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Trial · Interventional

Status unknownPhase 4Registry data

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

NCTNCT00654524 (opens ClinicalTrials.gov in a new tab)Other idD8664L0001Other idChiCTR-TRC-00000068
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
60 participants (estimated)
Sponsor
Zhejiang University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
Mar 2008
Primary completion
Dec 2009 (estimated)
Completion
Dec 2010 (estimated)
First posted
8 Apr 2008 (estimated)
Last update posted
15 Mar 2011 (estimated)
Conditions
Endometriosis

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2008200920102011
  1. Ph 4

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

    NCT00654524

    Mar 2008 to est. Dec 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • gonadotropin-releasing-hormone agonist (GnRHa) - GoserelinDrug

Arms2

  • Experimental

    1

    Patients in this arm will be treated with goserelin depot-3.6mg plus add-back therapy.

  • No intervention

    2

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The recurrent rate of advanced endometriosis

    Time frame · within one year after surgery or GnRH-a management

Secondary outcomes(1)

  1. The pregnancy rate following laparoscopic surgery for advanced endometriosis

    Time frame · within one year after surgery or GnRH-a treatment

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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