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Postoperative Desogestrel for Endometriosis Related Pain

Primary Purpose

Endometriosis

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Desogestrel
Placebo
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis, Desogestrel, Placebo

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of medicine Siriraj hospital, Mahidol university
  • Siriraj hospital Mahidol university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Desogestrel

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Side effect compared between both group
Patients satisfaction compare between both groups

Full Information

First Posted
March 12, 2012
Last Updated
April 8, 2015
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01559480
Brief Title
Postoperative Desogestrel for Endometriosis Related Pain
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis, Desogestrel, Placebo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desogestrel
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Desogestrel
Other Intervention Name(s)
Cerazette
Intervention Description
Desogestrel 75 mcg Takes 1 capsule before bedtime for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule takes 1 capsule before bedtime for 6 months
Primary Outcome Measure Information:
Title
Pain score
Description
Pain score will be assessed by visual analog scale (0-10)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Side effect compared between both group
Time Frame
6 month
Title
Patients satisfaction compare between both groups
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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 Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prasong Tanmahasamut, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine Siriraj hospital, Mahidol university
City
Bangkok noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Siriraj hospital Mahidol university
City
Bangkok noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

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Postoperative Desogestrel for Endometriosis Related Pain

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