Status:
COMPLETED
Evaluation of Using Dienogest and N-Acetyl Cysteine on the Volume of Uterine Leiomyoma
Lead Sponsor:
Ain Shams University
Conditions:
Uterine Leiomyoma
Eligibility:
FEMALE
20-45 years
Phase:
PHASE2
PHASE3
Brief Summary
This 2 arm randomized clinical trial will assess the impact of Dienogest and N-Acetyl Cysteine on volume reduction of uterine leiomyoma
Detailed Description
Group A women will receive Dienogest orally 2mg pills daily for 3 months .20 cases Group B women will receive NAC orally at a dose of 600 mg/day for 3 months ,20 cases
Eligibility Criteria
Inclusion
- Age: 20-45 years.
- Women with uterine leiomyoma (sub-mucous, sub-serous or intramural) based on transvaginal sonography criteria. Uterine fibroids most often appear as concentric, solid, hypoechoic masses. This appearance results from the prevailing muscle, which is observed at histologic examination. These solid masses absorb sound waves and therefore cause a variable amount of acoustic shadowing.
- Regular menstruation: regular period interval from 21 to 35 days.
Exclusion
- Pregnant or menopausal women.
- History of malignancies, metabolic, hematologic, cardiac, thromboembolism, diabetes, renal or hepatic diseases.
- History of hormonal drug use or treatment for leiomyoma in the past 3 months.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06115408
Start Date
September 1 2023
End Date
August 31 2024
Last Update
December 16 2024
Active Locations (1)
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1
Ainshams University
Cairo, Egypt