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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
Results First Posted : October 14, 2021
Last Update Posted : October 14, 2021
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

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Study Type : Interventional
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

Arm Intervention/treatment
Experimental: 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).
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
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).
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) at Week 12 [ Time Frame: 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 :
  1. Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8 [ Time Frame: 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.

  2. Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12 [ Time Frame: 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.

  3. Change From Baseline in Endometriosis-associated Pelvic Pain at Weeks 4, 8 and 12 [ Time Frame: 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.

  4. Mean E2 Concentration at Weeks Baseline and 4, 8 and 12 [ Time Frame: Baseline (Day 1) and Weeks 4, 8 and 12 ]
    The mean serum E2 concentrations at baseline and Weeks 4, 8 and 12 are presented.

  5. Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12 [ Time Frame: Baseline (Day 1) and Weeks 4, 8 and 12 ]
    The mean FSH concentrations at baseline and Weeks 4, 8 and 12 are presented.

  6. Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12 [ Time Frame: Baseline and Weeks 4, 8 and 12 ]
    The mean LH concentrations at baseline and Weeks 4, 8 and 12 are presented.

  7. Median Time to Menses Recovery [ Time Frame: 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.



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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


Locations
Show Show 24 study locations
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
  Study Documents (Full-Text)

Documents provided by Ipsen:
Study Protocol  [PDF] September 29, 2017
Statistical Analysis Plan  [PDF] December 13, 2019

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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
Results First Posted: October 14, 2021
Last Update Posted: October 14, 2021
Last Verified: September 2021

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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
Contraceptive Agents, Hormonal
Antineoplastic Agents, Hormonal
Antineoplastic Agents