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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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ClinicalTrials.gov Identifier: NCT03232281
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Triptorelin Pamoate PR 3-month Drug: Triptorelin Acetate PR 1-month Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 28, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: triptorelin pamoate PR 3-month Drug: Triptorelin Pamoate PR 3-month
15mg/injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections).
Other Name: Triptorelin pamoate for injection 15 mg

Active Comparator: triptorelin acetate PR 1-month Drug: Triptorelin Acetate PR 1-month
3.75mg/injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections)
Other Name: Diphereline 3.75 mg




Primary Outcome Measures :
  1. Percentage of subjects castrated (E2≤184 pmol/L or 50 pg/mL) [ Time Frame: Week 12 ]
    Evaluated based on centralised blinded bioanalysis of serum samples for E2.


Secondary Outcome Measures :
  1. Percentage of subjects castrated (E2≤184 pmol/L or 50 pg/mL) at Weeks 4 and 8. [ Time Frame: Week 4 and 8 ]
  2. Percentage of subjects castrated (E2≤110 pmol/L or 30 pg/mL) at Weeks 4, 8 and 12. [ Time Frame: Week 4, 8 and 12 ]
  3. Change in endometriosis-associated pelvic pain (by 10 cm visual analogue scale (VAS)) [ Time Frame: Week 4, 8 and 12 compared to baseline ]
  4. Oestradiol (E2) concentration [ Time Frame: Week 4, 8 and 12 ]
  5. Follicle stimulating hormone (FSH) concentration [ Time Frame: Week 4, 8 and 12 ]
  6. Luteinising hormone (LH) concentration [ Time Frame: Week 4, 8 and 12 ]
  7. Time to menses recovery [ Time Frame: Baseline, date of first observation of menstrual bleeding at Week 28, 32, 36 and end of study/early withdrawal (up to 40 weeks) ]
    Time to menses recovery will be defined as the time (in days) between date of first dose of study drug and date of first day the subject observed menstrual bleeding of the next menstrual period.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03232281


Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
China
Beijing Obstetrics and Gynecology Hospital, Capital Medical University Recruiting
Beijing, China, 100006
China-Japan Friendship Hospital Terminated
Beijing, China, 100029
Peking University First Hospital Recruiting
Beijing, China, 100034
Chinese PLA General Hospital Recruiting
Beijing, China, 100039
Peking University People's Hospital Recruiting
Beijing, China, 100044
Beijing Friendship Hospital, Capital Medical University Recruiting
Beijing, China, 100069
Peking University Third Hospital Recruiting
Beijing, China, 100191
Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
The First Affiliated Hospital of Dalian Medical University Recruiting
Dalian, China, 116011
The First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, China, 510120
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Recruiting
Guangzhou, China, 510235
The Third Affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou, China, 510630
Hainan General Hospital Recruiting
Haikou, China, 570311
Women's Hospital, School of Medicine Zhejiang University Recruiting
Hangzhou, China, 310006
Sir Run Run Shaw Hospital school of medicine, Zhejiang University Recruiting
Hangzhou, China, 310020
Nanjing Maternity and Child Health Care Hospital Recruiting
Nanjing, China, 210004
Zhongda Hospital, Southeast University Recruiting
Nanjing, China, 210009
The People's Hospital of Guangxi Zhuang Autonomous Region Recruiting
Nanning, China, 530021
Obstetrics and Gynaecology Hospital of Fudan University Recruiting
Shanghai, China, 200011
Shanghai Tongji Hospital Recruiting
Shanghai, China, 200065
The Second Hospital of Hebei Medical University Recruiting
Shijiazhuang, China, 050000
Tianjin Medical University General Hospital Recruiting
Tianjin, China, 300052
The Second Hospital of Tianjin Medical University Recruiting
Tianjin, China, 300211
Northern Jiangsu People's Hospital Recruiting
Yangzhou, China, 225001
General Hospital of Ningxia Medical University Recruiting
Yinchuan, China, 750004
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Qiuju Yuan, M.D. Ipsen

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03232281     History of Changes
Other Study ID Numbers: D-CN-52014-220
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Genital Diseases, Female
Endometriosis
Estradiol
Triptorelin Pamoate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents