Evaluation of Using Dienogest and N-Acetyl Cysteine on the Volume of Uterine Leiomyoma

Leiomyoma volume reduction

This 2 arm randomized clinical trial will assess the impact of Dienogest and N-Acetyl Cysteine on volume reduction of uterine leiomyoma

2023-07-01

2023-10-31

2023-12-31

Recruiting

Early phase I

40

Inclusion Criteria: 1. Age: 20-45 years. 2. 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. 3. Regular menstruation: regular period interval from 21 to 35 days. Exclusion Criteria: 1. Pregnant or menopausal women. 2. History of malignancies, metabolic, hematologic, cardiac, thromboembolism, diabetes, renal or hepatic diseases. 3. History of hormonal drug use or treatment for leiomyoma in the past 3 months.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will be conducted on 40 women; they will be subdivided into 2equal groups .each group receive different intervention', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2023-11-03