A Clinical Study to check the Effect and Safety of Tadalafil plus Dapoxetine Tablets for the treatment of co-existing Erectile Dysfunction and Premature Ejaculation.

A Phase-III, Multicentric, Randomized, Double Blind, Placebo-Controlled, Comparative Clinical Study to Evaluate the Efficacy and Safety of Tadalafil 10 mg plus Dapoxetine 30 mg Tablets, Tadalafil 20 mg plus Dapoxetine 30 mg Tablets and Tadalafil 20 mg plus Dapoxetine 60 mg Tablets in the treatment of subjects with co-existing Erectile Dysfunction and Premature Ejaculation.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/05/013767

Enrollment

340

Registered

2018-05-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Co-existing Erectile Dysfunction and Premature Ejaculation. Health Condition 2: N528- Other male erectile dysfunction

Interventions

Intervention1: Tadalafil 10 mg plus Dapoxetine 30 mg Tablets Tadalafil 20 mg plus Dapoxetine 30 mg Tablets Tadalafil 20 mg plus Dapoxetine 60 mg Tablets: One Tablet taken orally with water, on demand,

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects with known case of co-existing Erectile Dysfunction and Premature Ejaculation who are not on any of the treatment for this condition for last 7 days. 2.Male subjects with stable, monogamous, heterosexual relationship for at least 6 months and expected/planned to maintain this relationship for duration of study. 3.Penile Doppler standard systolic and diastolic velocity range for inclusions ( 4.Subjects meeting with diagnostic criteria for erectile dysfunction (as per the international index of erectile function (IIEF) score lesser than or equal to 21). 5.Subjects meeting with diagnostic criteria for Premature Ejaculation (PE score greater than or equal to 11). 6.Subjects with intravaginal ejaculation latency time (IELT) of 7.Subject and his partner agreeing to attempt sexual intercourse at least 2 times/week. 8.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.

Exclusion criteria

Exclusion criteria: 1.Subjects with known case of events or other conditions associated with premature ejaculation/erectile dysfunction including spinal trauma, pelvic surgery. 2.Subjects with known case of genital anatomical deformities and penile deformities. 3.Subjects with known case of penile implant. 4.Sexual dysfunction in female partner, painful intercourse, partners with decreased interest in intercourse. 5.Subjects with abnormal Liver Function Test (LFT) with values more than 2.5 times the upper limit of normal. 6.Subjects with abnormal eGFR ( 7.Subjects with known case of Type 1 Diabetes will be excluded from the study. 8.Subjects with Type 2 Diabetes Mellitus whose diabetes has not been stable and uncontrolled for the previous three months and with HbA1C value greater than 8 % will be excluded from the study.

Design outcomes

Primary

Measure	Time frame
Improvement in IIEF-5 (International Index of Erectile Function Questionnaire) score at week 12 compared to baseline. The change in Intra-vaginal Ejaculation Latency Time (IELT) at week 12 compared to baseline.Timepoint: At the end of 12 weeks	—

Secondary

Measure	Time frame
The change in Premature Ejaculation response measured by Premature Ejaculation Profile (PEP) at week 12 compared to baseline.Timepoint: At the end of 12 weeks	—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd

shailesh.singh@ajantapharma.com0226062111

Outcome results

None listed

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