Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 4:27 AM
Study NCT ID:
NCT06719934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-06
First Post:
2024-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ttt of Adenomyosis
Sponsor:
Al-Azhar University
Organization:
Study Overview
Official Title:
Dienogest Versus Uterine Artery Embolization in Ttt of Adenomyosis -cohort Comparetive Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: