Deep Infiltrating Endometriosis (DIE)DIE-NISNCT01942369
A Study to Describe the Efficacy of Diphereline Following Conservative Surgery in Deep Infiltrating Endometriosis (DIE) Patients Over a Period of 24 Months
An observational study of Deep Infiltrating Endometriosis (DIE), run by Ipsen at 18 sites in China.
Trial summary
The purpose of this study is to describe changes in the intensity of specific endometriosis symptoms from baseline pre-surgery to after surgery and subsequent continuous Diphereline (Triptorelin Acetate) treatment for up to 24 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Deep Infiltrating Endometriosis (DIE)
- What is being tested?
- Triptorelin Acetate 3.75mg intramuscular injection
- Type of treatment
- Injection or infusion
- How many people
- 402 participants
- Where
- 18 sitesChina
- Study dates
- 16 Sep 2013to 13 Jul 2018
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Hospital patients who had been diagnosed with DIE, surgically treated and for whom decision has been made to be treated with a GnRHa post-surgery.
Who may be able to join
- Patients diagnosed with DIE and having received surgery treatment within one month before inclusion
- Premenopausal women aged >=18 years old.
- Written ICF has been obtained prior to any study-related procedures
- Patient for whom the treating physician already made the decision to treat by Diphereline.
- Patient should be mentally and physically able to express her symptom complaints and answer questions.
Who cannot join
- Pregnancy or lactation.
- Patients currently on treatment or who have been on therapy with a GnRHa in the last 6 months.
- Premenopausal women who may reach menopause within the 3 years post randomisation.
- Hypersensitivity to Triptorelin or one of the excipients of Triptorelin 3.75mg
- Treatment with another research drug over the last 3 months before the study
- Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites
Beijing Anzhen Hospital,Capital Medical University
Beijing, 100029
Peking University People's Hospital
Beijing, 100044
Beijing Jishuitan Hospital
Beijing, 100096
Chinese PLA General Hospital
Beijing, 100853
Xinqiao Hospital,Third Military Medical University
Chongqing, 400037
Southwest Hospital,Chongqing,400038
Chongqing, 400038
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, 310006
Anhui Provincial Cancer Hospital,Hefei,China,230031
Hefei, 230031
Jiangxi Maternal and Child Health Hospital,Nanchang
Nanchang, 330008
Nanjing Maternity and Child Health Care Hospital
Nanjing, 210011
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, 200011
The International Peace Maternity & Child Health Hospital of China
Shanghai, 200030
Shanghai First Maternity and Infant Hospital
Shanghai, 201204
Shenzhen People's Hospital
Shenzhen, 518020
The Second Hospital of Shanxi Medical University,Taiyuan
Taiyuan, 030001
Huazhong University of Science and Technology
Wuhan, 430022
Renmin Hospital of Wuhan University (Hubei General Hospital)
Wuhan, 430060
Henan Provincial People's Hospital
Zhengzhou, 450008
About this study
Official title: A Multi-centre, Prospective, Non-interventional Study to Describe the Efficacy of a Continuous up to 24-week Treatment of Diphereline 3.75mg Following Conservative Surgery in Deep Infiltrating Endometriosis (DIE) Patients Over a Period of 24 Months.
The purpose of this study is to describe changes in the intensity of specific endometriosis symptoms from baseline pre-surgery to after surgery and subsequent continuous Diphereline (Triptorelin Acetate) treatment for up to 24 weeks.
- Conditions
- Deep Infiltrating Endometriosis (DIE)
- Being tested
- Triptorelin Acetate 3.75mg intramuscular injection
- Keywords
- Endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptorelin Acetate 3.75mg intramuscular injectionDrug
Also called Diphereline 3.75mg intramuscular injection
Triptorelin Acetate is a Gonadotrophin Releasing Hormone agonist (GnRHa).
Triptorelin acetate for injection 3.75mg administered as described in the patient information sheet approved in China: one intramuscular injection of the product repeated every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Deep Infiltrating Endometriosis (DIE) | Not described Receives: Drug: Triptorelin Acetate 3.75mg intramuscular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the intensity of specific endometriosis symptoms from baseline pre-surgery
The specific endometriosis symptoms include pelvic pain, dysmenorrhoea, pain at time of ovulation, dyspareunia to be assessed with a 10-cm visual analogue scale (VAS).
Other symptoms (Amenorrhea, menorrhagia, metrorrhagia, Global GI symptoms \& urinary discomfort,) will be assessed by oral enquiry to the patients based on numerical scale from 0 to 10 (0 being the best and 10 the worst status).
Measured: Every 3 months in the first 12 months after surgery and every 6 months in the following 12 months
Secondary outcomes (5)
Recurrence rate of specific endometriosis symptoms
Recurrence rate of specific endometriosis symptoms in the group of patients with mild or null symptoms score following surgery and Diphereline treatment.
Measured: At 12 months and 24 months
Change during the study period in symptom(s) having the highest intensity at baseline
The highest intensity at baseline is defined as the symptom with the highest score on pre-surgery assessment.
Measured: 24 months
Rate of pregnancy in subjects
Measured: At 12 months and 24 months
Abdominal pain-free interval
Assessed using a visual analogue scale (VAS).
Measured: Every 3 months in the first 12 months after surgery and every 6 months in the following 12 months
Disease profile of DIE patients treated by Diphereline and by duration of treatment.
The disease profile (size of the lesion, locations etc…) will be detailed in each group of treatment duration by descriptive statistics.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study start16 Sep 2013
- Primary completion13 Jul 2018
- Study completion13 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Deep Infiltrating Endometriosis (DIE)Studies of the same condition, open and under way.
- More trials run by IpsenThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942369
- Sponsor's protocol ID
- A-38-52014-210
- Acronym
- DIE-NIS
- Status last verified
- Dec 2018
- First submitted
- 10 Sep 2013
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhu L, Guan Z, Huang Y, Hua K, Ma L, Zhang J, Yang D, Perrot V, Li H, Zhang X. The efficacy and safety of triptorelin-therapy following conservative surgery for deep infiltrating endometriosis: A multicenter, prospective, non-interventional study in China. Medicine (Baltimore). 2022 Feb 4;101(5):e28766. doi: 10.1097/MD.0000000000028766.
PubMed 35119037Sun W, Hua K, Hong L, Zhang J, Hao M, Wang J, Zhang J, Perrot V, Li H, Zhang X. Symptom control after different duration of triptorelin treatment following conservative surgery for deep infiltrating endometriosis: Post-hoc analysis of a multicentre, prospective, real-world study. Medicine (Baltimore). 2021 Jul 30;100(30):e26753. doi: 10.1097/MD.0000000000026753.
PubMed 34397719
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Prospective, Non-interventional Study to Describe the Efficacy of a Continuous up to 24-week Treatment of Diphereline 3.75mg Following Conservative Surgery in Deep Infiltrating Endometriosis (DIE) Patients Over a Period of 24 Months.
- ClinicalTrials.gov ID
- NCT01942369
- Acronym / sponsor ID
- DIE-NIS / A-38-52014-210
- Conditions
- Deep Infiltrating Endometriosis (DIE)
- Keywords
- Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2013
- Primary completion
- 13 Jul 2018 (actual)
- Study completion
- 13 Jul 2018 (actual)
- First posted
- 16 Sep 2013 (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 describe changes in the intensity of specific endometriosis symptoms from baseline pre-surgery to after surgery and subsequent continuous Diphereline (Triptorelin Acetate) treatment for up to 24 weeks.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Infiltrating Endometriosis (DIE) | – | Drug: Triptorelin Acetate 3.75mg intramuscular injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital patients who had been diagnosed with DIE, surgically treated and for whom decision has been made to be treated with a GnRHa post-surgery.
Key inclusion criteria (5 listed)
- Patients diagnosed with DIE and having received surgery treatment within one month before inclusion
- Premenopausal women aged >=18 years old.
- Written ICF has been obtained prior to any study-related procedures
- Patient for whom the treating physician already made the decision to treat by Diphereline.
- Patient should be mentally and physically able to express her symptom complaints and answer questions.
Key exclusion criteria (6 listed)
- Pregnancy or lactation.
- Patients currently on treatment or who have been on therapy with a GnRHa in the last 6 months.
- Premenopausal women who may reach menopause within the 3 years post randomisation.
- Hypersensitivity to Triptorelin or one of the excipients of Triptorelin 3.75mg
- Treatment with another research drug over the last 3 months before the study
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 |
|---|---|---|
| Triptorelin Acetate 3.75mg intramuscular injectionAlso: Diphereline 3.75mg intramuscular injectionTriptorelin Acetate is a Gonadotrophin Releasing Hormone agonist (GnRHa). Triptorelin acetate for injection 3.75mg administered as described in the patient information sheet approved in China: one intramuscular injection of the product repeated every 4 weeks. | Drug | Deep Infiltrating Endometriosis (DIE) |
Primary outcome
Changes in the intensity of specific endometriosis symptoms from baseline pre-surgery
Time frame: Every 3 months in the first 12 months after surgery and every 6 months in the following 12 months
The specific endometriosis symptoms include pelvic pain, dysmenorrhoea, pain at time of ovulation, dyspareunia to be assessed with a 10-cm visual analogue scale (VAS). Other symptoms (Amenorrhea, menorrhagia, metrorrhagia, Global GI symptoms \& urinary discomfort,) will be assessed by oral enquiry to the patients based on numerical scale from 0 to 10 (0 being the best and 10 the worst status).
5 secondary outcomes
Recurrence rate of specific endometriosis symptoms
Time frame: At 12 months and 24 months
Change during the study period in symptom(s) having the highest intensity at baseline
Time frame: 24 months
Rate of pregnancy in subjects
Time frame: At 12 months and 24 months
Abdominal pain-free interval
Time frame: Every 3 months in the first 12 months after surgery and every 6 months in the following 12 months
Disease profile of DIE patients treated by Diphereline and by duration of treatment.
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Derived from this study: PubMed 35119037Zhu L, Guan Z, Huang Y, Hua K, Ma L, Zhang J, Yang D, Perrot V, Li H, Zhang X. The efficacy and safety of triptorelin-therapy following conservative surgery for deep infiltrating endometriosis: A multicenter, prospective, non-interventional study in China. Medicine (Baltimore). 2022 Feb 4;101(5):e28766. doi: 10.1097/MD.0000000000028766.
- Derived from this study: PubMed 34397719Sun W, Hua K, Hong L, Zhang J, Hao M, Wang J, Zhang J, Perrot V, Li H, Zhang X. Symptom control after different duration of triptorelin treatment following conservative surgery for deep infiltrating endometriosis: Post-hoc analysis of a multicentre, prospective, real-world study. Medicine (Baltimore). 2021 Jul 30;100(30):e26753. doi: 10.1097/MD.0000000000026753.
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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.
Ipsen Medical Director study director
Ipsen
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Infiltrating Endometriosis (DIE), run by Ipsen at 18 sites 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the intensity of specific endometriosis symptoms from baseline pre-surgery (time frame: Every 3 months in the first 12 months after surgery and every 6 months in the following 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01942369, which also lists 2 linked publications.
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 6 Dec 2018.