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

Ipsen

Status and phase: Completed; Phase 3

Conditions: Endometriosis

Treatments: Drug: Triptorelin Pamoate PR 3-month; Drug: Triptorelin Acetate PR 1-month

Study type: Interventional

Funder types: Industry

Identifiers

NCT03232281

D-CN-52014-220

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Triptorelin pamoate PR 3-month

Experimental group

Description:

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).

Treatment:

Drug: Triptorelin Pamoate PR 3-month

Triptorelin acetate PR 1-month

Active Comparator group

Description:

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).

Treatment:

Drug: Triptorelin Acetate PR 1-month