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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 : Completed
First Posted : July 27, 2017
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : May 17, 2019
Actual Study Completion Date : November 16, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arms and Interventions
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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


Outcome Measures
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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.


Eligibility Criteria
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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.
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
More Information
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03232281    
Other Study ID Numbers: D-CN-52014-220
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
 Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents