Phase 2 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 have voluntarily signed and dated a consent form before any screening procedures begin.
• Premenopausal women aged 18 or older at the time of signing the consent form.
• People who have a confirmed diagnosis of uterine fibroids, shown by a pelvic ultrasound done during the screening period.
• People who have at least one of the following symptoms: moderate to heavy periods (based on a specific bleeding score), pelvic pain during periods rated 4 or higher on a pain scale, or moderately severe fibroid-related symptoms based on a quality-of-life questionnaire score.
• People who have a negative pregnancy test at the screening visit, the baseline visit, and during check-in visits throughout the trial.
• People who agree not to become pregnant for at least 12 months, and who either use a non-hormonal method of contraception (such as condoms, a copper IUD, diaphragm, or spermicide), or who meet certain exceptions — such as having a partner who had a vasectomy at least 6 months before screening, having had a permanent tubal procedure at least 4 months before screening, not being sexually active with men, or practising complete abstinence as a consistent lifestyle choice.
• People who, if clinically recommended, had an endometrial (uterine lining) biopsy during screening that showed no significant abnormalities such as abnormal cell growth or cancer.

Who may not be able to join:

• People with a documented vitamin D deficiency based on a blood test within the past 12 months.
• People whose ultrasound shows conditions other than fibroids that could be causing or contributing to heavy bleeding, such as polyps larger than 2 cm or other significant gynaecological disorders requiring further assessment.
• People who have unexplained vaginal bleeding outside of their regular menstrual cycle.
• People who have had a surgical or non-surgical procedure to treat fibroids or abnormal uterine bleeding (such as radiofrequency ablation, uterine artery embolization, focused ultrasound, or endometrial ablation) within 6 months before screening.
• People with a history of or current osteoporosis, certain bone or hormonal conditions (such as hyperparathyroidism, hyperthyroidism, hyperprolactinemia, or anorexia nervosa), or a history of low-impact or unexplained bone fractures (note: certain previously treated conditions may be permitted if bone density is within normal range — confirm with trial site).
• People who have previously used certain bone-density medications such as bisphosphonates, teriparatide, or denosumab (calcium and vitamin D supplements are permitted).
• People who are expected to use systemic steroid medications (such as oral prednisone at doses above a specified level) during the study period (note: topical, inhaled, or other localised steroid forms are permitted).
• People with a gastrointestinal condition that affects how the body absorbs or moves food and medication through the digestive system.
• People with jaundice or an active liver disease, including active hepatitis A, B, or C.
• People with certain cervical abnormalities detected on screening (some lower-risk findings may still be eligible depending on additional test results — confirm with trial site).
• People with a history of laboratory results indicating liver or gallbladder problems.
• People who have taken part in a clinical trial of an investigational drug or device within 1 month before screening.
• People with untreated thyroid problems or a noticeable thyroid abnormality (people with treated and stable hypothyroidism may still be eligible).
• People with a history of cancer in the past 5 years, or ongoing cancer, other than certain types of fully treated skin cancer.
• People with a current psychiatric condition that, in the investigator's judgement, would affect their ability to participate or the reliability of their data — particularly those with unstable or recently changed treatment for conditions such as major depression, bipolar disorder, PTSD, schizophrenia, or other psychotic disorders in the 3 months before screening.
• People with a known allergy or sensitivity to any of the study treatments or their components.
• People with a history of drug or alcohol use disorder within the past year, as defined by standard diagnostic criteria.
• People who have participated in a previous clinical study involving green tea or Vitamin D3, or who have used these treatments within 3 months before the study.
• People whom the investigator, sub-investigator, or medical monitor considers unsuitable for participation for any other reason.

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