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

October 29, 2023 updated by: Esraa Mosaad Awd El-sayed, Ain Shams University
This 2 arm randomized clinical trial will assess the impact of Dienogest and N-Acetyl Cysteine on volume reduction of uterine leiomyoma

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leiomyoma volume change
Time Frame: 3 Monthes
Measure leiomyoma volume change in 3 dimensions in cm
3 Monthes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 Monthes
Heavy menstrual bleeding
Time Frame: 3months
assess any abnormal uterine bleeding (AUB) by FIGO System is according to frequency, duration, regularity and flow volume.
3months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Amr Mahmoud, ain shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

October 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

October 29, 2023

First Posted (Estimated)

November 3, 2023

Study Record Updates

Last Update Posted (Estimated)

November 3, 2023

Last Update Submitted That Met QC Criteria

October 29, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Leiomyoma volume reduction

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of individual participant data collecting during the trial ,after deidentification

IPD Sharing Time Frame

Immediately following publication.no end date

IPD Sharing Access Criteria

Any purpose

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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