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

Last updated: December 13, 2024
Sponsor: Ain Shams University
Overall Status: Completed

Phase

2/3

Condition

Sarcoma (Pediatric)

Desmoid Tumors

Uterine Disorders

Treatment

Dienogest 2 MG

N-acetyl cysteine

Clinical Study ID

NCT06115408
Leiomyoma volume reduction
  • Ages 20-45
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age: 20-45 years.

  2. Women with uterine leiomyoma (sub-mucous, sub-serous or intramural) based ontransvaginal sonography criteria. Uterine fibroids most often appear as concentric,solid, hypoechoic masses. This appearance results from the prevailing muscle, whichis observed at histologic examination. These solid masses absorb sound waves andtherefore cause a variable amount of acoustic shadowing.

  3. Regular menstruation: regular period interval from 21 to 35 days.

Exclusion

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

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Dienogest 2 MG
Phase: 2/3
Study Start date:
September 01, 2023
Estimated Completion Date:
August 31, 2024

Study 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

Connect with a study center

  • Ainshams University

    Cairo,
    Egypt

    Site Not Available

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