Phase 2 Endometrial Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are female and between 18 and 55 years old at the time of signing consent.
• People with a body mass index (a measure of body weight relative to height) below 45.
• People who have been diagnosed with uterine fibroids (non-cancerous growths in the uterus) confirmed by ultrasound, in any number, located inside or within the wall of the uterus, with at least one fibroid larger than 3 cm across.
• People who have experienced heavy or prolonged menstrual bleeding during at least 3 of the last 6 periods, with cycles lasting between 22 and 35 days, including symptoms such as: needing double protection (e.g. both a tampon and a pad), a sensation of "gushing" or "flooding", soaking more than one tampon or pad per hour for 3 or more hours in a row, regularly needing to change protection during the night or soiling bedclothes, or bleeding that interferes with work, school, or daily life.
• People experiencing pelvic pain or pressure likely caused by fibroids.
• People who are already planning to have surgery to remove their uterus (hysterectomy) or their fibroids (myomectomy).
• People who have had a normal cervical screening (Pap smear) result within the past year.
• People who are using a non-hormonal method of contraception during the study, such as non-hormonal oral contraceptives, an intrauterine device (IUD), a barrier method (e.g. condoms), abstinence, or who have been sterilised.
• People who are able and willing to sign a written consent form.

Who may not be able to join:

• People who are currently pregnant or breastfeeding.
• People with a previous or current diagnosis of cancer of the uterus, cervix, or ovaries.
• People who currently have, or have a history of, abnormal thickening of the uterine lining (endometrial hyperplasia), particularly the atypical type.
• People where there is any suspicion of a cancerous fibroid (leiomyosarcoma).
• People whose fibroids have grown rapidly (roughly doubled in size within 1 to 6 months).
• People with unexplained vaginal bleeding, abnormal cervical cell changes, or an unexplained growth on the ovaries that has not been investigated.
• People who have already reached menopause.
• People for whom surgery is urgently needed within the next 3 months for medical or personal reasons.
• People with a very low haemoglobin level (a measure of red blood cells) of 6 g/dL or below.
• People who are currently participating in another clinical research study.
• People who have a mental health condition or any other barrier that would prevent them from giving informed written consent.
• People who have a known allergy or sensitivity to simvastatin (a type of cholesterol-lowering medication).
• People who are currently taking simvastatin or a medication in the same drug family (statins).
• People who are currently taking certain medications that interact with simvastatin, including specific antifungals, antibiotics, HIV medications, or heart medications — the full list should be confirmed with the trial site.
• People who are currently taking gemfibrozil, cyclosporin, danazol, or certain heart and blood pressure medications including verapamil, diltiazem, amiodarone, dronedarone, amlodipine, or ranolazine, or who regularly consume grapefruit juice (confirm with trial site).
• People with active liver disease or persistently elevated liver enzyme levels above a certain threshold at the time of screening.
• People with a known increased risk of, or a diagnosed condition affecting, muscle tissue (myopathy).

Important: Always verify eligibility with the trial site directly before applying.