Phase 3 Obesity 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 aged between 18 and 45 years old
• People with a body mass index (BMI) of 24 or higher (a measure of body weight relative to height)
• People who have given written, informed consent to participate
• People who have been confirmed by tissue testing to have a condition called endometrial atypical hyperplasia (an abnormal thickening of the uterine lining), diagnosed through a uterine biopsy, scraping procedure, or camera examination of the uterus — if the testing was done at another hospital, the results must be reviewed or confirmed by the pathology department at the Obstetrics and Gynecology Hospital of Fudan University
• People who have a strong wish to preserve their fertility or keep their uterus, even if they do not plan to have children
• People who are willing and able to attend follow-up appointments at the Obstetrics and Gynecology Hospital of Fudan University as required

Who may not be able to join:

• People with serious medical conditions, or significant liver or kidney problems (specifically, certain liver enzyme levels three or more times above normal, or reduced kidney filtering ability)
• People who have been diagnosed with another cancer of the reproductive system, or who have breast cancer or another hormone-sensitive cancer that cannot safely be treated alongside progesterone-based therapy
• People who have taken high-dose hormonal contraceptives or high-potency progestins within the last three months, or who are currently taking them
• People whose condition requires surgical removal of the uterus or a treatment approach other than conservative (non-surgical) management
• People who are known or suspected to be pregnant
• People who have medical reasons that prevent them from safely using progestin-based treatment
• People who have a history of deep vein thrombosis (blood clots in the legs), stroke, or heart attack
• People with severe joint problems that prevent them from walking or moving
• People with untreated or recurring pelvic inflammatory disease
• People with an untreated or uncontrolled infection of the vagina, cervix, or uterus
• People with abnormal cell changes on the cervix (cervical dysplasia)
• People with uterine structural abnormalities present from birth or developed over time, including fibroids that change the shape of the uterine cavity
• People with a known allergy to the components of the LNG-IUS device (a hormone-releasing intrauterine device used in this trial) (confirm with trial site)
• People whose uterine cavity is considered too large (average uterine diameter over 7 cm) or who have a history of the LNG-IUS device falling out

Note: The last six criteria listed above apply only to participants who would be receiving the LNG-IUS device as part of this trial.

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