Cecilia McWhirter

• Statistician at PRA Health Sciences

A new formulation of testosterone gel (1.62% testosterone gel) with increased viscosity and reduced volume of application has been shown to be safe and efficacious after 182 days of use in a phase 3, double-blind study in adult hypogonadal males. The objective of this study was to evaluate the efficacy and safety of the 1.62% testosterone gel after...

To evaluate secondary exposure of testosterone transferred to females from a male partner, dosed with 1.62% testosterone gel after direct skin-to-skin contact with the application site, and to investigate the effect of wearing a t-shirt on testosterone transfer. Across three studies, a total of 72 healthy males applied 5.0 g 1.62% testosterone gel...

To evaluate the effect of application site location, clothing barrier, and application site washing on testosterone transfer from males dosed with 1.62% testosterone gel to female partners. Open-label, randomized, parallel group, crossover study performed in 24 healthy male/female couples. 2.5 or 5.0 g of gel was applied to upper arms and shoulders...

The impact of washing on the pharmacokinetics, systemic absorption and residual testosterone on the skin after application of a 1.62% testosterone gel was investigated in an open-label, randomized, three-way crossover study in hypogonadal men. Twenty-four hypogonadal men (total testosterone <300 ng/dL) applied 5 g of 1.62% gel (81 mg testosterone)...

Male hypogonadism is a significant and growing problem that can be successfully treated with testosterone replacement therapy. A new formulation of testosterone gel (1.62%) was developed with increased viscosity, reduced volume of application, and increased skin permeation compared with other currently available testosterone gels. To evaluate the e...

To determine the pharmacokinetics, bioavailability, and safety of a new formulation (1.62%) of testosterone gel that produces eugonadal serum testosterone levels with use of a lower amount of gel than the currently available 1% gels. In an open-label, randomized, 3-way crossover study, 36 male patients with hypogonadism applied 5 g of 1.62% testost...

To determine the prevalence of subnormal testosterone concentrations in patients with obesity and with type 2 diabetes in a primary care clinic population. Free testosterone concentrations of 1,849 men (1,451 nondiabetic and 398 diabetic) in the Hypogonadism In Males (HIM) study were analyzed. The HIM study was a U.S.-based cross-sectional study de...

The Hypogonadism In Males study estimated the prevalence of hypogonadism in men aged > or =45 years. A sub-analysis of patients not receiving testosterone (T) therapy was conducted. Blood draw times were 0800-1000 and 1000-1200 hours. Total T (TT) was not influenced by draw time for any age group; however, significantly greater free T (FT) and bioa...

The Hypogonadism in Males study estimated the prevalence of hypogonadism [total testosterone (TT) < 300 ng/dl] in men aged > or = 45 years visiting primary care practices in the United States. A blood sample was obtained between 8 am and noon and assayed for TT, free testosterone (FT) and bioavailable testosterone (BAT). Common symptoms of hypogona...

Hypogonadism (total testosterone [TT] <300 ng/dL) is associated with signs and symptoms that include erectile dysfunction, bone mineral density loss, and decreased quality of life. The goal of this study was to estimate the prevalence rate of hypogonadism in men presenting to primary care practices, focusing on those with a history of hypertension....

Allergic conjunctivitis can seriously disrupt children's daily activities. This study assessed the efficacy (onset and duration of action) and safety of ketotifen fumarate 0.025% ophthalmic solution compared with vehicle placebo in pediatric subjects after single and multiple dosing. This was a double-masked, multicenter, fellow-eye, placebo-contro...

To compare the efficacy and safety of ketotifen 0.025% ophthalmic solution (one drop/eye) with placebo as adjunctive therapy to mometasone nasal spray (50 microg/spray, two puffs/nostril) in subjects with seasonal allergic rhinoconjunctivitis (SARC). Single-centre, randomised, double-masked, two-treatment, two-period crossover study. 8-hour allerge...

This single-masked, contralateral-eye, active-controlled allergen-challenge study compared ketotifen fumarate .025% and cromolyn sodium 4% ophthalmic solutions in the prevention of ocular itching, tearing, and redness induced by allergen challenge. After a confirmatory conjunctival provocation test (CPT), 56 patients randomly received masked study...