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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03232281
• Other study ID #: D-CN-52014-220
• Status: Completed
• Phase: Phase 3
• Start date: July 28, 2017
• Est. completion date: November 16, 2019

Study information

• Verified date: September 2021
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 16, 2019
• Est. primary completion date: May 17, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing
China	Beijing Obstetrics and Gynecology Hospital, Capital Medical University	Beijing
China	Chinese PLA General Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing
China	Peking University First Hospital	Beijing
China	Peking University People's Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	The First Affiliated Hospital of Dalian Medical University	Dalian
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	The Third Affiliated Hospital, Sun Yat-sen University	Guangzhou
China	Hainan General Hospital	Haikou
China	Sir Run Run Shaw Hospital school of medicine, Zhejiang University	Hangzhou
China	Women's 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	The Second Hospital of Tianjin Medical University	Tianjin
China	Tianjin Medical University General Hospital	Tianjin
China	Northern Jiangsu People's Hospital	Yangzhou
China	General Hospital of Ningxia Medical University	Yinchuan

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Weeks 4 and 8
Secondary	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.	Weeks 4, 8 and 12
Secondary	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.	Baseline (Day 1) and Weeks 4, 8 and 12
Secondary	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.	Baseline (Day 1) and Weeks 4, 8 and 12
Secondary	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.	Baseline (Day 1) and Weeks 4, 8 and 12
Secondary	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.	Baseline and Weeks 4, 8 and 12
Secondary	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.	Baseline (Day 1) up to Week 40 (end of study visit)