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Clinical Trials/NCT01559480
NCT01559480
Completed
Not Applicable

A Prospective Double Blind Randomized Controlled Trial to Study the Effectiveness of a Desogestrel for the Treatment of Pelvic Pain or Dysmenorrhea in the Patients Undergone Conservative Surgery for Pelvic Endometriosis

Mahidol University2 sites in 1 country40 target enrollmentJanuary 2012
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ConditionsEndometriosis
InterventionsDesogestrelPlacebo
DrugsDesogestrelPlacebo

Overview

Phase
Not Applicable
Intervention
Desogestrel
Conditions
Endometriosis
Sponsor
Mahidol University
Enrollment
40
Locations
2
Primary Endpoint
Pain score
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
October 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Desogestrel

Intervention: Desogestrel

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Pain score

Time Frame: 6 months

Pain score will be assessed by visual analog scale (0-10)

Secondary Outcomes

  • Side effect compared between both group(6 month)
  • Patients satisfaction compare between both groups(6 months)

Study Sites (2)

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