Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT00370357
Eligibility Criteria:
Inclusion Criteria:
* Provision of written informed consent
* Healthy males aged 18 years or older
* HIV negative
* Reports vaginal intercourse in the past 12 months
* Agrees to abstain from vaginal, anal (receptive and insertive) and oral sexual intercourse, and agrees to refrain from masturbation during the 7 days of product use until after the End-of-Treatment (Day 7) study visit
Exclusion Criteria:
* Known or suspected allergy to any component of the study products or similar ingredients in other products
* History of significant drug reaction or allergy
* Recent history (within 12 months) or presence at screening of contact dermatitis or other dermatological condition
* Recent history (within three months of Screening) of a sexually transmitted infection (STI)
* Current signs or symptoms of UTI and/or STI at Screening or Baseline
* Positive urine leukocyte esterase test (≥ trace)
* Biochemical and/or haematological parameters outside the laboratory's normal reference ranges at Screening
* Evidence of genital piercing, ulceration, genital dermatoses, tinea cruris or other dermatological condition of the genitalia or upper thighs
* Genital pain or discomfort at Screening or Baseline
* Any other abnormal finding on physical examination or other medical condition
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00370357
Study Brief:
Protocol Section:
NCT00370357