- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03232281
Study to Compare the Oestradiol Suppression, Clinical Efficacy and Safety of Two Formulations of Triptorelin (Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month) in Chinese Subjects With Endometriosis
September 16, 2021 updated by: Ipsen
A Phase III, Multicentre, Randomised, Open-label, Parallel, Active-controlled Study to Compare the Oestradiol Suppression, Clinical Efficacy and Safety of Two Formulations of Triptorelin (Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month) in Chinese Subjects With Endometriosis
To assess the efficacy of triptorelin pamoate prolonged release (PR) 3-month formulation in Chinese female subjects with endometriosis by demonstrating the non-inferiority of triptorelin pamoate PR 3-month formulation injected once as compared to triptorelin acetate PR 1-month formulation injected 3 times consecutively.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100044
- Peking University People's Hospital
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Beijing, China, 100730
- Peking Union Medical College Hospital
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Beijing, China, 100191
- Peking University Third Hospital
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Beijing, China, 100034
- Peking University First Hospital
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Beijing, China, 100039
- Chinese PLA General Hospital
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Beijing, China, 100006
- Beijing Obstetrics and Gynecology Hospital, Capital Medical University
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Beijing, China, 100069
- Beijing Friendship Hospital, Capital Medical University
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Dalian, China, 116011
- The First Affiliated Hospital of Dalian Medical University
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Guangzhou, China, 510120
- The First Affiliated Hospital of Guangzhou Medical University
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Guangzhou, China, 510235
- Sun Yat-sen Memorial Hospital, Sun Yat-Sen University
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Guangzhou, China, 510630
- The Third Affiliated Hospital, Sun Yat-Sen University
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Haikou, China, 570311
- Hainan General Hospital
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Hangzhou, China, 310006
- Women's Hospital, School of Medicine Zhejiang University
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Hangzhou, China, 310020
- Sir Run Run Shaw Hospital School of Medicine, Zhejiang University
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Nanjing, China, 210004
- Nanjing Maternity and Child Health Care Hospital
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Nanjing, China, 210009
- Zhongda Hospital, Southeast University
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Nanning, China, 530021
- The people's hospital of Guangxi Zhuang Autonomous Region
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Shanghai, China, 200065
- Shanghai Tongji Hospital
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Shanghai, China, 200011
- Obstetrics and Gynaecology Hospital of Fudan University
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Shijiazhuang, China, 050000
- The second hospital of Hebei Medical University
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Tianjin, China, 300052
- Tianjin Medical University General Hospital
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Tianjin, China, 300211
- The Second Hospital of Tianjin Medical University
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Yangzhou, China, 225001
- Northern Jiangsu People's Hospital
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Yinchuan, China, 750004
- General Hospital of Ningxia Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female subjects aged from 18 to 45 years inclusive at the date of informed consent.
- A history of active and regular menstrual cycles of 21 to 35 days (inclusive) in the 6 months prior to the screening visit.
- A diagnosis of endometriosis, confirmed by laparoscopy or laparotomy within10 years prior to the screening visit.
- Requires treatment with a Gonadotrophin releasing hormone (GnRH) agonist for a period of 6 months in the judgement of the investigator.
Exclusion Criteria:
- A current history of undiagnosed abnormal genital bleeding.
- Received treatment with a GnRH agonist within 6 months prior to the screening visit.
- Received any other hormonal treatment within 3 months prior to the screening visit (oestrogens, progestogens, danazol, gestrinone and cyproterone acetate etc).
- Chronic pelvic pain that is not caused by endometriosis, that would interfere with the assessment of endometriosis-associated pelvic pain.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Triptorelin pamoate PR 3-month
Subjects received 15 mg triptorelin pamoate per injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
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15mg/injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections).
Other Names:
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Active Comparator: Triptorelin acetate PR 1-month
Subjects received 3.75 mg triptorelin acetate per injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
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3.75mg/injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12
Time Frame: Week 12
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Castration was defined as serum oestradiol (E2) ≤184 picomoles/litre (pmol/L) or 50 picograms/millilitre (pg/mL). The primary endpoint was evaluated based on centralised blinded bioanalysis of serum samples for E2. The percentage of subjects castrated and the 95% asymptotic confidence intervals (CIs), calculated from binomial distribution, are presented. |
Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8
Time Frame: Weeks 4 and 8
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The percentages of subjects who were castrated at Weeks 4 and 8 where castration was defined as serum E2 ≤184 pmol/L or 50 pg/mL are presented.
The 95% asymptotic CIs were calculated from the binomial distribution.
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Weeks 4 and 8
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Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12
Time Frame: Weeks 4, 8 and 12
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The percentages of subjects who were castrated at Weeks 4, 8 and 12 where castration was defined as serum E2 ≤110 pmol/L or 30 pg/mL are presented.
The 95% asymptotic CIs were calculated from the binomial distribution.
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Weeks 4, 8 and 12
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Change From Baseline in Endometriosis-associated Pelvic Pain at Weeks 4, 8 and 12
Time Frame: Baseline (Day 1) and Weeks 4, 8 and 12
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Endometriosis-associated pelvic pain was assessed using a 100 millimetres (mm) visual analogue scale (VAS) where subjects indicated the subjective level of their most severe endometriosis pain over the last 4 weeks by making a single vertical mark on the line ranging from 'absence of pain' (0 mm) to 'unbearable pain' (100 mm).
Lower scores indicated a better outcome.
Baseline was defined as the last available assessment prior to the first dose of study medication.
The least squares (LS) mean change from baseline at each timepoint as measured by the VAS is presented.
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Baseline (Day 1) and Weeks 4, 8 and 12
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Mean E2 Concentration at Weeks Baseline and 4, 8 and 12
Time Frame: Baseline (Day 1) and Weeks 4, 8 and 12
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The mean serum E2 concentrations at baseline and Weeks 4, 8 and 12 are presented.
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Baseline (Day 1) and Weeks 4, 8 and 12
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Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12
Time Frame: Baseline (Day 1) and Weeks 4, 8 and 12
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The mean FSH concentrations at baseline and Weeks 4, 8 and 12 are presented.
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Baseline (Day 1) and Weeks 4, 8 and 12
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Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12
Time Frame: Baseline and Weeks 4, 8 and 12
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The mean LH concentrations at baseline and Weeks 4, 8 and 12 are presented.
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Baseline and Weeks 4, 8 and 12
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Median Time to Menses Recovery
Time Frame: Baseline (Day 1) up to Week 40 (end of study visit)
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Time to menses recovery was defined as the time (in days) between the date of the last dose of study medication and the date of the first day the subject observed menstrual bleeding of the next menstrual period.
Menses recovery status was assessed at all study visits from Day 1 to the end of study visit.
The median time to menses recovery was analysed using the Kaplan-Meier method.
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Baseline (Day 1) up to Week 40 (end of study visit)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 28, 2017
Primary Completion (Actual)
May 17, 2019
Study Completion (Actual)
November 16, 2019
Study Registration Dates
First Submitted
July 25, 2017
First Submitted That Met QC Criteria
July 25, 2017
First Posted (Actual)
July 27, 2017
Study Record Updates
Last Update Posted (Actual)
October 14, 2021
Last Update Submitted That Met QC Criteria
September 16, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D-CN-52014-220
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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