Clinical trial NCT03232281: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometriosis
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2017-07-27
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8
timeFrame: Weeks 4 and 8
measure: Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12
timeFrame: Weeks 4, 8 and 12
measure: Change From Baseline in Endometriosis-associated Pelvic Pain at Weeks 4, 8 and 12
timeFrame: Baseline (Day 1) and Weeks 4, 8 and 12
measure: Mean E2 Concentration at Weeks Baseline and 4, 8 and 12
timeFrame: Baseline (Day 1) and Weeks 4, 8 and 12
measure: Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12
timeFrame: Baseline (Day 1) and Weeks 4, 8 and 12
measure: Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Median Time to Menses Recovery
timeFrame: Baseline (Day 1) up to Week 40 (end of study visit)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
city: Guangzhou
country: China
facility: The Third Affiliated Hospital, Sun Yat-sen University
city: Haikou
country: China
facility: Hainan General Hospital
city: Hangzhou
country: China
facility: Women's Hospital, School of Medicine Zhejiang University
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital school of medicine, Zhejiang University
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital
city: Nanjing
country: China
facility: Zhongda Hospital, Southeast University
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
city: Shanghai
country: China
facility: Obstetrics and Gynaecology Hospital of Fudan University
city: Shanghai
country: China
facility: Shanghai Tongji Hospital
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
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.