Randomized Study of Gonadotropin-releasing-hormone Agonist (GnRH-a) or Expectant Management for Endometriosis

Endometriosis Clinical Trial

Official title:

A Randomized Study Comparing Goserelin or Expectant Management Following Laparoscopic Surgery for Advanced Endometriosis

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00654524
• Other study ID #: D8664L0001
• Secondary ID: ChiCTR-TRC-00000
• Status: Unknown status
• Phase: Phase 4
• First received: April 2, 2008
• Last updated: March 14, 2011
• Start date: March 2008
• Est. completion date: December 2010

Study information

• Verified date: September 2008
• Source: Zhejiang University
• Contact: Xinmei Zhang, Prof.
• Phone: 0086-571-87061501
• Email: zhangxinm[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to identify the recurrent rate and pregnancy rate of advanced endometriosis after laparoscopic surgery plus GnRHa goserelin acetate treatment.

Description:

In order to decrease endometriosis recurrence and enhance pregnancy rate after surgical therapy, it has been proposed to use a post-surgical gonadotropin-releasing-hormone agonist (GnRHa) treatment. Data on the short-term recurrence of advanced endometriosis is rare. Although operative treatment has resulted in increasing pregnancy rate comparing non surgery management for moderate to severe endometriosis, very few data of spontaneous pregnancy rate are available comparing GnRHa treatment or expectant management after surgery treatment. In this situation, the investigators conduct a prospective, randomized, controlled study to determine whether postoperative GnRHa (goserelin acetate) therapy for advanced endometriosis is effective in reducing endometriosis recurrence rate and improving reproductive outcome.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age >=18 years old

• Normal menstruation for 3 months before enrollment (25-35 days)

• Advanced endometriosis confirmed histologically (r-AFS score III-IV) with laparoscopy or laparotomy-pelvic pain and/or dysmenorrhea and/or dyspareunia

• Agreement on the strict follow-up plan

• Without previous hormonal treatment

• Using nonhormonal method of contraception during this study

Exclusion Criteria:

• Serious heart diseases/pulmonary/liver/kidney diseases

• Previous non-endometriosis relevant surgery possibly influence to abdominal or pelvic pain

• Suspected malignancy in endometriosis

• Coagulation disorders with hemorrhagic tendency

• Pregnancy or lactation

• Allergy to GnRHa

• Previous ineffective treatment with GnRHa

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin
The patient will be managed with GnRH-a injection (Goserelin 3.6mg) every 4 weeks for 6 months plus add-back therapy (Caltrate With Vitamin D 600mg p.o. q.d.& Livial 1.25-2.5mg p.o. q.d.) if needed.

Locations

Country	Name	City	State
China	Women's Hospital School Of Medicine Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The recurrent rate of advanced endometriosis		within one year after surgery or GnRH-a management
Secondary	The pregnancy rate following laparoscopic surgery for advanced endometriosis		within one year after surgery or GnRH-a treatment