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

Ipsen300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

300

Conditions

Endometriosis

Interventions

Triptorelin Pamoate PR 3-monthDRUG

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

Triptorelin Acetate PR 1-monthDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (24)

Beijing Obstetrics and Gynecology Hospital, Capital Medical University

Beijing, China

Outcomes

Primary Outcomes

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

Time frame: Week 12

Secondary Outcomes

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

Time frame: Weeks 4 and 8

Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at 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.

Time frame: Weeks 4, 8 and 12

Change From Baseline in Endometriosis-associated Pelvic Pain at 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.

Time frame: Baseline (Day 1) and Weeks 4, 8 and 12

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

Data from ClinicalTrials.gov

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