Levofloxacin with Metronidazole Suppositories for Chronic Endometritis
Levofloxacin Plus Metronidazole Suppositories
+ Levofloxacin co-administered with Metronidazole tablets
Treatment Study
Summary
Study start date: October 22, 2024
Actual date on which the first participant was enrolled.Chronic endometritis is a condition where the lining of the uterus becomes inflamed, often due to infections. This inflammation can lead to difficulties in getting pregnant, miscarriages, and issues with carrying a pregnancy to term. Current treatments usually involve taking antibiotics by mouth, but these can have side effects like nausea and skin rashes, and sometimes they don't work as well as hoped. This study is looking at whether treating the condition with a combination of levofloxacin and metronidazole in different forms might be more effective. The researchers are testing if using metronidazole as a suppository, which is inserted into the vagina, can deliver the medicine more directly to the problem area and improve pregnancy outcomes for women with this condition. In this study, participants are randomly assigned to receive either the standard treatment of oral levofloxacin and metronidazole tablets or a combination of levofloxacin with metronidazole suppositories. The focus is on women aged 20 to 42 who have been diagnosed with chronic endometritis through specific medical procedures. By comparing the pregnancy success rates between these two groups, the study aims to find a better treatment method that could help improve the chances of getting pregnant and having a successful birth. Participants need to have certain health criteria met, and those with other specific medical conditions or allergies to the medications used are not included in the study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.800 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 20 to 42 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location