Uterine LeiomyomaPhase 2/3NCT06115408
Evaluation of Using Dienogest and N-Acetyl Cysteine on the Volume of Uterine Leiomyoma
A Phase 2/3 study testing Dienogest 2 MG and N-acetyl cysteine in people with Uterine Leiomyoma, run by Ain Shams University at 1 site in Egypt.
Trial summary
This 2 arm randomized clinical trial will assess the impact of Dienogest and N-Acetyl Cysteine on volume reduction of uterine leiomyoma Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Leiomyoma
- What is being tested?
- Dienogest 2 MG and N-acetyl cysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 31 Aug 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 20-45 years.
- 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.
- Regular menstruation: regular period interval from 21 to 35 days.
Who cannot join
- Pregnant or menopausal women.
- History of malignancies, metabolic, hematologic, cardiac, thromboembolism, diabetes, renal or hepatic diseases.
- History of hormonal drug use or treatment for leiomyoma in the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
This 2 arm randomized clinical trial will assess the impact of Dienogest and N-Acetyl Cysteine on volume reduction of uterine leiomyoma
Read the 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
- Conditions
- Uterine Leiomyoma
- Being tested
- Dienogest 2 MG, N-acetyl cysteine
- Keywords
- Fibroids dienogest NAC
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dienogest 2 MGDrug
Also called Gynoprogest
Clinical trial
N-acetyl cysteineDrug
Also called Gemacysteine
Clinical trial
| Study group | Role | What they receive |
|---|---|---|
| Drug;Dienogest | Experimental | 2mg pills oral daily Receives: Drug: Dienogest 2 MG |
| Drug;N-Acetylcysteine | Experimental | 600 mg/day oral daily Receives: Drug: N-acetyl cysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
leiomyoma size reduction
vertical x horizontal diameter in mm by transvaginal U/S
Measured: 3 months
Secondary outcomes (3)
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)
Measured: 3 Monthes
heavy menstrual bleeding
assess by PBAC score
Measured: 3 months
blood loss
by hemoglobin level
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Sep 2023
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine LeiomyomaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be conducted on 40 women; they will be subdivided into 2equal groups .each group receive different intervention
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mosaad Awd El-sayed, Ain Shams University
- Investigators
- Amr Mahmoud, lecturer, Study chair, Ain Shams UniversityAhmed mohamed mamdouh, assisstant professor, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115408
- Sponsor's protocol ID
- Leiomyoma volume reduction
- Status last verified
- Dec 2024
- First submitted
- 9 Mar 2023
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of individual participant data collecting during the trial ,after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Using Dienogest and N-Acetyl Cysteine on the Volume of Uterine Leiomyoma
- ClinicalTrials.gov ID
- NCT06115408
- Acronym / sponsor ID
- Leiomyoma volume reduction
- Conditions
- Uterine Leiomyoma
- Keywords
- Fibroids dienogest NAC
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- The study will be conducted on 40 women; they will be subdivided into 2equal groups .each group receive different intervention
| Arm | Type | Receives |
|---|---|---|
| Drug;Dienogest | Experimental | Drug: Dienogest 2 MG2mg pills oral daily |
| Drug;N-Acetylcysteine | Experimental | Drug: N-acetyl cysteine600 mg/day oral daily |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 20-45 years.
- 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.
- Regular menstruation: regular period interval from 21 to 35 days.
Key exclusion criteria (3 listed)
- Pregnant or menopausal women.
- History of malignancies, metabolic, hematologic, cardiac, thromboembolism, diabetes, renal or hepatic diseases.
- History of hormonal drug use or treatment for leiomyoma in the past 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dienogest 2 MGAlso: GynoprogestClinical trial | Drug | Drug;Dienogest |
| N-acetyl cysteineAlso: GemacysteineClinical trial | Drug | Drug;N-Acetylcysteine |
Primary outcome
leiomyoma size reduction
Time frame: 3 months
vertical x horizontal diameter in mm by transvaginal U/S
3 secondary outcomes
Dysmenorrhea
Time frame: 3 Monthes
heavy menstrual bleeding
Time frame: 3 months
blood loss
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: Yes. All of individual participant data collecting during the trial ,after deidentification
Related trials for Uterine Leiomyoma
Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr Mahmoud, lecturer study chair
Ain Shams University
Ahmed mohamed mamdouh, assisstant professor study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dienogest 2 MG and N-acetyl cysteine in people with Uterine Leiomyoma, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
leiomyoma size reduction (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.