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OpenTrials
Completed

NCT Number: NCT07763847

Effect of Elagolix in Symptomatic Endometrioma in Comparison to Combined Oral Contraceptive Pill.

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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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bangladesh Medical University

Dhaka, Shahbag, 1000, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Diagnosed case of symptomatic endometrioma by transvaginal ultrasound Mean diameter 2-5 cm. Patient present with moderate & severe dysmenorrhea. 2.Age 18-40 years

Exclusion criteria

1. Any contraindications to Elagolix such as osteoporosis, severe hepatic impairment, hypersensitivity to elagolix.

  • Any contraindications toCombined Oral Contraceptive Pillsuch as thromboembolic disorder, active liver disease,H/o cerebrovascular or coronary disease, migrane, undiagnosed vaginal bleeding, hypersensitivity to COCP.
  • Uncontrolled medical disease(Renal disease, HTN, DM). 4. Patients with history of any other hormonal treatment for suppression of endometrioma in last3months.
  • Known case of psychiatric disturbance.

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Treatment and study plan

tab Elagolix 150mg

Drug

orally once daily for 3months

Combined oral contraceptive pill (ethinyl estradiol,30mcg+desogestrel,150mcg) tablet

Drug

once daily for 3months

Primary outcomes

  1. Change in size of endometrioma(mean diameter)assessed by transvaginal ultrasound.

    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.

  2. Change in Pain score (measured inVAS)

    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.

Sponsors and collaborators

Lead sponsor

Mst.Sumyara Khatun

Other

Registry information

Acronym: endometrioma

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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