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
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
1 other identifier
interventional
300
1 country
24
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2017
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2017
CompletedFirst Posted
Study publicly available on registry
July 27, 2017
CompletedStudy Start
First participant enrolled
July 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2019
CompletedResults Posted
Study results publicly available
October 14, 2021
CompletedOctober 14, 2021
September 1, 2021
1.8 years
July 25, 2017
September 16, 2021
September 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12
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
Secondary Outcomes (7)
Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8
Weeks 4 and 8
Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12
Weeks 4, 8 and 12
Change From Baseline in Endometriosis-associated Pelvic Pain at Weeks 4, 8 and 12
Baseline (Day 1) and Weeks 4, 8 and 12
Mean E2 Concentration at Weeks Baseline and 4, 8 and 12
Baseline (Day 1) and Weeks 4, 8 and 12
Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12
Baseline (Day 1) and Weeks 4, 8 and 12
- +2 more secondary outcomes
Study Arms (2)
Triptorelin pamoate PR 3-month
EXPERIMENTALSubjects 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).
Triptorelin acetate PR 1-month
ACTIVE COMPARATORSubjects 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).
Interventions
15mg/injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections).
3.75mg/injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (24)
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, 100006, China
Peking University First Hospital
Beijing, 100034, China
Chinese PLA General Hospital
Beijing, 100039, China
Peking University People's Hospital
Beijing, 100044, China
Beijing Friendship Hospital, Capital Medical University
Beijing, 100069, China
Peking University Third Hospital
Beijing, 100191, China
Peking Union Medical College Hospital
Beijing, 100730, China
The First Affiliated Hospital of Dalian Medical University
Dalian, 116011, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, 510235, China
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, 510630, China
Hainan General Hospital
Haikou, 570311, China
Women's Hospital, School of Medicine Zhejiang University
Hangzhou, 310006, China
Sir Run Run Shaw Hospital school of medicine, Zhejiang University
Hangzhou, 310020, China
Nanjing Maternity and Child Health Care Hospital
Nanjing, 210004, China
Zhongda Hospital, Southeast University
Nanjing, 210009, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, 530021, China
Obstetrics and Gynaecology Hospital of Fudan University
Shanghai, 200011, China
Shanghai Tongji Hospital
Shanghai, 200065, China
The Second Hospital of Hebei Medical University
Shijiazhuang, 050000, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
The Second Hospital of Tianjin Medical University
Tianjin, 300211, China
Northern Jiangsu People's Hospital
Yangzhou, 225001, China
General Hospital of Ningxia Medical University
Yinchuan, 750004, China
Related Publications (1)
Li X, Li H, Shi H, Li X, Zhou R, Lu D, Cai Y, Zhou Y, Cabri P, Shi X, Pedret-Dunn A, Leng J. Assessment of Two Formulations of Triptorelin in Chinese Patients with Endometriosis: A Phase 3, Randomized Controlled Trial. Adv Ther. 2022 Oct;39(10):4663-4677. doi: 10.1007/s12325-022-02264-5. Epub 2022 Aug 10.
PMID: 35947347DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Ipsen Pharma
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2017
First Posted
July 27, 2017
Study Start
July 28, 2017
Primary Completion
May 17, 2019
Study Completion
November 16, 2019
Last Updated
October 14, 2021
Results First Posted
October 14, 2021
Record last verified: 2021-09