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Postoperative Desogestrel for Endometriosis Related Pain

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01559480
First received: March 12, 2012
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  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 capsule

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

MedlinePlus related topics: Endometriosis
Drug Information available for: Desogestrel
U.S. FDA Resources

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 ]

Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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 capsule
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
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
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: March 20, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Endometriosis
Desogestrel
Placebo

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

ClinicalTrials.gov processed this record on May 23, 2013