Postoperative Desogestrel for Endometriosis Related Pain
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
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2012
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 12, 2012
CompletedFirst Posted
Study publicly available on registry
March 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedApril 9, 2015
April 1, 2015
2.8 years
March 12, 2012
April 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain score
Pain score will be assessed by visual analog scale (0-10)
6 months
Secondary Outcomes (2)
Side effect compared between both group
6 month
Patients satisfaction compare between both groups
6 months
Study Arms (2)
Desogestrel
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Desogestrel 75 mcg Takes 1 capsule before bedtime for 6 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- residual lesion after surgery which required further treatment
- cannot participate complete 6 months after surgery
- contraindication for Desogestrel, Paracetamol or Ponstan
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Faculty of medicine Siriraj hospital, Mahidol university
Bangkok Noi, Bangkok, 10700, Thailand
Siriraj hospital Mahidol university
Bangkok Noi, Bangkok, 10700, Thailand
Related Publications (1)
Chen I, Kives S, Zakhari A, Nguyen DB, Goldberg HR, Choudhry AJ, Le AL, Kowalczewski E, Schroll JB. Progestagens for pain symptoms associated with endometriosis. Cochrane Database Syst Rev. 2025 Oct 9;10(10):CD002122. doi: 10.1002/14651858.CD002122.pub3.
PMID: 41065045DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prasong Tanmahasamut, M.D.
Mahidol University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2012
First Posted
March 21, 2012
Study Start
January 1, 2012
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
April 9, 2015
Record last verified: 2015-04