Back to resultsStudy 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
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Triptorelin Pamoate PR 3-month
Triptorelin Acetate PR 1-month
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis
Eligibility Criteria
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.
Sites / Locations
- Beijing Obstetrics and Gynecology Hospital, Capital Medical University
- Peking University First Hospital
- Chinese PLA General Hospital
- Peking University People's Hospital
- Beijing Friendship Hospital, Capital Medical University
- Peking University Third Hospital
- Peking Union Medical College Hospital
- The First Affiliated Hospital of Dalian Medical University
- The First Affiliated Hospital of Guangzhou Medical University
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- The Third Affiliated Hospital, Sun Yat-sen University
- Hainan General Hospital
- Women's Hospital, School of Medicine Zhejiang University
- Sir Run Run Shaw Hospital school of medicine, Zhejiang University
- Nanjing Maternity and Child Health Care Hospital
- Zhongda Hospital, Southeast University
- The People's Hospital of Guangxi Zhuang Autonomous Region
- Obstetrics and Gynaecology Hospital of Fudan University
- Shanghai Tongji Hospital
- The Second Hospital of Hebei Medical University
- Tianjin Medical University General Hospital
- The Second Hospital of Tianjin Medical University
- Northern Jiangsu People's Hospital
- General Hospital of Ningxia Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Triptorelin pamoate PR 3-month
Triptorelin acetate PR 1-month
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8
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.
Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12
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.
Change From Baseline in Endometriosis-associated Pelvic Pain at Weeks 4, 8 and 12
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.
Mean E2 Concentration at Weeks Baseline and 4, 8 and 12
The mean serum E2 concentrations at baseline and Weeks 4, 8 and 12 are presented.
Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12
The mean FSH concentrations at baseline and Weeks 4, 8 and 12 are presented.
Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12
The mean LH concentrations at baseline and Weeks 4, 8 and 12 are presented.
Median Time to Menses Recovery
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03232281
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 28, 2017 (Actual)
Primary Completion Date
May 17, 2019 (Actual)
Study Completion Date
November 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Triptorelin pamoate PR 3-month
Arm Type
Experimental
Arm Description
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).
Arm Title
Triptorelin acetate PR 1-month
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Triptorelin Pamoate PR 3-month
Other Intervention Name(s)
Triptorelin pamoate for injection 15 mg
Intervention Description
15mg/injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections).
Intervention Type
Drug
Intervention Name(s)
Triptorelin Acetate PR 1-month
Other Intervention Name(s)
Diphereline 3.75 mg
Intervention Description
3.75mg/injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections)
Primary Outcome Measure Information:
Title
Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8
Description
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.
Time Frame
Weeks 4 and 8
Title
Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12
Description
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.
Time Frame
Weeks 4, 8 and 12
Title
Change From Baseline in Endometriosis-associated Pelvic Pain at Weeks 4, 8 and 12
Description
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.
Time Frame
Baseline (Day 1) and Weeks 4, 8 and 12
Title
Mean E2 Concentration at Weeks Baseline and 4, 8 and 12
Description
The mean serum E2 concentrations at baseline and Weeks 4, 8 and 12 are presented.
Time Frame
Baseline (Day 1) and Weeks 4, 8 and 12
Title
Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12
Description
The mean FSH concentrations at baseline and Weeks 4, 8 and 12 are presented.
Time Frame
Baseline (Day 1) and Weeks 4, 8 and 12
Title
Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12
Description
The mean LH concentrations at baseline and Weeks 4, 8 and 12 are presented.
Time Frame
Baseline and Weeks 4, 8 and 12
Title
Median Time to Menses Recovery
Description
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.
Time Frame
Baseline (Day 1) up to Week 40 (end of study visit)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100006
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100069
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
ZIP/Postal Code
116011
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
ZIP/Postal Code
510235
Country
China
Facility Name
The Third Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
ZIP/Postal Code
510630
Country
China
Facility Name
Hainan General Hospital
City
Haikou
ZIP/Postal Code
570311
Country
China
Facility Name
Women's Hospital, School of Medicine Zhejiang University
City
Hangzhou
ZIP/Postal Code
310006
Country
China
Facility Name
Sir Run Run Shaw Hospital school of medicine, Zhejiang University
City
Hangzhou
ZIP/Postal Code
310020
Country
China
Facility Name
Nanjing Maternity and Child Health Care Hospital
City
Nanjing
ZIP/Postal Code
210004
Country
China
Facility Name
Zhongda Hospital, Southeast University
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
The People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
ZIP/Postal Code
530021
Country
China
Facility Name
Obstetrics and Gynaecology Hospital of Fudan University
City
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
Shanghai Tongji Hospital
City
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
ZIP/Postal Code
050000
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
The Second Hospital of Tianjin Medical University
City
Tianjin
ZIP/Postal Code
300211
Country
China
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
ZIP/Postal Code
225001
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
ZIP/Postal Code
750004
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
35947347
Citation
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.
Results Reference
derived
Learn more about this trial
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
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