Randomized Study of Gonadotropin-Releasing-Hormone Agonist (GnRH-a) or Expectant Management for Endometriosis - Full Text View

Sponsored by:	Zhejiang University
Information provided by:	Zhejiang University
ClinicalTrials.gov Identifier:	NCT00654524

Purpose

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.

Condition	Intervention	Phase
Endometriosis	Drug: gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin	Phase IV

MedlinePlus related topics: Endometriosis

Drug Information available for: Vitamin D Ergocalciferol Calcium carbonate Goserelin Gonadorelin Gonadorelin hydrochloride LH-RH Tibolone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Study Comparing Goserelin or Expectant Management Following Laparoscopic Surgery for Advanced Endometriosis

Further study details as provided by Zhejiang University:

Primary Outcome Measures:

The recurrent rate of advanced endometriosis [ Time Frame: within one year after surgery or GnRH-a management ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The pregnancy rate following laparoscopic surgery for advanced endometriosis [ Time Frame: within one year after surgery or GnRH-a treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients in this arm will be treated with goserelin depot-3.6mg plus add-back therapy.	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.
2: No Intervention The patient with advanced endometriosis（stage III-IV）confirmed histologically after conservative laparoscopic surgery will be suggested to prepare for spontaneous pregnancy rather than any medical administration.

Detailed 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, we 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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age >=18 years
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 uneffective treatment with GnRHa

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654524

Contacts

Contact: Xinmei Zhang, Prof.

0086-571-87061501 ext 2131

zhangxinm@zju.edu.cn

Locations

China, Zhejiang
Women's Hospital School Of Medicine Zhejiang University	Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Xinmei Zhang, Prof. 0086-571-87061501 ext 2131 zhangxinm@zju.edu.cn
Sub-Investigator: Xiufeng Huang, A/Prof.

Sponsors and Collaborators

Zhejiang University

Investigators

Principal Investigator:

Xinmei Zhang, Prof.

Women's Hospital School Of Medicine Zhejiang University

More Information

Responsible Party:	Women's Hospital School of Medicine Zhejiang University ( XINMEI ZHANG )
Study ID Numbers:	D8664L0001, ChiCTR-TRC-00000068
Study First Received:	April 2, 2008
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00654524
Health Authority:	China: Ethics Committee

Keywords provided by Zhejiang University:

Endometriosis
Recurrence
Pregnancy Rate
Laparoscopy
Gonadotropin-Releasing Hormone

Study placed in the following topic categories:

Genital Diseases, Female
Tibolone
Vitamin D
Goserelin

Ergocalciferols
Endometriosis
Calcium Carbonate
Recurrence

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009