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New treatment option for Fibroids, Uterine
Official title Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy
ClinicalTrials.gov ID: NCT07286188
What this study is testing
What is Misoprostol Tabets?
Misoprostol Tabets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for fibroids, uterine.
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
- 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?
- 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's taking place
- 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 - 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?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.