An interventional study of tab Elagolix 150mg and Combined oral contraceptive pill (ethinyl estradiol,30mcg+desogestrel,150mcg) tablet in Endometrioma, sponsored by Mst.Sumyara Khatun. Completed at 1 site in Bangladesh. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Mst.Sumyara Khatun · Not applicable, Interventional, and Treatment
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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
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.
921 studies on the registry are indexed under Endometriosis; 267 are open to participants now.
This study's enrollment of 60 is below the median of 67 across 541 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Mst.Sumyara Khatun is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:1. Any to Elagolix such as osteoporosis, severe hepatic impairment, to elagolix.
2. Any contraindications toCombined Oral Pillsuch as thromboembolic disorder, active liver disease,H/o cerebrovascular or coronary disease, migrane, undiagnosed vaginal bleeding, hypersensitivity to COCP.
3. Uncontrolled medical disease(Renal disease, HTN, DM). 4. Patients with history of any other hormonal treatment for suppression of endometrioma in last3months.
5. Known case of psychiatric disturbance.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
tab elagolix 150mg orally once daily for 3months.Size of endometrioma (mean diameter) by transvaginal sonography and pain score by VAS will be recorded at the end of 3rd month of therapy
Drug: tab Elagolix 150mg
Combined oral contraceptive pill (ethinyl estradiol,30mcg+desogestrel,150mcg) tablet once daily orally for three months without 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
Drug: Combined oral contraceptive pill (ethinyl estradiol,30mcg+desogestrel,150mcg) tablet
orally once daily for 3months
Drug page: Ethinyl Estradiol
once daily for 3months
Change in size of endometrioma(mean diameter)assessed by transvaginal ultrasound.
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
Change in Pain score (measured inVAS)
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.
Time frame: 3months
Plan to share: No
Ran from Apr 2025 to primary completion in Apr 2026, 11 months.
Of 198 non-industry interventional studies with no phase under Endometriosis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 44. This study's 11 months is below that.
Counting every sponsor, half of 213 studies reached it within 25 months; a quarter within 13 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Mst.Sumyara Khatun