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

NCT06115408 — Phase 2 / Phase 3, Completed, 40 participants, Ain Shams University

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Registry	NCT06115408
Status	Completed
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: single, health services research
Enrollment	40 (Actual)
Sponsor	Ain Shams University (Other)
Conditions	Uterine Leiomyoma
Interventions	Dienogest 2 MG, N-acetyl cysteine (Drug)
Dates	start 2023-09-01, primary completion 2024-08-31, completion 2024-08-31, first posted 2023-11-03, last updated 2024-12-16
Locations	1 site in Egypt

-Summary

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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+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

+Arms and interventions

Arm	Type	Interventions	Description
Drug;Dienogest	Experimental	Drug: Dienogest 2 MG	2mg pills oral daily
Drug;N-Acetylcysteine	Experimental	Drug: N-acetyl cysteine	600 mg/day oral daily

Dienogest 2 MG (Drug), also known as Gynoprogest: Clinical trial
N-acetyl cysteine (Drug), also known as Gemacysteine: Clinical trial

+Outcome measures

Primary outcomes

leiomyoma size reduction [3 months]: vertical x horizontal diameter in mm by transvaginal U/S

Secondary outcomes

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)
heavy menstrual bleeding [3 months]: assess by PBAC score
blood loss [3 months]: by hemoglobin level

+Eligibility

Sex: Female, ages: 20 Years to 45 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Ainshams University	Cairo	Egypt

+Study documents

Study Protocol (PDF, 2024-10-31)
Statistical Analysis Plan (PDF, 2024-10-31)
Informed Consent Form (PDF, 2024-10-31)

+Investigators

Amr Mahmoud, lecturer, Study chair, Ain Shams University
Ahmed mohamed mamdouh, assisstant professor, Study chair, Ain Shams University