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

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.

Timeline

Start

2017-07-28

Primary completion

2019-05-17

Completion

2019-11-16

Publications

• Li X, Li H, Shi H, Li X, Zhou R, Lu D, Cai Y, Zhou Y, Cabri P, Shi X, Pedret-Dunn A, Leng J. Assessment of Two Formulations of Triptorelin in Chinese Patients with Endometriosis: A Phase 3, Randomized Controlled Trial. Adv Ther. 2022 Oct;39(10):4663-4677. doi: 10.1007/s12325-022-02264-5. Epub 2022 Aug 10.

Drugs

Indications