Fibroid UterusEarly Phase 1NCT05518812
Carboprost (Hemabate) for Fibroid Resection
A Early Phase 1 study testing Carboprost Tromethamine in people with Fibroid Uterus and Gynecologic Disease, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this research study is to determine if low-dose (i.e., a fraction of what is commonly used) carboprost (Hemabate) helps facilitate fibroid removal (myomectomy). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibroid Uterus, Gynecologic Disease, Leiomyoma, Uterine
- What is being tested?
- Carboprost Tromethamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2022to 6 May 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo myomectomy with a surgeon in the division of Minimally Invasive Gynecologic Surgery
- Ability to understand and the willingness to sign a written informed consent
Who cannot join
- If any oxytocic agents have been or will be administered prior to surgery
- History of renal and/or hepatic impairment
- Active cardiac disease, pulmonary disease, or pelvic inflammatory disease (PID)
- Anemia (Hgb < 7g/dL), diabetes mellitus, jaundice, or epilepsy
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University - Northwestern Medicine, Lavin Family Pavilion
Chicago, Illinois, 60611
About this study
Official title: Carboprost Tromethamine (Hemabate) for Resection of Fibroids-a Pilot Study
The purpose of this research study is to determine if low-dose (i.e., a fraction of what is commonly used) carboprost (Hemabate) helps facilitate fibroid removal (myomectomy).
Read the detailed description
Uterine fibroids, also known as leiomyomas, are estimated to affect over 80% of women by the time menopause begins. Many women are asymptomatic and remain undiagnosed, therefore the prevalence of the disease is likely underestimated. Leiomyomas are the most common neoplasms to affect women and can cause morbidities such as heavy menstrual bleeding (HMB) and infertility. According to the American College of Obstetricians and Gynecologists, one-fourth of the women with leiomyomas befit treatment, presenting with heavy or prolonged menstrual bleeding, abdominal protrusion, bowel or bladder dysfunction, infertility, recurrent pregnancy loss, painful menses, or pelvic pain. Risk factors associated with developing leiomyomas include: early menarche, use of oral hormonal contraceptives before the age of 16 years, African descent, and an increased body mass index (BMI) (StatPearls Leiomyoma). Factors that may lower the incidence of leiomyomas include: increased parity, use of depot medroxyprogesterone acetate (DMPA) or oral hormonal contraceptives for any duration.
Leiomyomas are benign tumors which arise from monoclonal smooth muscle cells of the uterus (StatPearls Leiomyoma); cells mostly composed of extracellular matrix and encapsulated in a pseudocapsule of areolar tissue. These tumor cells characteristically express higher levels of estrogen and progesterone receptors than normal myometrial cells, and ovarian steroids such as estradiol and progesterone enhance leiomyoma growth. Studies have shown that the size of leiomyomas decrease after menopause when ovarian steroid hormones decline. Leiomyoma cells typically exhibit a low mitotic index. Uterine leiomyomas can impact fertility in multiple ways, for instance, leiomyomas can impede sperm migration, interrupt ovum transport or embryo implantation, and can cause early pregnancy loss. Current treatment options for management of leiomyomas including medical therapies and surgical intervention.
Surgically resecting fibroids is one of the most common procedures performed for women of reproductive age. The goal of surgery is to mitigate symptoms and lower the risk of recurrence. Fibroids identified as FIGO 0 or 1 are typically resected completely at hysteroscopy. Unfortunately, fibroids categorized as FIGO 2 when approached hysteroscopically are almost never completely removed given that there can remain residual leiomyoma within the myometrium that is inaccessible. This commonly requires follow up procedures in the coming 6 months as the myometrial portion migrates into the cavity allowing it to be accessible hysteroscopically. Similarly at laparoscopy/laparotomy, FIGO 6 or 7 fibroids are easily resected completely without significant myometrial disruption. In contrast, FIGO 3-5 fibroids require a much more invasive approach into the myometrium, potentially increasing the risk of uterine rupture during pregnancy, a potentially life-threatening event. Techniques have been developed to promote intraoperative fibroid migration towards the access point (laparoscopy/laparotomy/hysteroscopy) with some success. This is a pilot study to determine whether intramural carboprost at low concentrations can facilitate fibroid migration and minimize the risk of carboprost-related side effects. Using carboprost intraoperatively is relatively simple, does not require additional instrumentation, and potentially results in a more complete resection, reducing operative times and re-operation. With the use of carboprost, the myoma is expelled due to the myometrial contraction, and the leiomyoma is shaved down to the myometrium surface, nullifying the need to deeply invade the myometrium.
- Conditions
- Fibroid Uterus, Gynecologic Disease, Leiomyoma, Uterine
- Being tested
- Carboprost Tromethamine
- Medical subject headings
- Leiomyoma, Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carboprost TromethamineDrug
Also called Hemabate
During myomectomy, low-dose carboprost will be injected at the base of the fibroid and repeated as necessary. The efficacy of low-dose carboprost is being assessed, and the total dose administered will not exceed single vial for other indications.
| Study group | Role | What they receive |
|---|---|---|
| Hemabate | Experimental | Dilute the 250mcg/mL vial with 25mL saline to create a solution of 10mcg/mL, and inject no more than 10mL of diluted solution at the base of the fibroid. The route of administration depends on the location of the fibroid. Receives: Drug: Carboprost Tromethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does instillation of low-dose carboprost facilitate complete resection of FIGO II fibroids during hysteroscopic resection?
Pre-operative and post-operative ultrasound will be compared to measure the residual fibroid after hysteroscopic resection with carboprost installation.
Measured: Pre-operatively to 1 month post-operatively
Secondary outcomes (1)
To quantitatively assess the efficiency of fibroid resection after carboprost administration by analyzing the video recording from surgery
Recordings of all gynecologic surgeries on the site are recorded. The study team members will download and de-identify recordings by removing any PHI and labeling the video with the study ID assigned to the patient by the study team. The video will be used to assess the efficiency of fibroid removal facilitated by low-dose carboprost. The amount of tissue and the time resected will be measured to determine the grams per minute compared to historical controls.
Measured: Through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start12 Jul 2022
- Primary completion6 May 2024
- Study completion6 May 2024
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 Fibroid UterusStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdy Milad, MD, Northwestern University
- Investigators
- Magdy p Milad, MD, MS, Principal investigator, Northwestern University, Northwestern Memorial Hopsital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518812
- Sponsor's protocol ID
- STU00216433
- Status last verified
- Sep 2024
- First submitted
- 5 Aug 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Cromack SC, Yu L, Milad MP. Prostaglandin Injection for Myoma Expulsion (PRIME): Case Series of a Novel Approach to Hysteroscopic Resection of FIGO Type 2 Myomas. J Minim Invasive Gynecol. 2024 Jul;31(7):613-619. doi: 10.1016/j.jmig.2024.03.011. Epub 2024 Apr 10.
PubMed 38604533
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carboprost Tromethamine (Hemabate) for Resection of Fibroids-a Pilot Study
- ClinicalTrials.gov ID
- NCT05518812
- Acronym / sponsor ID
- STU00216433
- Conditions
- Fibroid Uterus, Gynecologic Disease, Leiomyoma, Uterine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 29 Aug 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.
The purpose of this research study is to determine if low-dose (i.e., a fraction of what is commonly used) carboprost (Hemabate) helps facilitate fibroid removal (myomectomy).
Detailed description
Uterine fibroids, also known as leiomyomas, are estimated to affect over 80% of women by the time menopause begins. Many women are asymptomatic and remain undiagnosed, therefore the prevalence of the disease is likely underestimated. Leiomyomas are the most common neoplasms to affect women and can cause morbidities such as heavy menstrual bleeding (HMB) and infertility. According to the American College of Obstetricians and Gynecologists, one-fourth of the women with leiomyomas befit treatment, presenting with heavy or prolonged menstrual bleeding, abdominal protrusion, bowel or bladder dysfunction, infertility, recurrent pregnancy loss, painful menses, or pelvic pain. Risk factors associated with developing leiomyomas include: early menarche, use of oral hormonal contraceptives before the age of 16 years, African descent, and an increased body mass index (BMI) (StatPearls Leiomyoma). Factors that may lower the incidence of leiomyomas include: increased parity, use of depot medroxyprogesterone acetate (DMPA) or oral hormonal contraceptives for any duration.
Leiomyomas are benign tumors which arise from monoclonal smooth muscle cells of the uterus (StatPearls Leiomyoma); cells mostly composed of extracellular matrix and encapsulated in a pseudocapsule of areolar tissue. These tumor cells characteristically express higher levels of estrogen and progesterone receptors than normal myometrial cells, and ovarian steroids such as estradiol and progesterone enhance leiomyoma growth. Studies have shown that the size of leiomyomas decrease after menopause when ovarian steroid hormones decline. Leiomyoma cells typically exhibit a low mitotic index. Uterine leiomyomas can impact fertility in multiple ways, for instance, leiomyomas can impede sperm migration, interrupt ovum transport or embryo implantation, and can cause early pregnancy loss. Current treatment options for management of leiomyomas including medical therapies and surgical intervention.
Surgically resecting fibroids is one of the most common procedures performed for women of reproductive age. The goal of surgery is to mitigate symptoms and lower the risk of recurrence. Fibroids identified as FIGO 0 or 1 are typically resected completely at hysteroscopy. Unfortunately, fibroids categorized as FIGO 2 when approached hysteroscopically are almost never completely removed given that there can remain residual leiomyoma within the myometrium that is inaccessible. This commonly requires follow up procedures in the coming 6 months as the myometrial portion migrates into the cavity allowing it to be accessible hysteroscopically. Similarly at laparoscopy/laparotomy, FIGO 6 or 7 fibroids are easily resected completely without significant myometrial disruption. In contrast, FIGO 3-5 fibroids require a much more invasive approach into the myometrium, potentially increasing the risk of uterine rupture during pregnancy, a potentially life-threatening event. Techniques have been developed to promote intraoperative fibroid migration towards the access point (laparoscopy/laparotomy/hysteroscopy) with some success. This is a pilot study to determine whether intramural carboprost at low concentrations can facilitate fibroid migration and minimize the risk of carboprost-related side effects. Using carboprost intraoperatively is relatively simple, does not require additional instrumentation, and potentially results in a more complete resection, reducing operative times and re-operation. With the use of carboprost, the myoma is expelled due to the myometrial contraction, and the leiomyoma is shaved down to the myometrium surface, nullifying the need to deeply invade the myometrium.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemabate | Experimental | Drug: Carboprost TromethamineDilute the 250mcg/mL vial with 25mL saline to create a solution of 10mcg/mL, and inject no more than 10mL of diluted solution at the base of the fibroid. The route of administration depends on the location of the fibroid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled to undergo myomectomy with a surgeon in the division of Minimally Invasive Gynecologic Surgery
- Ability to understand and the willingness to sign a written informed consent
Key exclusion criteria (4 listed)
- If any oxytocic agents have been or will be administered prior to surgery
- History of renal and/or hepatic impairment
- Active cardiac disease, pulmonary disease, or pelvic inflammatory disease (PID)
- Anemia (Hgb < 7g/dL), diabetes mellitus, jaundice, or epilepsy
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 |
|---|---|---|
| Carboprost TromethamineAlso: HemabateDuring myomectomy, low-dose carboprost will be injected at the base of the fibroid and repeated as necessary. The efficacy of low-dose carboprost is being assessed, and the total dose administered will not exceed single vial for other indications. | Drug | Hemabate |
Primary outcome
Does instillation of low-dose carboprost facilitate complete resection of FIGO II fibroids during hysteroscopic resection?
Time frame: Pre-operatively to 1 month post-operatively
Pre-operative and post-operative ultrasound will be compared to measure the residual fibroid after hysteroscopic resection with carboprost installation.
1 secondary outcome
To quantitatively assess the efficiency of fibroid resection after carboprost administration by analyzing the video recording from surgery
Time frame: Through study completion, up to 2 years
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 19 Sep 2024.
- Derived from this study: PubMed 38604533Cromack SC, Yu L, Milad MP. Prostaglandin Injection for Myoma Expulsion (PRIME): Case Series of a Novel Approach to Hysteroscopic Resection of FIGO Type 2 Myomas. J Minim Invasive Gynecol. 2024 Jul;31(7):613-619. doi: 10.1016/j.jmig.2024.03.011. Epub 2024 Apr 10.
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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.
Magdy p Milad, MD, MS principal investigator
Northwestern University, Northwestern Memorial Hopsital
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 Carboprost Tromethamine in people with Fibroid Uterus and Gynecologic Disease, run by Northwestern University at 1 site 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 2 inclusion and 4 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 19 Sep 2024. 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 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?
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?
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?
Does instillation of low-dose carboprost facilitate complete resection of FIGO II fibroids during hysteroscopic resection? (time frame: Pre-operatively to 1 month post-operatively). 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 NCT05518812, 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 19 Sep 2024.