Clinical trial

Carboprost Tromethamine (Hemabate) for Resection of Fibroids-a Pilot Study

Name

STU00216433

Description

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).

Trial arms

Trial start

2022-07-12

Estimated PCD

2024-07-01

Trial end

2024-07-01

Status

Recruiting

Phase

Early phase I

Treatment

Carboprost Tromethamine

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.

Arms:

Hemabate

Other names:

Hemabate

Size

Primary endpoint

Does instillation of low-dose carboprost facilitate complete resection of FIGO II fibroids during hysteroscopic resection?

Pre-operatively to 1 month post-operatively

Eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2023-11-07

1 organization

1 product

4 indications

Organization

Northwestern University

Product

Indication

Indication

Indication

Indication