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.
- Conditions
- Health Condition 1: null- Co-existing Erectile Dysfunction and Premature Ejaculation.Health Condition 2: N528- Other male erectile dysfunction
- Registration Number
- CTRI/2018/05/013767
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 ( <25 cm/sec as definite arterial dysfunction and 25-30 cm/sec as borderline case.)
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 <= 2 minutes.
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.
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 ( <60 mL/min/1.73 m2) will be excluded from the study.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method