Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-09-30

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.

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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.

Conditions

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Endometrioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Desogestrel group

Group Type EXPERIMENTAL

Desogestrel Oral Tablet

Intervention Type DRUG

Cerazette is the brand name of the desogestrel which contain of 0.075 mg of desogestrel

Control group

Placebo

Group Type PLACEBO_COMPARATOR

Desogestrel Oral Tablet

Intervention Type DRUG

Cerazette is the brand name of the desogestrel which contain of 0.075 mg of desogestrel

Interventions

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Desogestrel Oral Tablet

Cerazette is the brand name of the desogestrel which contain of 0.075 mg of desogestrel

Intervention Type DRUG

Other Intervention Names

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Cerazette

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

Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes