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NCT Number: NCT01559480

Postoperative Desogestrel for Endometriosis Related Pain

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine Siriraj hospital, Mahidol university, Bangkok Noi, Bangkok, Thailand

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desogestrel

Drug

Desogestrel 75 mcg Takes 1 capsule before bedtime for 6 months

Other names: Cerazette

Placebo

Drug

Placebo capsule takes 1 capsule before bedtime for 6 months

Primary outcomes

  1. Pain score

    Time frame: 6 months

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

Secondary outcomes

  1. Side effect compared between both group

    Time frame: 6 month

  2. Patients satisfaction compare between both groups

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 21, 2012
Registry last updated
Apr 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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