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Recombinant LH (lutropin alfa) for the treatment of hypogonadotrophic women with profound LH deficiency: a randomized, double‐blind, placebo‐controlled, proof‐of‐efficacy study
Author(s) -
Shoham Z.,
Smith H.,
Yeko T.,
O’Brien F.,
Hemsey G.,
O'Dea L.
Publication year - 2008
Publication title -
clinical endocrinology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.055
H-Index - 147
eISSN - 1365-2265
pISSN - 0300-0664
DOI - 10.1111/j.1365-2265.2008.03299.x
Subject(s) - placebo , medicine , follicular phase , concomitant , hypogonadotrophic hypogonadism , endocrinology , follicle stimulating hormone , luteinizing hormone , hormone , alternative medicine , pathology
Summary Objective To confirm the safety and efficacy of 75 IU lutropin alfa with concomitant follitropin alfa in inducing follicular development in women with profound gonadotrophin deficiency. Design Double‐blind, randomized, placebo‐controlled trial conducted in 25 medical centres in four countries. Patients Thirty‐nine patients with LH < 1·2 IU/l and FSH < 5·0 IU/l were treated with concomitant 75 IU lutropin alfa and 150 IU follitropin alfa or concomitant placebo and 150 IU follitropin alfa. Measurements Primary efficacy end‐point (intent‐to‐treat): follicular development defined by (i) at least one follicle ≥ 17 mm; (ii) serum E 2 level ≥ 400 pmol/l on day of hCG administration (DhCG); and (iii) mid‐luteal phase progesterone level ≥ 25 nmol/l. Results In the analysis of evaluable patients, 66·7% (16 of 24) of patients given lutropin alfa achieved follicular development compared with 20·0% (2 of 10) of patients receiving placebo ( P = 0·023). In the intent‐to‐treat analysis, follicular development was achieved in 65·4% (17 of 26) of patients receiving lutropin alfa and 15·4% (2 of 13) of patients receiving placebo ( P = 0·006). The statistical difference between treatment groups was preserved when over‐response leading to cycle cancellation was analysed as a failed response ( P = 0·034). Lutropin alfa was well tolerated. Conclusion Subcutaneous co‐administration of 75 IU lutropin alfa with follitropin alfa is safe and effective in inducing follicular development in women with profound gonadotrophin deficiency.