Tranexamic Acid and Depot-Medroxyprogesterone Acetate for Perimenopausal Irregular Uterine Bleeding (NCT04710017) | Clinical Trial Compass
CompletedNot Applicable
Tranexamic Acid and Depot-Medroxyprogesterone Acetate for Perimenopausal Irregular Uterine Bleeding
Egypt110 participantsStarted 2021-02-01
Plain-language summary
Abnormal uterine bleeding is a symptom and not a disease. It is one of the most frequently encountered complaints in gynecologic practice. It accounts for more than 70% of all gynecological consultations in the peri- and post-menopausal age group.
Abnormal uterine bleeding may be acute or chronic and is defined as bleeding from the uterine corpus that is abnormal in regularity, volume, frequency, or duration and occurs in the absence of pregnancy.
Chronic heavy or prolonged uterine bleeding can result in anemia, interfere with daily activities. Iron deficiency anemia develops in 21 to 67 percent of cases and raises concerns about uterine cancer.
According to the International Federation of Obstetrics and Gynecology, the classification of abnormal uterine bleeding is based on PALM-COEIN which is an acronym for various etiologies namely polyp, adenomyosis, leiomyoma, malignancy and hyperplasia, coagulopathy, ovulatory dysfunction, endometrial disorders, iatrogenic and not otherwise classified (PALM-COEIN).
Who can participate
Age range
40 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:
* Patients diagnosed, clinically as peri-menopausal abnormal uterine bleeding with normal pelvic examination.
* Patient's age ranging from 40- 55y.
Exclusion Criteria:
* Post menopausal women
* Presence of fibroids, adenomyosis, polyp, adnexal mass, endometrial hyperplasia with atypia, and breast malignancy).
* Patients with uncontrolled hypertension.
* Patient of abnormal bleeding profile.
* history of liver impairment and renal insufficiency
* Patients seeking for surgical management.
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.