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 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT01403792
Eligibility Criteria:
Inclusion Criteria:
* A female adult subject aged between 18 and 50 years old.
* They are in good health as determined by medical history, physical examination and clinical judgement before entering into the study.
* Subjects must agree to abstain from vaginal sexual intercourse for 72 hours before and after dosing.
* Subject must agree not to undertake any vaginal practices during study participation other than receptive intercourse with a male, or use of sanitary tampons during menses. Use of condoms without spermicidal agents is encouraged.
* Confirmation from the subject's GP that there is nothing in the subject's medical history that would prevent the subject from participating in the study.
Exclusion Criteria:
* They have a known or suspected ongoing vaginal disease, malignancy or abnormality (including non-menstrual vaginal discharge) discovered at time of screening.
* They have an abnormality, or non-menstrual discharge noted at screening colposcopy.
* They present in the samples obtained at the screening visit:
1. positive results for HIV 1 or 2 antibody.
2. positive results for Hepatitis B sAg, anti-Hepatitis C antibody
3. positive syphilis serology
4. positive test for Neisseria gonorrhoea or Chlamydia trachomatis on urine or urethral swab sample
5. abnormal cervical smear cytology
* A clinically significant amount of protein or haemoglobin in the urine sample, determined by urine dipstick.
* They have received any form of immunosuppressive or immunomodulatory (e.g. vaccines) therapy in the past 6 months.
* They are receiving any medications via vaginal route.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01403792
Study Brief:
Protocol Section:
NCT01403792