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

NCT07770594 | Completed

• 1 other identifier: 5482
• 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. 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

Conditions

Endometrioma

Keywords

symptomatic endometrioma ,VAS,Size of OMA

Outcome Measures

Primary Outcomes (2)

• 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

  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

  3 months

Study Arms (2)

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

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

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

Interventions

Tab.Dienogest 2 mg DRUG

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

Tab.Dienogest 2 mg

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

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

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.
• usion Criteria:

Sponsors & Collaborators

• Mst.Sumyara Khatun: lead

Study Sites (1)

Bangladesh Medical University

Dhaka, Shahbag, 1000, Bangladesh

Location

Related Publications (2)

• 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.

  PMID: 33650928 RESULT

• El 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.

  PMID: 34826668 RESULT

MeSH Terms

Conditions

Endometriosis

Interventions

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 13, 2026
• First Posted: August 18, 2026
• Study Start: April 17, 2025
• Primary Completion: April 16, 2026
• Study Completion: April 16, 2026
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)