Phase 4 Ovarian 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 willing and able to sign a consent form agreeing to take part in the trial, in line with local rules and ethics requirements.
• People who are willing and able to give themselves injections of the trial medicine as required.
• People who are willing and able to follow all trial procedures for the full duration, including any lifestyle, diet, and exercise guidance provided.
• People who are willing and able to complete trial diaries and questionnaires throughout the study.
• Women aged 18 to 45 years who are able to become pregnant.
• Women who had their first period at least 3 years ago and have not yet reached menopause.
• People with a Body Mass Index (BMI) of 27 or higher (a measure of body weight relative to height).
• People who have been previously diagnosed with Polycystic Ovary Syndrome (PCOS), confirmed using a specific set of medical guidelines called the Rotterdam criteria.
• People who have irregular periods — meaning cycles shorter than 21 days, longer than 35 days, or fewer than 8 periods per year — either within the last 10 years (if currently using hormonal contraception) or over the past year (if not using hormonal contraception).
• People who have blood test results showing higher-than-normal levels of male hormones (androgens), and/or visible physical signs of excess male hormones (such as excess hair growth or acne).
• People who have never used hormonal contraception, or who have not used it in the 6 months before the screening visit, and who are willing to avoid hormonal contraception for the full trial duration and use barrier methods (such as condoms or diaphragms) instead during the 72-week treatment period and for 30 days after the last dose.

Who may not be able to join:

• People who are not legally able to make decisions for themselves, or who are unable to understand what participation in the trial involves.
• People with a physical or mental health condition that, in the treating doctor's judgement, could put them at risk, affect the trial results, or prevent full participation. (Note: people with depression or other stable psychiatric conditions may still be considered; however, anyone with a history of a suicidal event at any point in their life cannot be considered for inclusion.)
• People who are currently taking part in another clinical trial, or who have taken an investigational medicine in another trial within the 30 days before this trial's last dose.
• People with a known or ongoing problem with misuse of medicines, drugs, or alcohol.
• People with a current or untreated cancer diagnosis, or who have been in remission from a significant cancer for fewer than 5 years. (Certain skin cancers and early-stage cervical changes may be excluded from this rule — confirm with trial site.)
• People who have been diagnosed with severely reduced kidney function, or whose kidney function measured during screening falls below a specific threshold (eGFR less than 30 mL/min/1.73 m²).
• People with active or chronic hepatitis, signs of liver disease (other than fatty liver disease), or liver enzyme levels more than 3 times the upper limit of normal as measured during screening.
• People with a history of problems with stomach emptying, such as gastroparesis, gastric outlet obstruction, or long-term use of medicines that significantly slow stomach emptying.
• People who are currently pregnant (confirmed by a positive pregnancy test), who plan to become pregnant during the 72-week treatment period, or who are currently breastfeeding.
• People diagnosed with any form of diabetes other than Type 2 diabetes. (A past history of gestational diabetes — diabetes during pregnancy — does not apply to this exclusion.)
• People with Type 2 diabetes who are currently taking certain diabetes medicines including DPP-4 inhibitors, GLP-1 receptor agonists, or dual/triple incretin agonists within 6 months before screening, or who are on sulfonylureas or insulin, or whose diabetes is poorly controlled (HbA1c above 8.5%), or who have certain diabetes-related eye complications requiring urgent treatment. (Use of metformin or SGLT-2 inhibitors for blood sugar control in Type 2 diabetes is permitted.)
• People who have used a GLP-1 receptor agonist or dual incretin agonist medicine (for weight management or any other reason) within the 6 months before screening.
• People who have used inositol supplements within the 6 months before screening.
• People diagnosed with Congenital Adrenal Hyperplasia (CAH), a condition affecting hormone production in the adrenal glands.
• People with thyroid, pituitary, or adrenal gland conditions that are not adequately treated. (People with a stable, well-managed condition on a stable medicine dose for at least 12 weeks before screening may still be considered — confirm with trial site.)
• People with abnormally high levels of a hormone called prolactin (hyperprolactinaemia).
• People with a known history of non-cancerous growths inside the uterus.
• People who have had their uterus surgically removed (hysterectomy).
• People with a known allergy or sensitivity to the trial medicine tirzepatide or any of its ingredients.
• People with a known allergy or sensitivity to medroxyprogesterone acetate, dydrogesterone, or any ingredients in the supporting medicines used in the trial.
• People with a personal or family history of a specific type of thyroid cancer (medullary thyroid cancer), or a condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• People with elevated levels of a hormone called calcitonin in their blood, measured during screening, above certain thresholds depending on kidney function (confirm with trial site for specific values).
• People with a known secondary cause of obesity such as Cushing's syndrome, or a genetic condition causing obesity such as Prader-Willi Syndrome or melanocortin 4 receptor deficiency.
• People with a known history of acute or chronic inflammation of the pancreas (pancreatitis).
• People who have previously had, or are planning to have, weight-loss (bariatric) surgery or any device-based obesity treatment. (Cosmetic procedures such as liposuction or tummy tuck performed more than 1 year before screening may not apply — confirm with trial site.)
• People experiencing vaginal bleeding with no identified cause.
• People with a known history of blood clots (thromboembolic events) or active inflammation of a vein (thrombophlebitis).

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