Ongoing Clinical Trials for Uterine Leiomyoma
There are currently 2 ongoing clinical trials investigating new treatment approaches for uterine leiomyoma (also known as uterine fibroids, myoma, fibroma). These studies are taking place in France and the Netherlands, examining both medication and surgical options to reduce symptoms and improve quality of life for women affected by this condition.
Clinical trial locations
- France
- Netherlands
Study on Reducing Bleeding Risk in Fibroid Surgery Using Misoprostol for Patients Undergoing Myomectomy
This clinical trial, taking place in France, is investigating whether a medication called Misoprostol can help reduce blood loss during fibroid removal surgery. The study focuses on patients undergoing myomectomy, which is a surgical procedure to remove fibroids while preserving the uterus.
Who can participate: Women between 18 and 43 years old with symptomatic fibroids causing bleeding, pain, or difficulty getting pregnant are eligible. For laparoscopic surgery (performed through small incisions), the fibroid should be 10 cm or smaller, or there should be no more than 4 fibroids. For laparotomy (surgery through a larger incision), patients should have fibroids larger than 10 cm or more than 4 fibroids. The surgical technique must allow for a specific procedure involving placement of a clip on the uterine artery.
Who cannot participate: Women who are pregnant or breastfeeding, have allergies to the study medication, are taking medications that could interfere with the results, have participated in another recent clinical trial, or have significant health issues, mental health conditions, or a history of substance abuse are not eligible to join this study.
Study focus: The main goal is to measure how much blood is lost during surgery and compare results between patients taking Misoprostol and those receiving a placebo. Researchers will also monitor hemoglobin levels (a protein in red blood cells) before and after surgery, and at one month post-surgery. The length of hospital stay and any complications will also be tracked. Participants will be randomly assigned to receive either a single 400 microgram dose of Misoprostol or a placebo tablet before their surgery.
How Misoprostol works: Misoprostol is a prostaglandin analog that binds to specific receptors in the body, causing increased uterine contractions and helping to reduce bleeding during the surgical procedure.
Study Comparing Ulipristal Acetate and Surgery for Women with Symptomatic Uterine Fibroids
This study, conducted in the Netherlands, compares a medication called Ulipristal Acetate (marketed as Esmya 5 mg tablets) with standard surgical treatments for women experiencing symptoms from uterine fibroids. The trial runs for 24 months and aims to determine which approach better improves quality of life.
Who can participate: Pre-menopausal women over 18 years of age with symptomatic fibroids requiring surgical treatment are eligible. This includes women who need procedures such as hysterectomy (removal of the uterus), myomectomy (removal of fibroids), or uterine artery embolization (blocking blood supply to fibroids). Participants must have either found that conservative treatments like medication have not worked or prefer not to use them.
Who cannot participate: Men and women from vulnerable populations may not be eligible for this study.
Study focus: The primary goal is to assess changes in quality of life between women taking Ulipristal Acetate and those undergoing surgery. Participants will complete the Uterine Fibroid Symptom questionnaire at various intervals throughout the study. Researchers will monitor pain levels, social participation, sexual functioning, changes in fibroid size, menstrual bleeding patterns, and blood health including liver function. The study will also examine healthcare costs and any impact on work productivity. This comprehensive approach aims to identify which treatment is more effective and satisfactory for patients while tracking any side effects or complications.
How Ulipristal Acetate works: Ulipristal is a selective progesterone receptor modulator that alters the effects of the hormone progesterone in the body. By modulating progesterone activity, which is involved in the menstrual cycle, the medication can help reduce the size of fibroids and alleviate symptoms such as heavy menstrual bleeding and pelvic pain. Participants assigned to the medication group take one 5 mg tablet daily.
Summary
These two clinical trials represent different approaches to managing uterine leiomyoma. The French study focuses on surgical support, investigating whether Misoprostol can make fibroid removal surgery safer by reducing blood loss. The Netherlands study takes a broader view, comparing medical management with Ulipristal Acetate against traditional surgical options to determine which approach provides better long-term quality of life outcomes.
Both studies address important concerns for women with symptomatic fibroids. The French trial specifically targets women planning surgery and aims to reduce surgical complications, while the Dutch trial offers insights into whether medication can serve as an alternative to surgery for some patients. Together, these trials contribute to expanding treatment options and improving care for women affected by uterine fibroids.