Detail of "146479-72-3"

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Patient experience with follitropin alfa prefilled pen versus previously used injectable gonadotropins for ovulation induction in oligoanovulatory women

All Rights Reserved. Patient experience with follitropin alfa prefilled pen versus previously used injectable gonadotropins for ovulation induction in oligoanovulatory women. Somkuti, Stephen G.; Schertz, Joan C.; Moore, Marva; Ferrande, Lee; Kelly, Eduardo (Gonal-f Prefilled Pen in OI Study 24785 Group; Abington Reproductive Medicine, Abington, PA, USA). Current Medical Research and Opinion, 22(10), 1981-1996 (English) 2006 LibraPharm Ltd. CODEN: CMROCX. ISSN: 0300-7995. DOCUMENT TYPE: Journal CA Section: 1 (Pharmacology) Objective: To evaluate patient satisfaction with the follitropin alfa prefilled pen (Gonal-f RFF Pen), compared with previously used injectable gonadotropins (vial/ampoules and syringe), in women undergoing ovulation induction (OI). Research design and methods: Women aged 18-40 years undergoing OI for oligoanovulatory infertility were enrolled from nine US fertility centers in this prospective, open-label clin. trial. Participants received recombinant follitropin alfa using a prefilled pen. Patient satisfaction was detd. using a pre-treatment questionnaire to assess gonadotropin treatments undertaken within 6 mo of study initiation and an in-treatment questionnaire to assess satisfaction with the prefilled pen. Main outcome measures: The primary endpoint was the proportion of patients who preferred the prefilled pen compared to previous injectable gonadotropin therapies. Efficacy and safety were also assessed. Results: Seventy-three subjects were screened for the study; 62 enrolled, were treated with the follitropin alfa pre-filled pen, and 61 completed the in-treatment questionnaire. Sixty-one of 61 patients who stated a preference preferred the prefilled pen to previous injectable gonadotropin therapies (61/61; 100%; 95% confidence interval: [94.1-100.0%]). One patient did not state a preference. Of these 61 patients, 54 (89%) found that the prefilled pen instructions were easy to understand compared to 17 of 59 (29%) who thought instructions for the conventional syringes were easy to understand. When prepg. their dose, significantly fewer patients contacted their healthcare provider two or more times during the treatment cycle when receiving treatment with the prefilled pen (2/61, 3%) than during the first treatment cycle with prior gonadotropin treatment, 11/59 (19%, p = 0.007). The pen interfered slightly or not at all with patients' normal daily activities in 61 of 61 patients (100%) vs.Several substances like 146479-72-3 may be metioned in this study. 50 of 59 patients (85%) who had this opinion regarding injections during their prior treatment cycles (p = 0.003). All 61 patients who stated a method of injection preference found the prefilled pen less stressful to use than syringes and would recommend the pen to another woman considering gonadotropin treatment. A total of 10/62 (16%) subjects reported 18 treatment-emergent adverse events (AEs). Two cases of ovarian hyperstimulation syndrome occurred post-treatment and one serious AE occurred (post-treatment ectopic pregnancy). Injection site reactions were generally mild to moderate, with mild itching (6 patients, 9.7%) and moderate redness in one patient. Fifteen patients reported mild redness (24.2%). Mild bruising (21.0%), mild pain (33.9%), and mild burning (32.3%) were also reported by patients. Seven patients (11.3%) had moderate pain. Conclusions: In this open-label, non-comparative study, patients undergoing OI preferred administering gonadotropins using the follitropin alfa prefilled pen compared to their prior use of vials/ampoules and a syringe. Patients using the prefilled pen found it less stressful, easier to use and more convenient than a conventional syringe and would recommend the pen to another woman considering gonadotropin treatment. .

Validation of a prediction model for the follicle-stimulating hormone response dose in women with polycystic ovary syndrome

All Rights Reserved. Validation of a prediction model for the follicle-stimulating hormone response dose in women with polycystic ovary syndrome. van Wely, Madelon; Fauser, Bart C. J. M.; Laven, Joop S. E.; Eijkemans, Marinus J.; van der Veen, Fulco (Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Academic Medical Center, University of Amsterdam, Amsterdam, Neth.). Fertility and Sterility, 86(6), 1710-1715 (English) 2006 Elsevier. CODEN: FESTAS. ISSN: 0015-0282. DOCUMENT TYPE: Journal CA Section: 1 (Pharmacology) Section cross-reference(s): 2 Objective: To validate a published model for the prediction of the individual FSH response dose for gonadotropin induction of ovulation in polycystic ovary syndrome (PCOS). Design: Structured, complete, and carefully monitored patient-based data collection to test the external validity of the prediction model. Setting: Twenty-nine hospitals in The Netherlands. Patient(s): Eighty-five clomiphene citrate (CC)-resistant women with PCOS. Intervention(s): Ovulation induction in a chronic low-dose step-up FSH regimen. Main Outcome Measure(s): Predicted individual FSH response dose, defined as follicle growth >10 mm in diam. on ultrasound. Result(s): The model, using the women's body mass index, CC response, initial serum FSH level, and initial serum insulin-to-glucose ratio was studied in the validation sample. Overall, the FSH response dose predicted by the model was higher than the obsd. 146479-72-3 and 50-41-9 which are cas registry numbers of substances are two of reagents here. response dose. The predictive performance of the model was poor, with an R2 of 0.11, and the av. prediction error was 35 IU. Conclusion(s): The external validity of the model predicting the individual FSH response dose was inadequate in women with CC-resistant PCOS undergoing ovulation induction with recombinant FSH in a low-dose step-up regimen. .