Exploratory Study of Pagoclone in Men With Premature Ejaculation.

Endo Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Premature Ejaculation

Treatments: Drug: pagoclone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00370981

IP456-040

Details and patient eligibility

About

The purpose of this study is to evaluate pagoclone in the treatment of premature ejaculation.

Full description

The primary objective of this study is to evaluate the effect of 3 dose levels of pagoclone (0.15 mg, 0.30 mg, and 0.60 mg) versus placebo on intravaginal ejaculation latency time (IELT) male patients with primary premature ejaculation.

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• A male regularly experiencing premature ejaculation
• 18 to 55 yrs old
• In a Stable relationship with one woman for at least 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups, including a placebo group

0.15 mg

Experimental group

Treatment:

Drug: pagoclone

0.30 mg

Experimental group

Treatment:

Drug: pagoclone

0.60 mg

Experimental group

Treatment:

Drug: pagoclone

PBO

Placebo Comparator group

Treatment:

Drug: pagoclone