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Postoperative Desogestrel for Endometriosis Related Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01559480
Recruitment Status : Completed
First Posted : March 21, 2012
Last Update Posted : April 9, 2015
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Desogestrel Drug: Placebo Not Applicable

Detailed Description:
After conservative surgery, the patients are randomized to Desogestrel and placebo groups. VAS pain score are compared after complete 6 months
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
Drug Information available for: Desogestrel

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Desogestrel Drug: Desogestrel
Desogestrel 75 mcg Takes 1 capsule before bedtime for 6 months
Other Name: Cerazette
Placebo Comparator: Placebo Drug: Placebo
Placebo capsule takes 1 capsule before bedtime for 6 months


Outcome Measures
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Primary Outcome Measures :
  1. Pain score [ Time Frame: 6 months ]
    Pain score will be assessed by visual analog scale (0-10)


Secondary Outcome Measures :
  1. Side effect compared between both group [ Time Frame: 6 month ]
  2. Patients satisfaction compare between both groups [ Time Frame: 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559480


Locations
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Thailand
Faculty of medicine Siriraj hospital, Mahidol university
Bangkok noi, Bangkok, Thailand, 10700
Siriraj hospital Mahidol university
Bangkok noi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Prasong Tanmahasamut, M.D. Mahidol University
More Information
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01559480    
Other Study ID Numbers: R015532018
First Posted: March 21, 2012    Key Record Dates
Last Update Posted: April 9, 2015
Last Verified: April 2015
Keywords provided by Mahidol University:
Endometriosis
Desogestrel
Placebo
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Desogestrel
Contraceptives, Oral, Hormonal
Contraceptives, Oral
 Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Contraceptives, Oral, Synthetic
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists