EndometriomaendometriomaNCT07763847
Effect of Elagolix in Symptomatic Endometrioma in Comparison to Combined Oral Contraceptive Pill.
A study testing tab Elagolix 150mg and Combined oral contraceptive pill (ethinyl estradiol,30mcg+desogestrel,150mcg) tablet in people with Endometrioma, run by Mst.Sumyara Khatun at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometrioma
- What is being tested?
- tab Elagolix 150mg and Combined oral contraceptive pill (ethinyl estradiol,30mcg+desogestrel,150mcg) tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBangladesh
- Study dates
- 17 Apr 2025to 16 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- 2. 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.
- 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.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
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.
- Conditions
- Endometrioma
- Being tested
- tab Elagolix 150mg, Combined oral contraceptive pill (ethinyl estradiol,30mcg+desogestrel,150mcg) tablet
- Keywords
- symptomatic endometrioma, VAS & size
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tab Elagolix 150mgDrug
orally once daily for 3months
Combined oral contraceptive pill (ethinyl estradiol,30mcg+desogestrel,150mcg) tabletDrug
once daily for 3months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Combined oral contraceptive pill (ethinyl estradiol,30mcg+desogestrel,150mcg) tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start17 Apr 2025
- Primary completion16 Apr 2026
- Study completion16 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EndometriomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open label parallel design randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mst.Sumyara Khatun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mst.Sumyara Khatun, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763847
- Sponsor's protocol ID
- 5481
- Acronym
- endometrioma
- Status last verified
- Apr 2025
- First submitted
- 9 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31654294Taylor 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.
PubMed 28525302
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Elagolix in Symptomatic Endometrioma in Comparison to Combined Oral Contraceptive Pill.
- ClinicalTrials.gov ID
- NCT07763847
- Acronym / sponsor ID
- endometrioma / 5481
- Conditions
- Endometrioma
- Keywords
- symptomatic endometrioma, VAS & size
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mst.Sumyara KhatunUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 16 Apr 2026 (actual)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label parallel design randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| tab elagolix 150mg | Experimental | Drug: tab Elagolix 150mgtab 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 |
| Combined oral contraceptive pill (ethinyl estradiol,30mcg+desogestrel,150mcg) tablet | Active comparator | Drug: Combined oral contraceptive pill (ethinyl estradiol,30mcg+desogestrel,150mcg) tabletCombined 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
- 2. 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.
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tab Elagolix 150mgorally once daily for 3months | Drug | tab elagolix 150mg |
| Combined oral contraceptive pill (ethinyl estradiol,30mcg+desogestrel,150mcg) tabletonce daily for 3months | Drug | Combined oral contraceptive pill (ethinyl estradiol,30mcg+desogestrel,150mcg) tablet |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Results publication: PubMed 31654294Surrey 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.
- Results publication: PubMed 28525302Taylor 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.
- Individual participant dataSharing planned: No
Related trials for Endometrioma
RecruitingPhase 4
Estetrol/Drospirenone to Reduce the Average Size of Endometriomas
Ovarian Endometrioma, Endometrioma
Recruiting
Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometriosis
Endometrioma, Ultrasound Therapy; Complications
Recruiting
Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy
Endometriosis
RecruitingObservational study
Study on the Ultrasound and Biological Characteristics of Atypical Endometriosis.
Endometriosis
Not yet recruitingObservational study
Laparoscopic Sclerotherapy for the Management of Ovarian Endometriomas
Endometriosis, Endometrioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tab Elagolix 150mg and Combined oral contraceptive pill (ethinyl estradiol,30mcg+desogestrel,150mcg) tablet in people with Endometrioma, run by Mst.Sumyara Khatun at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in size of endometrioma(mean diameter)assessed by transvaginal ultrasound. (time frame: 3months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07763847, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.