Clinical trial · Interventional
Evaluation of Using Dienogest and N-Acetyl Cysteine on the Volume of Uterine Leiomyoma
NCT06115408CI-TRIAL-00083780completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This 2 arm randomized clinical trial will assess the impact of Dienogest and N-Acetyl Cysteine on volume reduction of uterine leiomyoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Leiomyoma | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dienogest 2 MG | Drug | — | UNRESOLVED |
| N-acetyl cysteine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Drug;Dienogest
- description
- 2mg pills oral daily
- interventionNames
- Drug: Dienogest 2 MG
- type
- EXPERIMENTAL
- label
- Drug;N-Acetylcysteine
- description
- 600 mg/day oral daily
- interventionNames
- Drug: N-acetyl cysteine
Primary outcomes (1)
- measure
- leiomyoma size reduction
- timeFrame
- 3 months
- description
- vertical x horizontal diameter in mm by transvaginal U/S
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.