Assessment of Two Formulations of Triptorelin in Chinese Patients with Endometriosis: A Phase 3, Randomized Controlled Trial.

INTRODUCTION: This phase 3, randomized, open-label, active-controlled, multicenter study investigated the efficacy of triptorelin pamoate prolonged-release (PR) 3-month in Chinese patients with endometriosis by demonstrating the noninferiority of the 3-month formulation to the standard of care, triptorelin acetate PR 1-month. METHODS: The trial was conducted in 24 clinical centers in China, and included 300 Chinese women (18-45 years) with endometriosis and regular menstrual cycles who required treatment with a gonadotropin-releasing hormone agonist for 6 months. One group of patients (n = 150) was treated with triptorelin pamoate PR 3-month (15 mg per injection, once every 12 weeks), and the other (n = 150) with triptorelin acetate PR 1-month (3.75 mg per injection, once every 4 weeks). The primary outcome measure was the proportion of patients with estradiol (E2) concentrations suppressed to castration levels (≤ 184 pmol/L, or 50 pg/mL) after 12 weeks of treatment. RESULTS: Triptorelin pamoate PR 3-month was noninferior to triptorelin acetate PR 1-month for the treatment of endometriosis: over 98% of patients in both groups were chemically castrated at week 12. Both formulations were also equally efficacious in reducing endometriosis-associated pelvic pain, and reducing serum concentrations of E2, luteinizing hormone, and follicle-stimulating hormone over time. No new safety concerns were identified. CONCLUSION: Triptorelin pamoate PR 3-month is a valid alternative to triptorelin acetate PR 1-month for the treatment of Chinese women with endometriosis, with fewer injections and a potentially lower burden of care. TRIAL REGISTRATION: NCT03232281.

[Clinical comparison of transvaginal hysterectomy and laparoscopic hysterectomy].

OBJECTIVE: To compare the clinical characteristics of transvaginal hysterectomy (TVH) and total laparoscopic hysterectomy (TLH). METHOD: Clinical data about 301 cases who received TVH and TLH were collected and the hospital stay days, medical expenses, diagnoses, operation and recovery status were compared between TVH and TLH groups. RESULTS: The ratio of cervical atypical hyperplasia (9.64%), multipara (96.45%) in TVH was higher than that in TLH (2.88%, 89.42%). The ratio of adenoma (29.44%), adnexal disease (4.55%), pelvic endometriosis (4.06%), history of cesarean section (7.11%) in TVH were lower than that in TLH (43.27%, 31.73%, 12.50%, 24.04%). The operation time (76 +/- 28) minutes, bleeding during operation (170 +/- 125) ml, additional operations (5.08%), pelvic adhesion (4.57%), loosening of pelvic adhesion (0.51%), the diameter of the largest myoma or adenoma (49 +/- 17) mm, expenses for operation and hospitalization (1073 +/- 203) yuan in TVH were lower than those in TLH, which were (139 +/- 52) minutes, (206 +/- 153) ml, 36.54%, 41.35%, 17.31%, (57 +/- 22) mm, (1526 +/- 676) yuan respectively. The differences were significant (all P < 0.05). There was no difference of the uterine weight, complication and length of hospitalization duration between the two kinds of operation. CONCLUSIONS: TVH is recommended in cases of few pelvic adhesion, or adnexal disease, cervical disease and of multipara. The uterine weight is not a decisive factor.