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Medicine","Webster","77598",{"type":80,"coordinates":400},[401,402],-95.11826,29.53773,{"lat":402,"lon":401},{"type":405,"investigatorFullName":62,"investigatorTitle":62,"investigatorAffiliation":62,"oldNameTitle":62,"oldOrganization":62},"SPONSOR","100117558","phase-2-study-to-assess-the-efficacy-and-safety-of-three-dosage-strengths-of-pulsatile-gnrh-delivered-from-a-iontophoretic-patch-compared-to-oral-treatment-with-clomiphene-or-placebo-in-infertile-females-100117558",false,"NCT00796289","Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Delivered From a Iontophoretic Patch Compared to Oral Treatment With Clomiphene or Placebo in Infertile Females","A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Delivered From a Iontophoretic Patch (Lutrepatch) Compared to Oral Treatment With Clomiphene Citrate or Placebo in Anovulatory or Oligoovulatory Infertile Females","Inclusion Criteria:\n\n1. Females between the ages of 18 and 38 years\n2. Desire to become pregnant\n3. Infertile due to ovulatory dysfunction as described below:\n\n   * Unable to conceive for at least 1 year and\n   * Anovulatory (defined as 4 or fewer menstrual cycles per year) or Oligo-ovulatory (defined as menstrual cycle frequency \\> 45 days)\n\nExclusion Criteria:\n\n1. Requires donor oocytes or sperm\n2. Two or more failed (defined as no biochemical pregnancy achieved) gonadotropin fertility treatment cycles - if previous gonadotropin success, no more than two failed subsequent cycles\n3. Use of insulin-sensitizing drugs (e.g., Metformin) within 1 month prior to progesterone challenge","FEMALE","18 Years","38 Years",{"count":417,"type":418},350,"ACTUAL","INTERVENTIONAL",[421],"PHASE2","The primary objective of this study is to determine the safety and efficacy of pulsatile GnRH delivered from a iontophoretic patch (Lutrepatch) for induction of ovulation in women with anovulatory\u002F oligoovulatory infertility, compared to placebo and to a reference treatment with clomiphene citrate.",[424],"Infertility",[426],"anovulatory\u002Foligoovulatory infertility","COMPLETED","2015-08-26",{"date":430,"type":431},"2015-09-09","ESTIMATED",{"date":433,"type":62},"2009-02",{"date":435,"type":418},"2010-01",{"name":5,"class":6},35]