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Completed

NCT Number: NCT06115408

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

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

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Key information

Conditions

Uterine Leiomyoma Connective Tissue Diseases Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Skin and Connective Tissue Diseases

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ainshams University

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Dienogest 2 MG

Drug

Clinical trial

Other names: Gynoprogest

N-acetyl cysteine

Drug

Clinical trial

Other names: Gemacysteine

Primary outcomes

  1. leiomyoma size reduction

    Time frame: 3 months

    vertical x horizontal diameter in mm by transvaginal U/S

Secondary outcomes

  1. Dysmenorrhea

    Time frame: 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)

  2. heavy menstrual bleeding

    Time frame: 3 months

    assess by PBAC score

  3. blood loss

    Time frame: 3 months

    by hemoglobin level

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 3, 2023
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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