Status:
UNKNOWN
Evaluation of the Efficacy and Safety of Drospirenone in the Treatment of Adenomyosis
Lead Sponsor:
University of Palermo
Conditions:
Adenomyosis
Eligibility:
FEMALE
18-60 years
Brief Summary
Adenomyosis is a common benign condition of fertile women and is characterized by dysmenorrhea, hypermenorrhea, abnormal uterine bleeding, infertility and chronic pelvic pain. To date, no clear guide...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06174792
Start Date
December 30 2023
End Date
December 1 2024
Last Update
December 18 2023
Active Locations (1)
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1
Andrea Etrusco
Palermo, Italy, 90123