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
NCT ID: NCT03232281
Last Updated: 2021-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2017-07-28
2019-11-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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).
Triptorelin Pamoate PR 3-month
15mg/injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections).
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).
Triptorelin Acetate PR 1-month
3.75mg/injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections)
Interventions
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Triptorelin Pamoate PR 3-month
15mg/injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections).
Triptorelin Acetate PR 1-month
3.75mg/injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
FEMALE
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, , China
Peking University First Hospital
Beijing, , China
Chinese PLA General Hospital
Beijing, , China
Peking University People's Hospital
Beijing, , China
Beijing Friendship Hospital, Capital Medical University
Beijing, , China
Peking University Third Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
The First Affiliated Hospital of Dalian Medical University
Dalian, , China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, , China
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, , China
Hainan General Hospital
Haikou, , China
Women's Hospital, School of Medicine Zhejiang University
Hangzhou, , China
Sir Run Run Shaw Hospital school of medicine, Zhejiang University
Hangzhou, , China
Nanjing Maternity and Child Health Care Hospital
Nanjing, , China
Zhongda Hospital, Southeast University
Nanjing, , China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, , China
Obstetrics and Gynaecology Hospital of Fudan University
Shanghai, , China
Shanghai Tongji Hospital
Shanghai, , China
The Second Hospital of Hebei Medical University
Shijiazhuang, , China
Tianjin Medical University General Hospital
Tianjin, , China
The Second Hospital of Tianjin Medical University
Tianjin, , China
Northern Jiangsu People's Hospital
Yangzhou, , China
General Hospital of Ningxia Medical University
Yinchuan, , China
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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D-CN-52014-220
Identifier Type: -
Identifier Source: org_study_id