Recruiting

Misoprostol

Sponsor:

Northwestern University

Code:

NCT07286188

Conditions

Fibroids, Uterine

Fluid Deficit

Hysteroscopy / Methods

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Misoprostol Tabets

Placebo

Study Details

Brief summary:

The goal of this double blinded randomized control trial is to evaluate the impact of misoprostol on fluid deficit during hysteroscopic myomectomies. The main questions it aims to answer are:

Is there is difference in fluid deficit in patients who receive misoprostol vs placebo pre operatively for hysteroscopic myomectomies?

Participants will be randomized to received 800 mcg of either rectal misoprostol prior to their hysteroscopic myomectomy or 4 tablets of placebo (ZEEBO) prior to their hysteroscopic myomectomy.

Conditions

Fibroids, Uterine

Fluid Deficit

Hysteroscopy / Methods

Study ID

NCT07286188

Start date

Dec 16, 2025

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients presenting for hysteroscopic myomectomy for uterine fibroids on pelvic imaging (pelvic ultrasound or MRI) within in last 12 months
  • Age ≥ 18 years and ≤ 50 years.
  • Fibroids between 1-3cm in size
  • Myomectomy using myosure or resectoscope devices
  • Willing to have rectal misoprostol or placebo at time of procedure
  • Ability to understand and the willingness to sign a written informed consent.
  • Admissible medical/surgical history.
  • Can be previously treated with Depo-Lupron, Depo-Provera, or Oral Contraceptive pills
  • Can have had prior Cesarean delivery

Exclusion Criteria:

  • Pregnancy. All patients will be required to have a negative urine pregnancy test prior to surgery.
  • Post-menopausal women.
  • Patients with a history of gynecologic malignancy.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to misoprostol.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Known active inflammatory bowel disease involving the rectum or other significant anorectal conditions that may interfere with safe rectal administration of study medication.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Misoprostol (treatment aem)

Patients will received 800 mcg of misoprostol per rectum prior to procedure.

placebo comparator: Zeebo (Placebo arm)

Patient will receive 4 tablets of placebo (ZEEBO) per rectum prior to procedure.

Interventions

Misoprostol Tabets

800 mcg of misoprostol will be administered per rectum to intervention group prior to their scheduled hysteroscopic myomectomy.

Placebo

4 tablets of Zeebo (Microcsrystalline cellulose) placebo tablets will be placed per rectum to prior to undergoing a hysteroscopic myomectomy, for patients assigned to the placebo arm.

Primary outcome measure

  • Fluid Deficit [ Time Frame: Immediately at the conclusion of the procedure. ]

Central Contacts and Locations

Central contacts

Hannah Pope, MD

3126946773hannah.pope@nm.org

Juan Avitia, MPH

juan.avitia1@nm.org

Locations

Northwestern

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Hannah Pope, MD

3126946773hannah.pope@nm.org

Juan Avitia, MPH

juan.avitia1@nm.org

More Information

Sponsor

Northwestern University

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

  • fibroids
  • hysteroscopy
  • myomectomy
  • fluid deficit
  • misoprostol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-06-01.