Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo

Phase 2

Completed

• Conditions: Endometrioma
• Interventions: Drug: Desogestrel Oral Tablet

• Registration Number: NCT04941833
• Lead Sponsor: Rajavithi Hospital

Brief Summary

Use of the oral desogestrel compared with placebo for preoperative treatment of endometrioma in the patient who underwent to surgery in next 3 months The result will be evaluated on cyst diameter, the associated pain and side effect of the oral desogestrel.

Detailed Description

Use of the oral desogestrel compared with placebo for preoperative treatment of endometrioma in the patient who underwent to surgery in next 3 months in Rajvithi hospital Patient will randomized in 2 group : Desogestrel and placebo After 1 months and 3 months the patient have to come to hospital to evaluate the result of study The result will be evaluated on cyst diameter, the associated pain and side effect of the oral desogestrel.

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-06-18
• Study First Posted: 2021-06-28
• Primary Completion: 2022-07-31
• Study Completion: 2022-09-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-27
• Last Update Posted: 2022-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Thai female and foreigner who can understand Thai language
• Age 15-49 years
• Diagnose as endometrioma sized more than 3 cm
• Underwent to surgery in next 13 weeks

Exclusion Criteria

• History of endometriosis
• Pregnancy woman
• Contraindication for desogestrel : History of thrombotic event, Autoimmune disease,gestational trophoblastic disease
• Ovarian endometrioma with complications : Ruptured, twisted
• Contraindications for NSAIDs : Peptic ulcer, thrombocytopenia, liver disease
• History of hormonal treatment for endometrioma : DMPA,OCP, GNRH agonist/antoginist

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Desogestrel group	Desogestrel Oral Tablet	Desogestrel group
Control group	Desogestrel Oral Tablet	Placebo

Primary Outcome Measures

Name	Time	Method
Cyst diameter	3 months after drug given	Cyst diameter is calculated by transvaginal ultrasound with calculated in the diameter of endometrimas (cm)

Secondary Outcome Measures

Name	Time	Method
Associated pain	3 months after drug given	Associated pain is measured by the visual analog score. The patients will record the score on the book everytimes when they have pain

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand