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

NCT07763847 | Completed

• 1 other identifier: 5481
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometrioma

Keywords

symptomatic endometrioma, VAS & size

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3months

Study Arms (2)

tab elagolix 150mg

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

Interventions

tab Elagolix 150mg DRUG

orally once daily for 3months

tab elagolix 150mg

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

once daily for 3months

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: female,symptomatic endometrioma patient
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Mst.Sumyara Khatun: lead

Study Sites (1)

Bangladesh Medical University

Dhaka, Shahbag, 1000, Bangladesh

Location

Related Publications (2)

• Surrey ES, Soliman AM, Palac HL, Agarwal SK. Impact of Elagolix on Workplace and Household Productivity Among Women with Moderate to Severe Pain Associated with Endometriosis: A Pooled Analysis of Two Phase III Trials. Patient. 2019 Dec;12(6):651-660. doi: 10.1007/s40271-019-00394-7.

  PMID: 31654294 RESULT

• Taylor HS, Giudice LC, Lessey BA, Abrao MS, Kotarski J, Archer DF, Diamond MP, Surrey E, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Rowan JP, Duan WR, Ng J, Schwefel B, Thomas JW, Jain RI, Chwalisz K. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089. Epub 2017 May 19.

  PMID: 28525302 RESULT

MeSH Terms

Conditions

Endometriosis

Interventions

elagolix; Contraceptives, Oral, Combined; Ethinyl Estradiol; Desogestrel; Tablets

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Norpregnenes; Dosage Forms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Officer

Model Details: open label parallel design randomized controlled trial

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 13, 2026
• Study Start: April 17, 2025
• Primary Completion: April 16, 2026
• Study Completion: April 16, 2026
• Last Updated: August 13, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)