EndometriomaendometriomaNCT07770594
Effect of Dienogest in Symptomatic Endometrioma in Comparison to Combined Oral Contraceptive Pill.
A study testing Tab.Dienogest 2 mg 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. Dienogest 2mg 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.Dienogest 2 mg 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
None listed.
Who cannot join
- -
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. Dienogest 2mg 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.Dienogest (Tab.Dienogest of Nuvista pharmaceuticals) 2mg 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.Dienogest 2 mg, Combined oral contraceptive pill (ethinyl estradiol,30mcg+desogestrel,150mcg) tablet
- Keywords
- symptomatic endometrioma ,VAS,Size of OMA
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tab.Dienogest 2 mgDrug
Tab 2mg 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) tabletDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Tab.Dienogest 2 mg | Experimental | Tab.Dienogest 2mg 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.Dienogest 2 mg |
| 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.
2. Change in Pain score (measured inVAS)
Description: 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
Measured: 3 months
1. Change in size of endometrioma(mean diameter)assessed by transvaginal ultrasound.
Description: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 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
- NCT07770594
- Sponsor's protocol ID
- 5482
- Acronym
- endometrioma
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piacenti I, Viscardi MF, Masciullo L, Sangiuliano C, Scaramuzzino S, Piccioni MG, Muzii L, Benedetti Panici P, Porpora MG. Dienogest versus continuous oral levonorgestrel/EE in patients with endometriosis: what's the best choice? Gynecol Endocrinol. 2021 May;37(5):471-475. doi: 10.1080/09513590.2021.1892632. Epub 2021 Mar 2.
PubMed 33650928El Taha L, Abu Musa A, Khalifeh D, Khalil A, Abbasi S, Nassif J. Efficacy of dienogest vs combined oral contraceptive on pain associated with endometriosis: Randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2021 Dec;267:205-212. doi: 10.1016/j.ejogrb.2021.10.029. Epub 2021 Oct 30.
PubMed 34826668
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dienogest in Symptomatic Endometrioma in Comparison to Combined Oral Contraceptive Pill.
- ClinicalTrials.gov ID
- NCT07770594
- Acronym / sponsor ID
- endometrioma / 5482
- Conditions
- Endometrioma
- Keywords
- symptomatic endometrioma ,VAS,Size of OMA
- 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
- 18 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. Dienogest 2mg 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.Dienogest (Tab.Dienogest of Nuvista pharmaceuticals) 2mg 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.Dienogest 2 mg | Experimental | Drug: Tab.Dienogest 2 mgTab.Dienogest 2mg 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 (0 listed)
Key exclusion criteria (1 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.Dienogest 2 mgTab 2mg 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.Dienogest 2 mg |
| 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 | Drug | Combined oral contraceptive pill (ethinyl estradiol,30mcg+desogestrel,150mcg) tablet |
Primary outcome
2. Change in Pain score (measured inVAS)
Time frame: 3 months
Description: 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
1. Change in size of endometrioma(mean diameter)assessed by transvaginal ultrasound.
Time frame: 3 months
Description: 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
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 18 Aug 2026.
- Results publication: PubMed 33650928Piacenti I, Viscardi MF, Masciullo L, Sangiuliano C, Scaramuzzino S, Piccioni MG, Muzii L, Benedetti Panici P, Porpora MG. Dienogest versus continuous oral levonorgestrel/EE in patients with endometriosis: what's the best choice? Gynecol Endocrinol. 2021 May;37(5):471-475. doi: 10.1080/09513590.2021.1892632. Epub 2021 Mar 2.
- Results publication: PubMed 34826668El Taha L, Abu Musa A, Khalifeh D, Khalil A, Abbasi S, Nassif J. Efficacy of dienogest vs combined oral contraceptive on pain associated with endometriosis: Randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2021 Dec;267:205-212. doi: 10.1016/j.ejogrb.2021.10.029. Epub 2021 Oct 30.
- Individual participant dataSharing planned: No
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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.Dienogest 2 mg 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 0 inclusion and 1 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 18 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?
2. Change in Pain score (measured inVAS) (time frame: 3 months). 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 NCT07770594, 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 18 Aug 2026.