Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation

Symyoo

Status and phase: Completed; Phase 2

Conditions: Premature Ejaculation

Treatments: Drug: Clomipramine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01203202

CTC PE 02

Details and patient eligibility

About

The purpose of this study is to evaluate whether PED-1 (15mg) and PED-2 (30mg) are tolerable and effective in the treatment of premature ejaculation.

Full description

This study is to evaluate whether PED-1 and PED2 are tolerable and effective in the treatment of premature ejaculation. The patients will be randomized and allocated to three treatment groups into placebo, PED-1, and PED-2. The creteria for IELT for enrollment will be > or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT will be used. The patients ungone drug free baseline line period will take test drugs for 4 weeks.

Enrollment: 104 patients

Sex: Male

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent for subjects and partdners
• Men 20-65
• stable monogamous relation at least for 6 mn
• PEDT more than 9
• at least 6 Mn of premature ejaculation Hx
• IELT of =< 2 min in >= 75% of evaluable events during 4 week secreening period

Exclusion criteria

• Hx of medical or psychiartric illness
• erectile dysfunction (<21 IIEF EF domain score) or other forms of sexual dysfunction
• Partner sexual dysfunction
• known hypersensitivity to clomipramine and contraindications for clomipramine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 3 patient groups, including a placebo group

PED 0

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Clomipramine

PED 1

Experimental group

Description:

PED-1 (clomipramine 15mg)

Treatment:

Drug: Clomipramine

PED-2

Experimental group

Description:

PED-2 (Clomipramine 30mg)

Treatment:

Drug: Clomipramine