Clinical Trials Resource Center

New Medical Therapies™

Infertility

August 16, 2010

Vyteris issued positive results from a phase II trial evaluating their transdermal pulsatile gonadotropin releasing hormone (GnRH) patch for the treatment of infertility. This multicenter, randomized, double-blind, double-dummy, placebo-controlled study enrolled 350 female subjects between the ages of 18 and 38 years with ovulatory dysfunction. The subjects received one of three dose strengths of the GnRH patch, clomiphene citrate (standard of care) or placebo for a single, 21-day treatment cycle. The trial met its primary endpoint by demonstrating a statistically significant difference in ovulation rates for the GnRH patch versus placebo over the 21-day treatment cycle. In addition, among treatment-compliant patients who had at least one progesterone assessment on or after one week of dosing, the GnRH patch led to ovulation rates similar to oral treatment with the standard of care infertility drug. The most common adverse event was skin irritation at the site of administration.

July 28, 2008

Schering-Plough issued positive preliminary results from a phase III trial of corifollitropin alfa for the treatment of female infertility. This double-blind, randomized study, dubbed ENGAGE, enrolled 1,509 female subjects in North America and Europe. The subjects received either corifollitropin alfa 150 mcg or a daily dose of 200 IU recombinant follicle stimulating hormone (FSH) (follitropin beta), followed by recombinant FSH (maximum 200 IU/day) from stimulation day 8 onward. Starting on stimulation day 5, all subjects were scheduled to receive 0.25mg gonadotropin-releasing hormone (GnRH) antagonist until triggering of final oocyte maturation by a urinary human chorionic gonadotropin (hCG). The primary endpoint, ongoing pregnancy rate assessed at 10 weeks or more after embryo transfer, was reached in the 150 mcg corifollitropin alfa treatment arm (38.9% per started cycle). This was similar to that achieved in subjects receiving 200 IU follitropin beta (38.1% per started cycle). The number of oocytes retrieved, the co-primary endpoint, was within the limits of clinical equivalence, and the estimated difference of +1.2 was in favor of the corifollitropin alfa 150 mcg treatment arm. The incidence of ovarian hyperstimulation syndrome was similar between both groups, 7.0% in the corifollitropin alfa group (1.9% severe) and 6.3% in the follitropin beta group (1.3% severe). Further results are expected shortly.

August 21, 2006

Ferring Pharmaceuticals announced positive results from two phase I trials of Actyve transdermal patch, which delivers a peptide through pulses, for the treatment of infertility. The first trial enrolled 45 healthy women who received the peptide at various dose levels using the Actyve patch, subcutaneous injections or intravenous injections, delivered in multiple daily doses for up to 21 days during the 28-day cycle. Plasma concentrations of the subjects indicated Actyve as a potential way to deliver the peptide. The second study enrolled 50 healthy women who received the peptide in various doses via the Actyve patch or subcutaneous delivery, for the same treatment cycle. Plasma profiles indicated that those receiving the peptide via the patch achieved potentially therapeutic levels and provided sharper profiles than the subcutaneous delivery. No unexpected adverse events occurred in either trial. Ferring planned to commence phase II trials in the near term.

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