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
- Conditions
- Endometriosis
- Interventions
- Registration Number
- NCT03232281
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 300
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Triptorelin pamoate PR 3-month 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 acetate PR 1-month 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).
- Primary Outcome Measures
Name Time Method Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12 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
Name Time Method Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12 Baseline (Day 1) and Weeks 4, 8 and 12 The mean FSH concentrations at baseline and Weeks 4, 8 and 12 are presented.
Median Time to Menses Recovery Baseline (Day 1) up to Week 40 (end of study visit) 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.
Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12 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 Baseline (Day 1) and 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 Baseline (Day 1) and Weeks 4, 8 and 12 The mean serum E2 concentrations at baseline and Weeks 4, 8 and 12 are presented.
Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12 Baseline and Weeks 4, 8 and 12 The mean LH concentrations at baseline and Weeks 4, 8 and 12 are presented.
Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8 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.
Trial Locations
- Locations (24)
Chinese PLA General Hospital
🇨🇳Beijing, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
Peking University Third Hospital
🇨🇳Beijing, China
Obstetrics and Gynaecology Hospital of Fudan University
🇨🇳Shanghai, 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
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
🇨🇳Beijing, China
Peking University People's Hospital
🇨🇳Beijing, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, 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
The People's Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, China
Shanghai Tongji Hospital
🇨🇳Shanghai, China
Zhongda Hospital, Southeast University
🇨🇳Nanjing, China
Peking University First Hospital
🇨🇳Beijing, China