NCT01183208 - A Safety and Tolerability Study of Administration of PSD502 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

February 28, 2010

Study Completion Date

February 28, 2010

Conditions

Premature Ejaculation

Interventions

DRUG

Intervention A

A single dose of 3 mg will consist of 3 sprays of the 1 mg strength spray applied topically to cervix (1 spray) and vaginal fornices (2 sprays)

DRUG

Intervention B

A single dose of 30 mg will consist of 3 sprays of the 10 mg strength spray applied topically to cervix (1 spray) and vaginal fornices (2 sprays)

DRUG

Intervention C

A single dose of 150 mg will consist of 15 sprays of the 10 mg strength spray applied topically to cervix (5 sprays) and vaginal fornices (10 sprays)

DRUG

Intervention D

A dose of placebo will consist of 3 sprays of the placebo spray applied topically to cervix (1 spray) and vaginal fornices (2 sprays)

DRUG

Intervention E

A dose of placebo will consist of 15 sprays of the placebo spray applied topically to cervix (5 sprays) and vaginal fornices (10 sprays)

Trial Locations (1)

Bio-Kinetic Europe Limited, Belfast