cycle
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Myfembree Oral ProductThe study drug Myfembree will be taken orally with water, once daily, at approximately the same time, with or without food. Each tablet of Myfembree contains Relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5 mg. | Drug | Parallel group for participants who opt not to be randomized, Study drug Myfembree |
Primary outcome
Fibroid recurrence on ultrasound after myomectomy.
Time frame: 36 months
Fibroid recurrence when compared to the post-myomectomy baseline pelvic ultrasound (transvaginal and/or transabdominal), defined as a new fibroid identified on ultrasound with a volume >1 cm3.
6 secondary outcomes
Participants' quality of life assessed by the Quality of Life Questionnaire.
Time frame: 36 months
Work Productivity and Activity Impairment assessed by Work Productivity and Activity Impairment Questionnaire.
Time frame: 36 months
Female Sexual Function Impairment assessed by Female Sexual Function Index Questionnaire.
Time frame: 36 months
Heavy menses recurrence after myomectomy with score ≥ 120 on Pictorial Bleeding Assessment Chart (PBAC).
Time frame: 36 months
Pelvic pain recurrence after myomectomy with Numerical Rating Scale (NRS) ≥ 4 at baseline.
Time frame: 36 months
The need for surgical/non-surgical reintervention for recurrent symptoms after myomectomy reported by the participant and based on her provider's decision.
Time frame: 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Derived from this study: PubMed 38954680Alkhrait S, Al-Hendy A, Alkelani H, Karrison T, Laveaux OSM. Surgical myomectomy followed by oral Myfembree vs standard of care (SOUL trial): Study protocol for a randomized control trial. PLoS One. 2024 Jul 2;19(7):e0306053. doi: 10.1371/journal.pone.0306053. eCollection 2024.
- Individual participant dataSharing planned: No
Related trials for Metrorrhagia
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Enrolling by invitationPhase 1
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
Abnormal Uterine Bleeding, Analgesia
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Recruiting
Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
Postmenopausal Women, Intrauterine Diseases
RecruitingObservational study
A Study on Abnormal Menstrual Bleeding in Chinese Women of Childbearing Age Taking Antithrombotic Drugs After Cardiovascular Surgery
Uterine Hemorrhage, Cardiovascular Diseases
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.
Obianuju Sandra Madueke Laveaux, MD MPH principal investigator
University of Chicago
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Myfembree Oral Product in people with Metrorrhagia and Pelvic Pain, run by University of Chicago at 6 sites in United States.
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 54 inclusion and 0 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: withdrawn, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
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 withdrawn before enrolling participants, so there are no results.
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?
Fibroid recurrence on ultrasound after myomectomy. (time frame: 36 months). 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 NCT05538689, 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 5 Jun 2026.