Bangladesh Medical University
Dhaka, Shahbag, 1000, Bangladesh
NCT Number: NCT07763847
women of 18-40 years with symptomatic endometrioma (moderate to severe dysmenorrhea with endometrioma(2-5cm),will be allocated into 2 groups-Experimental group (group A) and comparatorgroup( group B).Experimental group:Tab.Elagolix 150mg tablet once daily orally for three months.
Comparator group:
Combined oral contraceptive pill ,ethinyl estradiol,30mcg+desogestrel,150mcg tabletonce daily orally for three months without any interruption.. Size of endometrioma (mean diameter) by transvaginal sonography and pain score by VAS will be recorded at the end of 3rd month of therapy
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Notify Me18 year–40 year
Female
Interventional
Not applicable
Dhaka, Shahbag, 1000, Bangladesh
This study will be conducted in the department of Reproductive endocrinology and infertility, Bangabandhu sheikh Mujib medical university (BSMMU), from the day of IRB approval. The study population will be women of 18-40 years with symptomatic endometrioma (moderate to severe dysmenorrhea) attending the outpatient department and sonographically diagnosed with endometrioma(2-5cm), fulfilling the inclusion and exclusion criteria.Assessment of endometrioma size will be performed by transvaginal sonography. The mean of the largest two transverse diameters of each endometrioma will be recorded. All the patients will be evaluated for the presence and intensity of pain, including dysmenorrheaand pain reduction will be recorded by VAS score.Selected patients will be allocated into 2 groups-Experimental group (group A) and comparatorgroup( group B).Total 60 patients will be included in this study. Treatment will be started from the first day of menstruation after the baseline visit and investigation.
Experimental group:
Tab.Elagolix (Tab.Egolix of Acme pharmaceuticals) 150mg tablet once daily orally for three months.
Comparator group:
Combined oral contraceptive pill (Tab Desolon of Renata pharmaceuticals),ethinyl estradiol,30mcg+desogestrel,150mcg tabletonce daily orally for three months without any interruption.
The next visit will be scheduled at the end of the 3rd month. Size of endometrioma (mean diameter) by transvaginal sonography and pain score by VAS will be recorded at the end of 3rd month of therapy.For each and every subject separate data collection sheet will be prepared.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1. Any contraindications to Elagolix such as osteoporosis, severe hepatic impairment, hypersensitivity to elagolix.
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orally once daily for 3months
once daily for 3months
Time frame: 3months
The reduction of size will be measured by the percentage reduction in the mean diameter of endometrioma.About 25%-30% of reduction in the mean diameter will be considered as significant change.
Time frame: 3months
Mean reduction in pain sensation measured by visual Analog scale (VAS). Minimal important difference for improvement on the VAS scale will be considered as a 50% decrease on VAS score.
Mst.Sumyara Khatun
Other
Acronym: endometrioma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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