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An Observational Study of Dapoxetine Hydrochloride Tablets applied in Premature Ejaculation Patients

An Observational Study of Dapoxetine Hydrochloride Tablets applied in Premature Ejaculation Patients

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OCH-14005091
Enrollment
Unknown
Registered
2014-08-10
Start date
2014-08-10
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Ejaculation

Interventions

Standard control group:six times sex life within three months, one pill of Dapoxetine Hydrochloride each time 2.5 hours ahead
12 times group:twelve times sex life within three months, one pill of Dapoxetine Hydrochloride each time 2.5 hours ahead
18 times group:eighteen times sex life within three months, one pill of Dapoxetine Hydrochloride each time 2.5 hours ahead
twenty four times group:twenty four times sex life within three months, one pill of Dapoxetine Hydrochloride each time 2.5 hours ahead
thirty times group:thirty times sex life within three months, one pill of Dapoxetine Hydrochloride each time 2.5 hours ahead

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. male, aged 18-64; 2. continuously or repeatedly ejaculating before, during or shortly after insertion in a small stimulus, which is earlier than personal desire. It usually occurs around 1 minute after insertion (primary); or significantly shorter IELT than before, about 3min (secondary); 3. significantly reduced or disappeared ability to control ejaculation; 4. premature ejaculation not by a certain substance (such as alcohol, papaverine and other drugs); 5. negative emotion consequences, such as feeling worried, painful, frustrated, tensed and (or) avoiding close sexual contact; 6. patients in a monogamous sexual relationships with stable sexual life, where at least 6 times of sexual life ensured during the study period (three months); 7. patient accepted and signed for this informed consent.

Exclusion criteria

Exclusion criteria: 1. accompanied with other severe diseases including liver, kidney, cardiovascular disease; 2. accompanied with mental illness or severe neurosis; 3. unable to express the subjective uncomfortableness; 4. there existing contraindications to dapoxetine hydrochloride tablets, such as being allergic to dapoxetine hydrochloride or any excipients; patients with significant heart pathological conditions; taking monoamine oxidase inhibitors (MAOIs), thioridazine, selective serotonin reuptake inhibitors(SSRIs), 5- serotonin - norepinephrine reuptake inhibitor (SNRI), tricyclic antidepressants (TCA) within 14 days before inclusion etc.; 5. accompanied with other sexual dysfunction such as erectile dysfunction; 6. no fixed sexual partner, and no guarantee of six times or more sexual lives during treatment; 7. ineffective after continuous supplies of three consecutive 30mg pills during screening peroid of time; 8. patients not suitable for dapoxetine hydrochloride treatment; 9. recently participated in other clinical trials.

Design outcomes

Primary

MeasureTime frame
IELT;PEP;PEDT;CGIC;

Countries

China

Contacts

Public ContactXu Gang
drxugang@163.com+86 18121186560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026