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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT05518812
Study groupRoleWhat they receive
HemabateExperimentalDilute 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.

  1. 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)
  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.

  1. First posted29 Aug 2022
  2. Study start12 Jul 2022
  3. Primary completion6 May 2024
  4. Study completion6 May 2024

Resources

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)
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

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.

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