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

Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06115408
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
6
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Dienogest 2 MG
  • Drug: N-acetyl cysteine
 Phase 2/Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study will be conducted on 40 women; they will be subdivided into 2equal groups .each group receive different interventionThe study will be conducted on 40 women; they will be subdivided into 2equal groups .each group receive different intervention
Masking:
Single (Care Provider)
Primary Purpose:
Health Services Research
Official Title:
Evaluation of Using Dienogest and N-Acetyl Cysteine on the Volume of Uterine Leiomyoma
Actual Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Drug;Dienogest

2mg pills oral daily

Drug: Dienogest 2 MG
Clinical trial
Other Names:
  • Gynoprogest

    		•
    Experimental: Drug;N-Acetylcysteine

    600 mg/day oral daily

    Drug: N-acetyl cysteine
    Clinical trial
    Other Names:
  • Gemacysteine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Leiomyoma volume change [3 Monthes]

      Measure leiomyoma volume change in 3 dimensions in cm

    Secondary Outcome Measures

    1. 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)

    2. Heavy menstrual bleeding [3months]

      assess any abnormal uterine bleeding (AUB) by FIGO System is according to frequency, duration, regularity and flow volume.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ainshams University Cairo Egypt

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Study Chair: Amr Mahmoud, Ain Shams University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Esraa Mosaad Awd El-sayed, Researcher,ob/gyn Resident, Principal Investigator, Esraa Awd, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT06115408
    Other Study ID Numbers:
    • Leiomyoma volume reduction
    First Posted:
    Nov 3, 2023
    Last Update Posted:
    Nov 3, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Esraa Mosaad Awd El-sayed, Researcher,ob/gyn Resident, Principal Investigator, Esraa Awd, Ain Shams University
    Fibroids dienogest NAC
    Additional relevant MeSH terms:
    Leiomyoma
    Myofibroma
    Acetylcysteine
    Dienogest
    N-monoacetylcystine

    Study Results

    No Results Posted as of Nov 3, 2023