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New treatment option for Endometriosis
Official title The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06439524
What this study is testing
What is 40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate?
40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for endometriosis.
Also referred to as Relugolix Combination Therapy (Rel-CT), Myfembree.
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 investigator-initiated single-site clinical trial is to compare the overall quality of life of participants taking Relugolix combination therapy (Rel-CT) following excisional surgery for endometriosis to participants that do not take Rel-CT following the same surgery. Rel-CT is an FDA approved form of medical treatment for endometriosis.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Age ≥ 18 years
- Planning to undergo an elective laparoscopic or robotic procedure for known or suspected endometriosis
You likely can't join if
- -A known contraindication to REL-CT. Contraindications include:
- High risk of arterial, venous thrombotic, or thromboembolic disorder
- Pregnancy Known osteoporosis
- Current or history of breast cancer or other hormone-sensitive malignancies
- Known hepatic impairment or disease
- Undiagnosed abnormal uterine bleeding
See the full eligibility criteria
- Age ≥ 18 years
- Planning to undergo an elective laparoscopic or robotic procedure for known or suspected endometriosis
- -A known contraindication to REL-CT. Contraindications include:
- High risk of arterial, venous thrombotic, or thromboembolic disorder
- Pregnancy Known osteoporosis
- Current or history of breast cancer or other hormone-sensitive malignancies
- Known hepatic impairment or disease
- Undiagnosed abnormal uterine bleeding
- Known hypersensitivity to components of Rel-CT
- The patient did not discontinue hormonal suppression within the required timeline: Trans-Dermal, Oral Medication, Patch, or Vaginal Ring: day before surgery Intrauterine Device or Sub-Dermal Implant: removed at surgery...
- Primary language other than English/Spanish
- Interested in pregnancy within the 6 months following the surgical procedure.
- If pregnancy test performed during pre-surgical work up is positive, the patient will no longer be a candidate for endometriosis surgery and will therefore not be eligible for the study.
- Patients without histologic evidence of endometriosis following their surgical procedure will be removed from the study prior to receiving the study intervention.
- Patients who undergo a surgical intervention more invasive than the planned laparoscopic or robotic excisional surgery, such as open abdominal surgical repair, will be removed from the study prior to receiving the study...
The study team makes the final eligibility decision.
Where it's taking place
- Wynnewood, Pennsylvania, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wynnewood, Pennsylvania, 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.