Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
100 participants
INTERVENTIONAL
2025-01-01
2026-01-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Dienogest group
will take 2 mg oral Dienogest
Dienogest 2 mg orally
2 mg Dienogest orally
Uterine artery embolization
will undergoes uterine artery embolization by local anasthesia
UAE
under local anasthesia uterine artery embolizationwill be done
Interventions
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Dienogest 2 mg orally
2 mg Dienogest orally
UAE
under local anasthesia uterine artery embolizationwill be done
Eligibility Criteria
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Inclusion Criteria
* With or without small fibroids
* Suffering from heavy menstrual bleeding, dysmenorrhea, and/or cycle- independent pain and bulk-related symptoms.
Exclusion Criteria
* An on-going pregnancy or a desire to conceive in the future.
* Absolute contraindication for angiography (renal impairment).
* Chronic debilitating diseases.
30 Years
50 Years
FEMALE
No
Sponsors
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Al-Azhar University
OTHER
Responsible Party
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Eshraq Arabi
Assuit
Locations
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Al Azhar university
Asyut, Assuit, Egypt
Countries
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Central Contacts
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Facility Contacts
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Gamal mohammed Abd El Moez
Role: primary
Other Identifiers
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121212121212121212121212121212
Identifier Type: -
Identifier Source: org_study_id