OBJECTIVETo evaluate the efficacy and safety of gonadotropin-releasing hormone analogue (GnRHa) triptorelin 11.25 mg 3-month sustained release formulations in the treatment of metastatic prostate cancer.

METHODSFrom January 2004 to March 2006, a randomized, parallel-controlled, multicenter clinical trial was conducted. One hundred and twenty-seven patients with documented metastatic prostate cancer were randomized to receive one injection of the 11.25 mg formulation triptorelin (n = 65) or three injections at 28-day intervals of the 3.75 mg formulation (n = 62). Changes from baseline of TPSA, prostate volume, testosterone, LH, FSH, PRL and estradiol were assessed over 3 months. Changes of the metastatic lesions were also observed and evaluated. The occurrences of adverse events were evaluated as well.

RESULTSAfter 3 months treatment, total PSA level decreased significantly from baseline both in 11.25 mg group and 3.75 mg group. At 30, 60 and 90 days, TPSA (median level) declined from 164.55 microg/L into 11.34, 4.12, 3.89 microg/L in 11.25 mg group, and from 101.38 microg/L into 6.88, 2.41, 2.57 microg/L in control group respectively. The patients ratio with over 90% decreasing from TPSA baseline were 78.6% and 75.5% respectively in two groups (P = 0.700). Prostate volume were also decreased significantly in both groups, median volume declined from 48.0 mm(3) into 21.5 mm(3) in 11.25 mg group and from 45.0 mm(3) into 21.0 mm(3) in 3.75 mg group. No significant differences were found between the two groups in changes of TPSA (P = 0.601) and prostate volume (P > 0.05). Both formulations were able to induce castration levels, 0.31 microg/L in 11.25 mg group and 0.26 microg/L in 3.75 mg group (P > 0.05). 13.8% and 17.7% of adverse events were recorded respectively in two groups, and no differences were found (P = 0.547).

CONCLUSIONAs a new long-acting sustained release formulation, triptorelin 11.25 mg is comparable to triptorelin 3.75 mg formulation in the aspect of efficacy and safety for the treatments of metastatic prostate cancer.

Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents, Hormonal ; administration & dosage ; therapeutic use ; Gonadotropin-Releasing Hormone ; analogs & derivatives ; therapeutic use ; Humans ; Male ; Middle Aged ; Prostatic Neoplasms ; drug therapy ; pathology ; Safety ; Treatment Outcome ; Triptorelin Pamoate ; administration & dosage ; therapeutic use

OBJECTIVETo study the clinical effects of Shen-nourishing and menstruation-regulating method (SNMRM) combined with Triptorelin Acetate Injection (TAI) on patients with luteinized unruptured follicle syndrome (LUFS).

METHODSSixty-two LUFS patients were randomly assigned to the treatment group and the control group. TAI was given to patients in the control group while SNMRM + TAI was given to those in the treatment group. The ovulation rate and the pregnancy rate were observed in the two groups.

RESULTSThe ovulation rate in the treatment group was higher than that in the control group, but without significant difference (85.53% versus 79.07%, P > 0.05). The pregnancy rate was significantly higher in the treatment group than in the control group (56.25% vs 30.00%, P < 0.05).

CONCLUSIONTreatment of LUFS by SNMRM + TAI could improve the ovulation rate and the pregnancy rate, indicating that LUFS patients' ovary functions could be improved by using different menstruation regulating methods during different follicular development phases.

Adult ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Infertility, Female ; drug therapy ; Menstruation ; drug effects ; Ovarian Diseases ; drug therapy ; Ovarian Follicle ; physiopathology ; Ovulation ; drug effects ; Pregnancy ; Pregnancy Rate ; Triptorelin Pamoate ; therapeutic use ; Young Adult

The effects of pituitary suppression with one-third depot of long-acting gonadotropin-releasing hormone (GnRH) agonist in GnRH agonist long protocol for in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) were investigated. A retrospective cohort study was performed on 3186 cycles undergoing IVF/ICSI with GnRH agonist long protocol in a university-affiliated infertility center. The pituitary was suppressed with depot triptorelin of 1.25 mg or 1.875 mg. There was no significant difference in live birth rate between 1.25 mg triptorelin group and 1.875 mg triptorelin group (41.2% vs. 43.7%). The mean luteinizing hormone (LH) level on follicle-stimulating hormone (FSH) starting day was significantly higher in 1.25 mg triptorelin group. The mean LH level on the day of human chorionic gonadotrophin (hCG) administration was slightly but statistically higher in 1.25 mg triptorelin group. There was no significant difference in the total FSH dose between the two groups. The number of retrieved oocytes was slightly but statistically less in 1.25 mg triptorelin group than in 1.875 mg triptorelin group (12.90±5.82 vs. 13.52±6.97). There was no significant difference in clinical pregnancy rate between the two groups (50.5% vs. 54.5%). It was suggested that one-third depot triptorelin can achieve satisfactory pituitary suppression and produce good live birth rates in a long protocol for IVF/ICSI.
Adult ; Down-Regulation ; Female ; Fertilization in Vitro ; methods ; Follicle Stimulating Hormone ; blood ; Humans ; Live Birth ; Luteinizing Hormone ; blood ; Pituitary Gland ; drug effects ; secretion ; Pregnancy ; Sperm Injections, Intracytoplasmic ; methods ; Triptorelin Pamoate ; administration & dosage ; pharmacology ; therapeutic use

Pulsatile gonadotropin-releasing hormone (GnRH) may induce spermatogenesis in most patients with congenital hypogonadotropic hypogonadism (CHH) by stimulating gonadotropin production, while the predictors for a pituitary response to pulsatile GnRH therapy were rarely investigated. Therefore, the aim of our study is to investigate predictors of the pituitary response to pulsatile GnRH therapy. This retrospective cohort study included 82 CHH patients who received subcutaneous pulsatile GnRH therapy for at least 1 month. Patients were categorized into poor or normal luteinizing hormone (LH) response subgroups according to their LH level (LH <2 IU l^-1 or LH ≥2 IU l^-1) 1 month into pulsatile GnRH therapy. Gonadotropin and testosterone levels, testicular size, and sperm count were compared between the two subgroups before and after GnRH therapy. Among all patients, LH increased from 0.4 ± 0.5 IU l^-1 to 7.5 ± 4.4 IU l^-1 and follicle-stimulating hormone (FSH) increased from 1.1 ± 0.9 IU l^-1 to 8.8 ± 5.3 IU l^-1. A Cox regression analysis showed that basal testosterone level (β = 0.252, P = 0.029) and triptorelin-stimulated FSH_60min(β = 0.518, P = 0.01) were two favorable predictors for pituitary response to GnRH therapy. Nine patients (9/82, 11.0%) with low LH response to GnRH therapy were classified into the poor LH response subgroup. After pulsatile GnRH therapy, total serum testosterone level was 39 ± 28 ng dl^-1 versus 248 ± 158 ng dl^-1 (P = 0.001), and testicular size was 4.0 ± 3.1 ml versus 7.9 ± 4.5 ml (P = 0.005) in the poor and normal LH response subgroups, respectively. It is concluded that higher levels of triptorelin-stimulated FSH_60minand basal total serum testosterone are favorable predictors of pituitary LH response to GnRH therapy.
Adult ; Cohort Studies ; Follicle Stimulating Hormone/blood* ; Gonadotropin-Releasing Hormone/therapeutic use* ; Gonadotropins/blood* ; History, 16th Century ; Humans ; Hypogonadism/pathology* ; Luteinizing Hormone/blood* ; Male ; Pituitary Gland/pathology* ; Predictive Value of Tests ; Retrospective Studies ; Sperm Count ; Testis/pathology* ; Testosterone/blood* ; Treatment Outcome ; Triptorelin Pamoate/therapeutic use* ; Young Adult