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

NCT00654524 | Unknown Phase 4 DMC

• 2 other identifiers: D8664L0001ChiCTR-TRC-00000068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis

Keywords

Endometriosis; Recurrence; Pregnancy Rate; Laparoscopy; Gonadotropin-Releasing Hormone

Outcome Measures

Primary Outcomes (1)

• The recurrent rate of advanced endometriosis

  within one year after surgery or GnRH-a management

Secondary Outcomes (1)

• The pregnancy rate following laparoscopic surgery for advanced endometriosis

  within one year after surgery or GnRH-a treatment

Study Arms (2)

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

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.

Interventions

gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin DRUG

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.

Also known as: Goserelin, Caltrate With Vitamin D 600, Livial

1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Conditions

Endometriosis; Recurrence

Interventions

Gonadotropin-Releasing Hormone; Goserelin; Calcium Carbonate; tibolone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Xinmei Zhang, Prof.

  Women's Hospital School Of Medicine Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinmei Zhang, Prof.

CONTACT

0086-571-87061501; zhangxinm@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 8, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: March 15, 2011

Record last verified: 2008-09

Locations

CN (1)