Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 in Male Patients With Premature Ejaculation

Dong-A Pharmaceutical

Status and phase: Unknown; Phase 2

Conditions: Premature Ejaculation

Treatments: Drug: Placebo; Drug: DA-8031

Study type: Interventional

Funder types: Industry

Identifiers

NCT01798667

DA8031_PE_II

Details and patient eligibility

About

This study is designed to evaluate the efficacy and safety of DA-8031 and to decide the optimal dose of DA-8031 in male patients with premature ejaculation after oral administration on-demand.

The investigators hypothesized that newly-developed DA-8031 would effect in delaying ejaculation in patients with premature ejaculation (PE).

Design:

Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design

Enrollment: 220 estimated patients

Sex: Male

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male patients aged with premature ejaculation for more than 6 months.
• PEDT score ≥ 11

Exclusion criteria

• IIEF-EF domain ≤ 21
• Serum Creatinine ≥ 2.5 mg/dl
• AST, ALT > 3*Upper limit of normal
• Subjects with hypotension(SBP/DBP<90/50mmHg) or uncontrolled hypertension(SBP/DBP>180/100mmHg)
• Subjects with chronic depression, psychiatric or schizophrenia,
• Subjects with alcohol, drug or substance abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

PO administration

Treatment:

Drug: Placebo

DA-8031 dose 1

Experimental group

Description:

PO administration

Treatment:

Drug: DA-8031

DA-8031 dose 2

Experimental group

Description:

PO administration

Treatment:

Drug: DA-8031

DA-8031 dose 3

Experimental group

Description:

PO administration

Treatment:

Drug: DA-8031