Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1%

PHASE1WithdrawnINTERVENTIONAL
0
Timeline

Start Date

July 31, 2017

Primary Completion Date

December 31, 2017

Study Completion Date

May 31, 2018

Conditions
Post-menopausal Period
Interventions
DRUG

Testosterone gel 1% 2.2 mg

Application of 220 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.

DRUG

Testosterone gel 1% 4.4 mg

Application of 440 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.

DRUG

Testosterone gel 1% 8.8 mg

Application of 880 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.

DRUG

Placebo of Testosterone Gel 1%

Application of approximately 550 mg of Placebo of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.

Sponsors
All Listed Sponsors
lead

Biolab Sanus Farmaceutica

INDUSTRY