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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06115408

Enrollment

Registered

2023-11-03

Start date

2023-09-01

Completion date

2024-08-31

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Leiomyoma

Keywords

Fibroids dienogest NAC

Brief summary

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

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

Interventions

DRUGDienogest 2 MG

Clinical trial

DRUGN-acetyl cysteine

Clinical trial

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Caregiver)

Intervention model description

The study will be conducted on 40 women; they will be subdivided into 2equal groups .each group receive different intervention

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
leiomyoma size reduction	3 months	vertical x horizontal diameter in mm by transvaginal U/S

Secondary

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026