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

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 clinical trial. Participants received recombinant follitropin alfa using a prefilled pen. Patient satisfaction was determined using a pre-treatment questionnaire to assess gonadotropin treatments undertaken within 6 months 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 preparing 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%) versus 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.