Overview
Botswana Study of UC-781 Vaginal Microbicide
Status:
Withdrawn
Withdrawn
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study will test the safety, side effects, and acceptability of two strengths of UC-781 gel when used by women and men in Botswana for two weeks.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Centers for Disease Control and PreventionCollaborator:
CONRADTreatments:
Anti-Infective Agents
UC-781
Criteria
Inclusion Criteria:- 21-45 years old
- citizen of Botswana
- willing to use condoms for 14 days
- PAP smear (normal, inflammation, ASCUS)
- regular menses or amenorrhea
- lives within 1 hour of a study clinic
- pass comprehension test
- provide written informed consent
Exclusion Criteria:
- genital mucosal disruption at screening
- genital surgery within past 8 weeks
- pregnant within past 8 weeks
- currently breastfeeding
- prior hysterectomy
- plans to move within 2 months
- ALT, AST, total bilirubin, or creatinine Grade 2 or above
- Prothrombin or partial thromboplastin time Grade 2 or above
- In other drug/vaccine safety trial
- Has more than one sexual partner in past month
- Unwilling/unsure they can have sex at least twice weekly for 2 weeks
- Any other condition that investigator believes will interfere with the evaluation of
study objectives