Evaluation of the Efficacy and Safety of Drospirenone in the Treatment of Adenomyosis

Launched by UNIVERSITY OF PALERMO · Dec 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called drospirenone to treat adenomyosis, a condition that affects many women and causes symptoms like painful periods, heavy bleeding, and pelvic pain. The goal of the study is to see how well drospirenone works to relieve these symptoms and improve the quality of life for women with adenomyosis. Currently, there are no specific treatment guidelines for adenomyosis, so this trial aims to fill that gap by testing a progestin, which is a type of hormone that may help manage the condition.

To participate in this trial, women must be at least 18 years old, have regular menstrual cycles, and have been diagnosed with adenomyosis through imaging tests like MRI or ultrasound. They should also be experiencing significant pain during their menstrual cycle. However, women with other related conditions like endometriosis or severe anemia will not be eligible to join. Participants will receive drospirenone and will be monitored for its effects on their symptoms and overall well-being. This is an important trial because it could lead to new treatment options for women suffering from adenomyosis.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • age 18 years or older;
• • regular menstrual cycle;
• • adenomyosis diagnosed by imaging analysis (magnetic resonance imaging \[MRI\] or transvaginal ultrasound);
• • no other treatment for adenomyosis for at least 3 months before drospirenone administration;
• • painful symptoms (lower abdominal and/or lower back pain) with a score of three points or more on the verbal pain rating scale developed by Harada et al. during the menstrual cycle.
• Exclusion Criteria:
• • endometriosis or uterine leiomyoma diagnosed by imaging analysis (MRI or transvaginal ultrasound);
• • benign ovarian cyst including endometrioma;
• • other endocrine diseases;
• • severe anemia (hemoglobin concentrations \<8.0 g/dL).