Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Use of Oral Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo : A Randomized Controlled Trial Evaluation of the Effect on Cyst Diameter and Associated Pain

Conditions
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Endometrioma

Intervention / Treatment
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* Drug: Desogestrel Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desogestrel group<br>Desogestrel group | Drug: Desogestrel Oral Tablet<br>* Cerazette is the brand name of the desogestrel which contain of 0.075 mg of desogestrel<br>* Other names: Cerazette;|
| Placebo Comparator: Control group<br>Placebo | Drug: Desogestrel Oral Tablet<br>* Cerazette is the brand name of the desogestrel which contain of 0.075 mg of desogestrel<br>* Other names: Cerazette;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cyst diameter | Cyst diameter is calculated by transvaginal ultrasound with calculated in the diameter of endometrimas (cm) | 3 months after drug given | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associated pain | Associated pain is measured by the visual analog score. The patients will record the score on the book everytimes when they have pain | 3 months after drug given |