Postoperative Desogestrel for Endometriosis Related Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-10-31

Brief Summary

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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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Detailed Description

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

Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Desogestrel

Group Type ACTIVE_COMPARATOR

Desogestrel

Intervention Type DRUG

Desogestrel 75 mcg Takes 1 capsule before bedtime for 6 months

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsule takes 1 capsule before bedtime for 6 months

Interventions

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Desogestrel

Desogestrel 75 mcg Takes 1 capsule before bedtime for 6 months

Intervention Type DRUG

Placebo

Placebo capsule takes 1 capsule before bedtime for 6 months

Intervention Type DRUG

Other Intervention Names

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Cerazette

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No