Phase 3
Completed N=300
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
Source: ClinicalTrials.gov NCT03232281 ↗Enrolled (actual)
300
Serious AEs
1.0%
Results posted
Oct 2021
Primary outcomePrimary: Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12 — 98.6; 99.3 percentage of subjects
◆ Published Evidence
Emerging
6citations · ~2 / year
Assessment of Two Formulations of Triptorelin in Chinese Patients with Endometriosis: A Phase 3, Randomized Controlled Trial.
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.
Linked Publications
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Assessment of Two Formulations of Triptorelin in Chinese Patients with Endometriosis: A Phase 3, Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12 |
98.6; 99.3 | — |
| SECONDARY Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8 |
98.0; 99.3; 97.3; 100.0 | — |
| SECONDARY Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12 |
98.0; 99.3; 95.2; 99.3; 95.9; 98.7 | — |
| SECONDARY Change From Baseline in Endometriosis-associated Pelvic Pain at Weeks 4, 8 and 12 |
-24.4; -24.4; -28.5; -27.8; -28.1; -28.4 | — |
| SECONDARY Mean E2 Concentration at Weeks Baseline and 4, 8 and 12 |
192.302; 218.893; 25.347; 18.959; 47.175; 21.863 | — |
| SECONDARY Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12 |
6.099; 6.258; 1.762; 1.699; 2.891; 2.766 | — |
| SECONDARY Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12 |
3.376; 3.487; 0.660; 0.500; 0.444; 0.255 | — |
| SECONDARY Median Time to Menses Recovery |
179.0; 85.0 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03232281) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.