Postoperative Desogestrel for Endometriosis Related Pain

Not Applicable

Completed

• Conditions: Endometriosis
• Interventions: Drug: Placebo; Drug: Desogestrel

• Registration Number: NCT01559480
• Lead Sponsor: Mahidol University

Brief Summary

Endometriosis is one of the most common disease in reproductive aged women.Surgical intervention has a significant symptoms relief. However, symptom recurrence is often after surgery. This study aims to determine the efficacy of Desogestrel compared with placebo in pain symptom of symptomatic endometriosis patient undergo conservative surgery . The primary outcome measurement is pain score at 6 months after surgery.

Detailed Description

After conservative surgery, the patients are randomized to Desogestrel and placebo groups. VAS pain score are compared after complete 6 months

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-12
• Study First Submitted QC: 2012-03-20
• Study First Posted: 2012-03-21
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• diagnoses endometriosis
• Plan conservative surgery
• initial pain score at least 5
• voluntary to be the participant of this study with inform consent
• No desired child bearing in 6 months

Exclusion Criteria

• residual lesion after surgery which required further treatment
• cannot participate complete 6 months after surgery
• contraindication for Desogestrel, Paracetamol or Ponstan
• Pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Desogestrel	Desogestrel	-

Primary Outcome Measures

Name	Time	Method
Pain score	6 months	Pain score will be assessed by visual analog scale (0-10)

Secondary Outcome Measures

Name	Time	Method
Side effect compared between both group	6 month
Patients satisfaction compare between both groups	6 months

Trial Locations

Locations (2)

Faculty of medicine Siriraj hospital, Mahidol university; 🇹🇭 Bangkok noi, Bangkok, Thailand

Siriraj hospital Mahidol university; 🇹🇭 Bangkok noi, Bangkok, Thailand