Norethindrone Acetate vs. GnRH Agonist for Endometriosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments for endometriosis, a condition where tissue similar to the uterine lining grows outside the uterus, causing pain and other symptoms. Researchers aim to determine if norethindrone acetate (an oral medication) is as effective as the GnRH agonist Lupron Depot (an injectable medication) in reducing these symptoms and maintaining bone health. The trial also examines how these treatments affect cholesterol levels and overall quality of life. Women diagnosed with endometriosis who continue to experience symptoms after surgery, while being in good general health, might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but if you have been on hormone therapies like GnRH agonists, you must stop them and wait for a 'washout period' (time without taking certain medications) before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study tested Lupron Depot in women with endometriosis and uterine fibroids. It effectively treated these conditions but caused some side effects. Common side effects included hot flashes, pain at the injection site, and general discomfort. Some individuals experienced swelling, and men reported testicular shrinkage. More serious reactions, such as sudden allergic responses, occurred, particularly in those with asthma or sinus issues.
Research has shown that norethindrone acetate is used for endometriosis and other menstrual problems. It works by preventing the egg from fully developing each month. This medication is usually well-tolerated, but like all medications, it can have side effects, including changes in menstrual flow, headaches, and nausea. It is important to use it under a doctor's guidance, with regular check-ups.
Both treatments have been studied for safety, and each has a known list of side effects. While these side effects can occur, they are typically manageable with medical supervision.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for endometriosis because they offer different approaches to managing the condition. Lupron Depot is unique as it is administered intramuscularly and works by suppressing estrogen production, potentially reducing endometriosis symptoms more effectively. On the other hand, Norethindrone Acetate is taken orally and acts as a progestin, which can help alleviate symptoms by thinning the uterine lining. These options present alternatives to standard treatments like nonsteroidal anti-inflammatory drugs (NSAIDs) and oral contraceptives, offering potentially more targeted symptom relief.
What evidence suggests that this trial's treatments could be effective for endometriosis?
This trial will compare the effectiveness of Lupron Depot and Norethindrone Acetate (NA) for treating endometriosis. Studies have shown that Lupron Depot effectively reduces pelvic pain in people with endometriosis by lowering hormone levels that cause the growth of endometrial tissue. Various studies have proven this treatment safe and effective, helping relieve symptoms while also preventing bone loss. Meanwhile, Norethindrone Acetate (NA) has been found to reduce pain and shrink endometriomas, which are cysts caused by endometriosis. Research indicates that both treatments are effective, but they work in different ways to manage endometriosis symptoms. Participants in this trial will receive either Lupron Depot followed by NA or NA alone.36789
Who Is on the Research Team?
Ozgul Muneyyirci-Delale, M.D.
Principal Investigator
State University of New York - Downstate Medical Center
Are You a Good Fit for This Trial?
This trial is for pre-menopausal women over 18 with regular periods and diagnosed endometriosis, confirmed by surgery. They should be in good health, not have used certain hormone therapies recently, and agree to use double-barrier contraception. Women who are postpartum or lactating within the last 3 months, have significant abnormal lab results or Pap smears, low bone density, or a history of severe reactions to hormones are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Norethindrone Acetate (NA) or GnRH agonist (Lupron Depot) for 24 weeks, followed by NA for an additional 28 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, 9, and 12 months
What Are the Treatments Tested in This Trial?
Interventions
- Lupron Depot
- Norethindrone Acetate
Lupron Depot is already approved in United States, European Union, Canada, Japan for the following indications:
- Prostate cancer
- Endometriosis
- Uterine fibroids
- Precocious puberty
- Prostate cancer
- Endometriosis
- Uterine fibroids
- Precocious puberty
- Prostate cancer
- Endometriosis
- Uterine fibroids
- Precocious puberty
- Prostate cancer
- Endometriosis
- Uterine fibroids
- Precocious puberty
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
State University of New York - Downstate Medical Center
Collaborator