Study Population & Screening
All participants in the trial were to meet the Inclusion Criteria listed below.
- A Telephone Screener document was prepared and can be found in Appendix 1.
Subjects were included in the study if they satisfied the following:
- Males between the ages of 18 and 50 years of age
- In good health, with mild to moderate AGA.
Criteria for Exclusion Prior to the Start of the Study:
- Those that are unemployed as unemployed men do not represent the targeted consumer;
- Those who had been on prescription or over-the-counter use for AGA or a Prostate condition within the past 30 days prior to initiation of the trial;
- Symptomatic cardiac problems, uncontrolled hypertension, symptomatic hypotension, autoimmune disorders;
- Those who had participated in a clinical trial within 30 days prior to Enrollment
- Those with any known allergy to any ingredients in the test products
- Those who are currently taking a MAOI inhibitor
- Those with any other medical condition that could interfere with successful conclusion of the study.
Criteria for Exclusion during the Study
Date of termination of participant in the study will be recorded.
- Grave illness during use. Any subject with a new diagnosis of a grave illness during the study trial will be immediately terminated from the trial. The date of termination from the study will be recorded.
- Sunburn over entire head is reason for exclusion from the study. Subjects will be advised to avoid over exposure to sun during the use period and for at least two (2) weeks afterwards.
All participants in the trial met the Inclusion and Exclusion Criteria listed below. These participants were drawn from specific demographic / psychographic segments based on the following criteria.
Subjects were compensated $25per weekday visit and [$50] for attending any follow-on meetings, focus groups or interviews.
Large Ads were placed in various daily newspapers designed to attract those that suffer from AGA (see Appendix 2 and see Appendix 3).
- 32 participants met the criteria and were invited to participate in the study
- 21 completed the protocol for 90 day study