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

Phase 2

Completed

• Conditions: Uterine Leiomyoma
• Interventions: Drug: Dienogest 2 MG; Drug: N-acetyl cysteine

• Registration Number: NCT06115408
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Study First Submitted: 2023-03-09
• Study Start: 2023-09-01
• Study First Submitted QC: 2023-10-29
• Study First Posted: 2023-11-03
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug;Dienogest	Dienogest 2 MG	2mg pills oral daily
Drug;N-Acetylcysteine	N-acetyl cysteine	600 mg/day oral daily

Primary Outcome Measures

Name	Time	Method
leiomyoma size reduction	3 months	vertical x horizontal diameter in mm by transvaginal U/S

Secondary Outcome Measures

Name	Time	Method
blood loss	3 months	by hemoglobin level
Dysmenorrhea	3 Monthes	according to the visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)
heavy menstrual bleeding	3 months	assess by PBAC score

Trial Locations

Locations (1)

Ainshams University; 🇪🇬 Cairo, Egypt