Ttt of Adenomyosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dienogest 2 mg orally, UAE.
- Who it may be relevant to
- Registry conditions: Adenomyosis. Basic parameters: 30 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dienogest Versus Uterine Artery Embolization in Ttt of Adenomyosis -cohort Comparetive Study
Overview
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.
Interventions
- Drug Dienogest 2 mg orally
2 mg Dienogest orally - Procedure UAE
under local anasthesia uterine artery embolizationwill be done
Primary outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Al Azhar university — Asyut
Identifiers
NCT: NCT06719934 · 121212121212121212121212121212