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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 : Active, not recruiting
First Posted : July 27, 2017
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date  ICMJE July 25, 2017
First Posted Date  ICMJE July 27, 2017
Last Update Posted Date June 27, 2019
Actual Study Start Date  ICMJE July 28, 2017
Actual Primary Completion Date May 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03232281 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • Percentage of subjects castrated (E2≤184 pmol/L or 50 pg/mL) at Weeks 4 and 8. [ Time Frame: Week 4 and 8 ]
  • 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 ]
  • Change in endometriosis-associated pelvic pain (by 10 cm visual analogue scale (VAS)) [ Time Frame: Week 4, 8 and 12 compared to baseline ]
  • Oestradiol (E2) concentration [ Time Frame: Week 4, 8 and 12 ]
  • Follicle stimulating hormone (FSH) concentration [ Time Frame: Week 4, 8 and 12 ]
  • Luteinising hormone (LH) concentration [ Time Frame: Week 4, 8 and 12 ]
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2017)
  • Percentage of subjects castrated (E2≤184 pmol/L or 50 pg/mL) at Weeks 4 and 8. [ Time Frame: Week 4 and 8 ]
  • 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 ]
  • Change in endometriosis-associated pelvic pain (by 10 cm visual analogue scale (VAS)) [ Time Frame: Week 4, 8 and 12 compared to baseline ]
  • Follicle stimulating hormone (FSH) concentration [ Time Frame: Week 4, 8 and 12 ]
  • Luteinising hormone (LH) concentration [ Time Frame: Week 4, 8 and 12 ]
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: triptorelin pamoate PR 3-month
    Intervention: Drug: Triptorelin Pamoate PR 3-month
  • Active Comparator: triptorelin acetate PR 1-month
    Intervention: Drug: Triptorelin Acetate PR 1-month
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 25, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2019
Actual Primary Completion Date May 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03232281
Other Study ID Numbers  ICMJE D-CN-52014-220
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ipsen
Study Sponsor  ICMJE Ipsen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP