This is a Phase I, open-label, parallel trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of Testosterone gel 1% for topic usage in post-menopausal women, for 28 days
This is a Phase I, open-label, parallel trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of Testosterone gel 1% for topic usage in post-menopausal women, Study participants will receive investigational product for 28 consecutive days, once daily, as per the following allocation: 2.2 mg, 4.4 mg. 8.8 mg or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Application of 220 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.
Application of 440 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.
Application of 880 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.
Pharmacokinetics, area under the curve (AUC)
Time frame: 28 days
Pharmacokinetics, maximum concentration (Cmax)
Time frame: 28 days
Pharmacokinetics, time to maximum concentration (Tmax)
Time frame: 28 days
Pharmacokinetics, half-life (t1/2)
Time frame: 28 days
Pharmacodynamics, response rate, by Female Sexual Function Index
Time frame: 28 days
Safety, number of adverse events
Time frame: 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Application of approximately 550 mg of Placebo of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.