EndometriosisPhase 4NCT00654524
Randomized Study of Gonadotropin-releasing-hormone Agonist (GnRH-a) or Expectant Management for Endometriosis
A Phase 4 study testing gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin in people with Endometriosis, run by Zhejiang University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Mar 2008to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006
Xinmei Zhang, Prof., 0086-571-87061501 ext. 2131, zhangxinm@zju.edu.cn
Xiufeng Huang, A/Prof.
About this study
Official title: A Randomized Study Comparing Goserelin or Expectant Management Following Laparoscopic Surgery for Advanced Endometriosis
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.
Read the 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, 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.
- Conditions
- Endometriosis
- Being tested
- gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin
- Keywords
- Endometriosis, Recurrence, Pregnancy Rate, Laparoscopy, Gonadotropin-Releasing Hormone
- Medical subject headings
- Endometriosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gonadotropin-releasing-hormone agonist (GnRHa) - GoserelinDrug
Also called Goserelin, Caltrate With Vitamin D 600, Livial
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients in this arm will be treated with goserelin depot-3.6mg plus add-back therapy. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrent rate of advanced endometriosis
Measured: within one year after surgery or GnRH-a management
Secondary outcomes (1)
The pregnancy rate following laparoscopic surgery for advanced endometriosis
Measured: within one year after surgery or GnRH-a treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Investigators
- Xinmei Zhang, Prof., Principal investigator, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654524
- Sponsor's protocol ID
- D8664L0001
- Other IDs
- ChiCTR-TRC-00000068
- Status last verified
- Sep 2008
- First submitted
- 2 Apr 2008
- Last updated
- 15 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Comparing Goserelin or Expectant Management Following Laparoscopic Surgery for Advanced Endometriosis
- ClinicalTrials.gov ID
- NCT00654524
- Acronym / sponsor ID
- D8664L0001
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Recurrence, Pregnancy Rate, Laparoscopy, Gonadotropin-Releasing Hormone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 8 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: gonadotropin-releasing-hormone agonist (GnRHa) - GoserelinPatients in this arm will be treated with goserelin depot-3.6mg plus add-back therapy. |
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gonadotropin-releasing-hormone agonist (GnRHa) - GoserelinAlso: Goserelin, Caltrate With Vitamin D 600, LivialThe 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. | Drug | 1 |
Primary outcome
The recurrent rate of advanced endometriosis
Time frame: within one year after surgery or GnRH-a management
1 secondary outcome
The pregnancy rate following laparoscopic surgery for advanced endometriosis
Time frame: within one year after surgery or GnRH-a treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinmei Zhang, Prof. principal investigator
Women's Hospital School Of Medicine Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin in people with Endometriosis, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinmei Zhang, Prof. (0086-571-87061501 ext. 2131, zhangxinm@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The recurrent rate of advanced endometriosis (time frame: within one year after surgery or GnRH-a management). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2011.