Abstract | Purpose: Methods: In a Phase III, multicenter, single-blind, parallel-group study, we enrolled 265 Japanese women aged 20-39 years. The patients were menstruating without apparent ovulation or were amenorrheic (with a positive progestin challenge test), and had failed to conceive with anti- estrogen ovulation-induction therapy. The patients underwent a low-dose step-up regimen using follitropin alfa or urofollitropin with a starting dose of 75 IU. The primary endpoint was the proportion of patients who ovulated (mid-luteal serum progesterone ≥5 ng/mL and/or confirmed clinical pregnancy). Secondary endpoints included the proportion of patients with a dominant follicle (≥18 mm) and the duration of stimulation. Results: Ovulation occurred in 79.1% and 82.6% of the patients who received follitropin alfa and urofollitropin, respectively, in the full-analysis set (n = 261), and in 79.2% and 82.5% of the per-protocol set (n = 251). The predefined noninferiority criteria for the primary endpoint were achieved. No significant differences were observed in any secondary endpoint. Treatment-emergent adverse events were reported by a similar proportion of patients in each group ( follitropin alfa, 53.5%; urofollitropin, 50.0%). Conclusions: No significant difference in the primary efficacy endpoint (rate of ovulation) was observed between follitropin alfa and purified urofollitropin in women with anovulatory infertility who were menstruating or had progestin-positive amenorrhea. The use of treatment holidays in this study prevents comparison of the data with previous trials that utilized consecutive daily doses.
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Authors | Yuji Taketani, Eduardo Kelly, Yasunori Yoshimura, Hiroshi Hoshiai, Minoru Irahara, Hideki Mizunuma, Hidekazu Saito, Kazumichi Andoh, Takumi Yanaihara |
Journal | Reproductive medicine and biology
(Reprod Med Biol)
Vol. 9
Issue 2
Pg. 99-106
(06 2010)
ISSN: 1445-5781 [Print] Japan |
PMID | 29699333
(Publication Type: Journal Article)
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