Status:
COMPLETED
UA Versus UAE in Treatment of Fibroids
Lead Sponsor:
Ain Shams Maternity Hospital
Conditions:
Uterine Fibroid
Eligibility:
All Genders
35-50 years
Phase:
PHASE4
Brief Summary
Study objective: To prove that Ulipristal acetate is an effective line of management for uterine fibroids by causing a significant decline in fibroid volumes resulting in a substantial relief of fibro...
Detailed Description
Inclusion Criteria: Women with symptomatic uterine fibroids were recruited into the study after fulfilling the following criteria: * Their age should range from 35 to 50 years. * Their body mass ind...
Eligibility Criteria
Inclusion
- Their age should range from 35 to 50 years.
- Their body mass index (BMI) should range from 18 to 35 Kg/m2.
- The presence of one or more symptomatic type 2, 3, 4, 5, or 6 uterine fibroids according to the FIGO classification.
- The dominant fibroid diameter should range from 4 to 8 cm as assessed by ultrasound.
- They should not be seeking future fertility.
- They should be refusing any surgical intervention whether myomectomy or hysterectomy.
Exclusion
- Post-menopausal status or premature ovarian failure.
- Type 0, 1 and 7 uterine fibroids according to FIGO classification.
- Previous myomectomy or any uterine surgery.
- Previous or ongoing hormonal treatment.
Key Trial Info
Start Date :
March 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04832906
Start Date
March 13 2019
End Date
March 13 2021
Last Update
April 6 2021
Active Locations (1)
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1
Ain Shams Maternity Hospital
Cairo, Abbassia, Egypt, 11517