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Completed

NCT Number: NCT03232281

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

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Friendship Hospital, Capital Medical University, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triptorelin Pamoate PR 3-month

Drug

15mg/injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections).

Other names: Triptorelin pamoate for injection 15 mg

Triptorelin Acetate PR 1-month

Drug

3.75mg/injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections)

Other names: Diphereline 3.75 mg

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 27, 2017
Registry last updated
Oct 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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