Phase 4 Endometrial Cancer Trial, Recruiting

Written by an AI model from the 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 at least 21 years old and under 54 years old
• People who were identified as female on their birth certificate
• People who have had fibroids (uterine leiomyomata) confirmed by an ultrasound or MRI scan within the past 24 months
• People who have experienced fibroid-related symptoms — such as heavy menstrual bleeding, pelvic pressure or discomfort, bladder or bowel changes, or pain during sex — for at least the past 3 months
• People whose fibroid symptoms are at least moderate in severity, based on a specific symptom questionnaire score of 30 or higher (the UFS-QOL SSS)
• People who have had a menstrual period within the past 3 months
• People who agree to use a non-hormonal or barrier method of contraception (such as a copper IUD, condoms, or similar) during the study if having sexual activity with a male partner who has not had a vasectomy

Who may not be able to join:

• People whose screening scan shows any single fibroid measuring 10 cm or more across, or a uterus measuring 16 cm or more in length — or, if the most recent scan was 12–24 months ago, fibroids of 9 cm or more or a uterus of 15 cm or more (confirm with trial site)
• People whose scan shows only one fibroid that is smaller than 2 cm across
• People who have a fibroid that sits mostly inside the uterine cavity (more than 50% within the cavity, classified as FIGO Type 0 or Type 1)
• People who have visited an emergency room or been hospitalised for fibroid symptoms in the past 12 weeks
• People who have had fibroid surgery or a radiological procedure for fibroids in the past 12 weeks, or who are planning such a procedure in the next 24 weeks
• People who have been treated with certain hormone-based medications (GnRH agonists or antagonists) for fibroids — by injection in the past 12 weeks or by mouth in the past 4 weeks — or who plan to use these in the next 24 weeks
• People who are currently pregnant or breastfeeding, were pregnant or breastfeeding in the past 12 weeks, or are planning to become pregnant in the next 24 weeks
• People whose blood test at screening shows a haemoglobin level below 8 g/dL (indicating severe anaemia), or who have had a blood transfusion in the past 12 weeks
• People whose screening blood test shows an LDL cholesterol level of 190 mg/dL or higher
• People whose screening blood test shows an oestradiol (oestrogen) level below 30 pg/mL, which may suggest postmenopausal status
• People aged 45 or older who have irregular periods (cycles shorter than 21 days or longer than 38 days), bleeding that lasts more than 14 days, or bleeding between periods — unless a doctor has already assessed them and discussed a uterine lining biopsy to rule out abnormal cell growth
• People with a history of osteoporosis, based on a bone density scan showing a Z-score below -2.0 at the spine, hip, or femoral neck; a previous fracture considered to be related to bone fragility; or current use of certain bone-strengthening medications (such as bisphosphonates, calcitonin, teriparatide, or denosumab)
• People with a history of severe liver disease (specifically Child Pugh Class C cirrhosis)
• People with a current or previous diagnosis of breast cancer
• People whose screening scan shows an ovarian or adnexal (tissue near the ovary) finding rated as category 3, 4, or 5 on the O-RADS reporting system, indicating a finding that needs further evaluation
• People whose screening scan raises concern for a current cancer affecting the reproductive, urinary, or digestive system
• People who have previously had a serious allergic reaction or significant side effect from letrozole, any other aromatase inhibitor, or an ingredient in the placebo capsule used in this trial
• People who have used letrozole, another aromatase inhibitor, or a SERM medication in the past 4 weeks, or who plan to start one in the next 24 weeks
• People who have used oestrogen, progestin, or androgen therapies — taken by mouth, vaginally, or applied to the skin — in the past 4 weeks; or by injection in the past 12 weeks; or who plan to start any of these in the next 24 weeks
• People who have used certain medications that may interact unsafely with letrozole — including methadone, levomethadone, nintedanib, or thalidomide — in the past 4 weeks, or who plan to start these in the next 24 weeks
• People with any condition that the study investigators believe would make it difficult to complete the study, including an uncontrolled mental health condition, substance use issues, or an inability to complete study assessments in English (or Spanish, at sites that offer Spanish-language assessments)

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