GyneFix IUD Plus LNG-IUS for Adenomyosis (NCT07680985) | Clinical Trial Compass
CompletedNot Applicable
GyneFix IUD Plus LNG-IUS for Adenomyosis
China270 participantsStarted 2023-07-20
Plain-language summary
Adenomyosis is a common gynecological condition that can cause menstrual pain, heavy menstrual bleeding, anemia, and reduced quality of life. The levonorgestrel-releasing intrauterine system is commonly used as a conservative treatment, but displacement or expulsion of the device may occur, especially in patients with an enlarged uterus or a deep uterine cavity.
This study evaluated whether combining an Indomethacin-GyneFix intrauterine device with a levonorgestrel-releasing intrauterine system could improve device stability in patients with adenomyosis. Eligible participants were randomly assigned to receive GyneFix IUD plus LNG-IUS, ring IUD plus LNG-IUS, or LNG-IUS alone. Participants were followed for 6 months after device placement. The main outcome was device displacement or expulsion at 6 months. Other outcomes included menstrual pain, menstrual blood loss, uterine volume, hemoglobin, CA125, adverse events, and treatment acceptance.
Who can participate
Age range
20 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female patients aged 20 to 55 years.
* Diagnosed with adenomyosis by transvaginal ultrasound.
* No current desire for pregnancy and willing to receive conservative intrauterine treatment.
* No contraindications to intrauterine device placement.
* Able to understand the study procedures and voluntarily provide written informed consent.
* Able and willing to comply with scheduled follow-up visits and study assessments.
Exclusion Criteria:
* Pregnancy or suspected pregnancy.
* Concurrent malignant tumor of the reproductive system.
* Severe cervical lesions or uterine malformations.
* Severe coagulation disorder.
* Severe hepatic or renal insufficiency.
* Known hypersensitivity to levonorgestrel, copper, indomethacin, or related device components.
* Uncontrolled pelvic inflammatory disease or untreated vaginal infection.
* Uterine prolapse grade II or higher.
* Any condition judged by the investigator to make intrauterine device placement unsuitable.
* Inability to complete follow-up or incomplete key clinical data.
* Withdrawal of consent during the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.