Carboprost (Hemabate) for Fibroid Resection

NCT05518812 | Completed Early Phase 1 FDA Drug

• 1 other identifier: STU00216433
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Fibroid Uterus; Gynecologic Disease; Leiomyoma, Uterine

Outcome Measures

Primary Outcomes (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.

  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

  Through study completion, up to 2 years

Study Arms (1)

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.

Drug: Carboprost Tromethamine

Interventions

Carboprost Tromethamine DRUG

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.

Also known as: Hemabate

Hemabate

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University - Northwestern Medicine, Lavin Family Pavilion

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Leiomyoma; Genital Diseases, Female

Interventions

carboprost tromethamine

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Magdy p Milad, MD, MS

  Northwestern University, Northwestern Memorial Hopsital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Minimally Invasive Gynecologic Surgery in the Department of Obstetrics and Gynecology Albert B. Gerbie, MD, Professor of Obstetrics and Gynecology Professor of Obstetrics and Gynecology (Minimally Invasive Gynecologic Surgery)

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 29, 2022
• Study Start: July 12, 2022
• Primary Completion: May 6, 2024
• Study Completion: May 6, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)