Canadian Men's
Clinic
Treating
erectile dysfunction,
premature ejaculation, low libido,
and offering
no-scalpel vasectomy
Toronto • Ottawa • Vancouver
1-888-MEN'S DR'S
1 - 8 8 8 - 6 3 6 - 7 3 7 7
| Information About a Clinical Study on Premature Ejaculation |
Note: After reading the information below, please complete the qualifying questionnaire so we can help you determine if this study is right for you and if you qualify.
Dear Patient,
We are currently conducting a clinical study on premature ejaculation (PE). This study involves the use of an investigational medication for PE that is in the form of a “spray”. The study involves 5 office visits (approximately once per month), with the option to continue in the study for an additional period of time after the first 5 visits.
We are looking for patients that meet the following requirements:
- Men who are in a stable, monogamous relationship for 3 months or more
- Men who are 18 years of age or older
- Men who have premature ejaculation, but who do not have trouble getting an erection
- Men who have a female partner who is willing to participate in this study
Because this study requires your female partner to participate at home, we do require that BOTH you and your partner sign a consent form and undergo blood testing. This means that your partner will only need to attend the first visit. All other visits are attended by you alone.
The study will include the following:
- Detailed blood work including HIV testing
- ECG (echocardiogram)
- Vital signs (blood pressure and heart rate monitoring)
- Physical exam
- Full medical history
- Questionnaires regarding your sexual function
- Stop watch timing (done at home)
The study medication, office visits and tests are provided at NO COST to you. You will be reimbursed for basic travel and parking expenses
Because this is a “study”, some of the participants will be randomized (by computer) into a control group. These patients will receive a placebo (inactive treatment). The placebo medication is harmless. There is 2 to 1 chance that you will receive the active treatment. However, even if you do receive the inactive treatment (the placebo), you will still be offered the chance to switch to the active treatment after you complete the first phase of the study.
This is a “double blind” study, which means that both you and the doctor (and his staff) will NOT know whether you are taking the real medication or the placebo. Once the first phase of the study is over, the study will continue on an optional basis “unblinded” which means that you WILL be given the real treatment and you will know that it is real.
During the first phase of this study, you are not allowed to use condoms. As such another method of birth control must be used. In the second phase of this study, condoms will be permitted.
If you are interested in participating, please complete the QUALIFYING QUESTIONNAIRE and a study coordinator will contact you, confidentially. Alternatively, you can send an email or leave a voice message (contact information listed below) and submit your full name and telephone number for a return call. During that return phone call, we will review your medical history with you to determine if this study is suitable for you and if you qualify. We will also answer your questions about the study.
Thank you for your interest. We look forward to speaking with you.
Sincerely,
Clinical Research Department
Canadian Men's Clinic
Study Line: 416-733-3324 ext. 212 (voicemail only)
alex@mensclinic.comVersion Dec 31, 2007
Received jan 10, 2008
Approved jan 16, 2008