Postoperative Desogestrel for Endometriosis Related Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01559480
First received: March 12, 2012
Last updated: April 8, 2015
Last verified: April 2015
  Purpose

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 Intervention
Endometriosis
Drug: Desogestrel
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Pain score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Pain score will be assessed by visual analog scale (0-10)


Secondary Outcome Measures:
  • Side effect compared between both group [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • Patients satisfaction compare between both groups [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: January 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559480

Locations
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
Principal Investigator: Prasong Tanmahasamut, M.D. Mahidol University
  More Information

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01559480     History of Changes
Other Study ID Numbers: R015532018
Study First Received: March 12, 2012
Last Updated: April 8, 2015
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Endometriosis
Desogestrel
Placebo

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Desogestrel
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 29, 2015