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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT03232281 (opens ClinicalTrials.gov in a new tab)Other idD-CN-52014-220
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
300 participants (actual)
Sponsor
Ipsen · Industry
Design
Randomized · Single masking
Countries
1 country

China

Start
28 Jul 2017
Primary completion
17 May 2019
Completion
16 Nov 2019
First posted
27 Jul 2017
Last update posted
14 Oct 2021
Conditions
Endometriosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020
  1. Ph 3

    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

    NCT03232281

    28 Jul 2017 to 16 Nov 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Triptorelin Pamoate PR 3-monthDrug
  • Triptorelin Acetate PR 1-monthDrug

Arms2

  • 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).

  • 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).

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12

    Time frame · Week 12

    Registry description

    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 outcomes(7)

  1. Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8

    Time frame · Weeks 4 and 8

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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)

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Week 12

Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12

GroupValue (percentage of subjects)
Triptorelin Pamoate PR 3-month98.6
Triptorelin Acetate PR 1-month99.3
Secondary and other outcome results(7)
Secondary outcomeNumber· Weeks 4 and 8

Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8

GroupValue (percentage of subjects)
Triptorelin Pamoate PR 3-month98.0
Triptorelin Acetate PR 1-month99.3
Secondary outcomeNumber· Weeks 4, 8 and 12

Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12

GroupValue (percentage of subjects)
Triptorelin Pamoate PR 3-month98.0
Triptorelin Acetate PR 1-month99.3
Secondary outcomeLeast squares mean· Baseline (Day 1) and Weeks 4, 8 and 12

Change From Baseline in Endometriosis-associated Pelvic Pain at Weeks 4, 8 and 12

GroupValue (mm)
Triptorelin Pamoate PR 3-month-24.4
Triptorelin Acetate PR 1-month-24.4
Secondary outcomeMean· Baseline (Day 1) and Weeks 4, 8 and 12

Mean E2 Concentration at Weeks Baseline and 4, 8 and 12

GroupValue (pmol/L)Spread
Triptorelin Pamoate PR 3-month192.302258.209
Triptorelin Acetate PR 1-month218.893296.825
Secondary outcomeMean· Baseline (Day 1) and Weeks 4, 8 and 12

Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12

GroupValue (International Units/L (IU/L))Spread
Triptorelin Pamoate PR 3-month6.0993.929
Triptorelin Acetate PR 1-month6.2584.520
Secondary outcomeMean· Baseline and Weeks 4, 8 and 12

Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12

GroupValue (IU/L)Spread
Triptorelin Pamoate PR 3-month3.3761.902
Triptorelin Acetate PR 1-month3.4871.858
Secondary outcomeMedian· Baseline (Day 1) up to Week 40 (end of study visit)

Median Time to Menses Recovery

GroupValue (days)
Triptorelin Pamoate PR 3-month179.0
Triptorelin Acetate PR 1-month85.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Triptorelin Pamoate PR 3-monthSubjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).0 / 1492 / 149132 / 149
Triptorelin Acetate PR 1-monthSubjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).0 / 1501 / 150135 / 150

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

6 results

Assessment of Two Formulations of Triptorelin in Chinese Patients with Endometriosis: A Phase 3, Randomized Controlled Trial.

Li et al. 2022Advances in therapycited by 7

PMID 35947347PMC9464738DOI 10.1007/s12325-022-02264-5PUB-35947347

Free to read · publisher termsCC BY-NC6 results
Read at sourceSee results (6)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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