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

Uterine Leiomyoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06115408
• Other study ID #: Leiomyoma volume reduction
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Ain Shams University
• Contact: Esraa Awd
• Phone: +201019000586
• Email: Awade0343[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Leiomyoma

Intervention

Drug:
• Dienogest 2 MG
Clinical trial
• N-acetyl cysteine
Clinical trial

Locations

Country	Name	City	State
Egypt	Ainshams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leiomyoma volume change	Measure leiomyoma volume change in 3 dimensions in cm	3 Monthes
Secondary	Dysmenorrhea	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
Secondary	Heavy menstrual bleeding	assess any abnormal uterine bleeding (AUB) by FIGO System is according to frequency, duration, regularity and flow volume.	3months