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

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Uterine Leiomyoma

Treatments: Drug: Dienogest 2 MG; Drug: N-acetyl cysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT06115408

Leiomyoma volume reduction

Details and patient eligibility

About

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

Full 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

Enrollment: 40 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Drug;Dienogest

Experimental group

Description:

2mg pills oral daily

Treatment:

Drug: Dienogest 2 MG

Drug;N-Acetylcysteine

Experimental group

Description:

600 mg/day oral daily

Treatment:

Drug: N-acetyl cysteine