Fibroids, Uterine study: Misoprostol Tabets
Official title Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy
ClinicalTrials.gov ID: NCT07286188
What this study is testing
What is Misoprostol Tablets?
An investigational drug being studied for its effect on fluid deficit during hysteroscopic myomectomy for fibroids. It is designed to cause uterine muscle contraction and cervical softening as a prostaglandin E1 analogue.
Also referred to as Misoprostol.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether misoprostol, given before surgery, lowers fluid loss compared to a pretend treatment.
- Who it's for
- You may be able to join if you have fibroids and will have a hysteroscopic myomectomy.
- What's involved
- You will take a small dose of misoprostol or a pretend pill before your surgery. The doctors will then perform the fibroid removal and measure how much fluid is used.
- Time commitment
- The study lasts only the day of your surgery, with no extra visits needed.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join if
- 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
You likely can't join if
- 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...
- Known active inflammatory bowel disease involving the rectum or other significant anorectal conditions that may interfere with safe rectal...
See the full eligibility 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
- 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...
- Known active inflammatory bowel disease involving the rectum or other significant anorectal conditions that may interfere with safe rectal administration of study medication.
The study team makes the final eligibility decision.
Where it is enrolling
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.