AdenomyosisPhase 1NCT06719934
Ttt of Adenomyosis
A Phase 1 study testing Dienogest 2 mg orally and UAE in people with Adenomyosis, run by Al-Azhar University at 1 site in Egypt.
Trial summary
to evaluate use of Dienogest versus uterine arteries embolization in treatment of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Adenomyosis
- What is being tested?
- Dienogest 2 mg orally and UAE
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Jan 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with adenomyosis
- With or without small fibroids
- Suffering from heavy menstrual bleeding, dysmenorrhea, and/or cycle- independent pain and bulk-related symptoms.
Who cannot join
- - Presence of a malignancy or pelvic infection.
- An on-going pregnancy or a desire to conceive in the future.
- Absolute contraindication for angiography (renal impairment).
- Chronic debilitating diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Al Azhar university
Asyut, Assuit, 71524
Gamal mohammed Abd El Moez, 201006704553+, azhararabi46@yahoo.com
About this study
Official title: Dienogest Versus Uterine Artery Embolization in Ttt of Adenomyosis -cohort Comparetive Study
to evaluate use of Dienogest versus uterine arteries embolization in treatment of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms
Read the detailed description
Type of the study: prospective cohort comparative study. Setting: It will be done at both Obstetrics \& Gynecology department and Radiology department, Al-Azhar University Hospital Assiut branch.
Time of the study: Starting from January 2025 till the end of the study Number of cases: 100 cases. According to sample size equation Where; in: n = number of patients, = 1.96 (standard normal deviate value that divides the central 95% of z distribution from 5% in the tails), P = the reported sensitivity (67%, i.e., 0.67), L= absolute precision desired on either side (half width of the confidence interval of the confidence interval) of sensitivity (10% i.e., 0.1).
Inclusion criteria:
- Age Group: 30-50 years
- Women with adenomyosis
- With or without small fibroids
- Suffering from heavy menstrual bleeding, dysmenorrhea, and/or cycle- independent pain and bulk-related symptoms.
Exclusion criteria:
- Presence of a malignancy or pelvic infection.
- An on-going pregnancy or a desire to conceive in the future.
- Absolute contraindication for angiography (renal impairment).
- Chronic debilitating diseases.
- Conditions
- Adenomyosis
- Being tested
- Dienogest 2 mg orally, UAE
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dienogest 2 mg orallyDrug
2 mg Dienogest orally
UAEProcedure or surgery
under local anasthesia uterine artery embolizationwill be done
| Study group | Role | What they receive |
|---|---|---|
| Dienogest group | Experimental | will take 2 mg oral Dienogest Receives: Drug: Dienogest 2 mg orally |
| Uterine artery embolization | Experimental | will undergoes uterine artery embolization by local anasthesia Receives: Procedure: UAE |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation use of Dienogest versus uterine arteries embolization in treatment of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms by questionnaire
evaluation use of Dienogest versus uterine arteries embolization in improvement of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms by questionnaire
Measured: through study completion ,an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eshraq Arabi, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719934
- Sponsor's protocol ID
- 121212121212121212121212121212
- Status last verified
- Nov 2024
- First submitted
- 27 Nov 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dienogest Versus Uterine Artery Embolization in Ttt of Adenomyosis -cohort Comparetive Study
- ClinicalTrials.gov ID
- NCT06719934
- Acronym / sponsor ID
- 121212121212121212121212121212
- Conditions
- Adenomyosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 6 Dec 2024 (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.
to evaluate use of Dienogest versus uterine arteries embolization in treatment of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms
Detailed description
Type of the study: prospective cohort comparative study. Setting: It will be done at both Obstetrics \& Gynecology department and Radiology department, Al-Azhar University Hospital Assiut branch.
Time of the study: Starting from January 2025 till the end of the study Number of cases: 100 cases. According to sample size equation Where; in: n = number of patients, = 1.96 (standard normal deviate value that divides the central 95% of z distribution from 5% in the tails), P = the reported sensitivity (67%, i.e., 0.67), L= absolute precision desired on either side (half width of the confidence interval of the confidence interval) of sensitivity (10% i.e., 0.1).
Inclusion criteria:
- Age Group: 30-50 years
- Women with adenomyosis
- With or without small fibroids
- Suffering from heavy menstrual bleeding, dysmenorrhea, and/or cycle- independent pain and bulk-related symptoms.
Exclusion criteria:
- Presence of a malignancy or pelvic infection.
- An on-going pregnancy or a desire to conceive in the future.
- Absolute contraindication for angiography (renal impairment).
- Chronic debilitating diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dienogest group | Experimental | Drug: Dienogest 2 mg orallywill take 2 mg oral Dienogest |
| Uterine artery embolization | Experimental | Procedure: UAEwill undergoes uterine artery embolization by local anasthesia |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women with adenomyosis
- With or without small fibroids
- Suffering from heavy menstrual bleeding, dysmenorrhea, and/or cycle- independent pain and bulk-related symptoms.
Key exclusion criteria (4 listed)
- - Presence of a malignancy or pelvic infection.
- An on-going pregnancy or a desire to conceive in the future.
- Absolute contraindication for angiography (renal impairment).
- Chronic debilitating diseases.
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 mg orally2 mg Dienogest orally | Drug | Dienogest group |
| UAEunder local anasthesia uterine artery embolizationwill be done | Procedure or surgery | Uterine artery embolization |
Primary outcome
evaluation use of Dienogest versus uterine arteries embolization in treatment of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms by questionnaire
Time frame: through study completion ,an average of 1 year
evaluation use of Dienogest versus uterine arteries embolization in improvement of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms by questionnaire
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dienogest 2 mg orally and UAE in people with Adenomyosis, run by Al-Azhar 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 4 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: opening soon, as of the sponsor's last update on 6 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AL-Azhar university Assuit (0882148087, Eshrq.arabi2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation use of Dienogest versus uterine arteries embolization in treatment of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms by questionnaire (time frame: through study completion ,an average of 1 year). 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 6 Dec 2024.