None listed
Conditions
Brief summary
The objective of this study is to evaluate the safety and tolerability of a 21 day treatment of self-administered vaginal ointment vehicle containing oleic acid.
Interventions
A pilot study to investigate the safety and tolerability of a vaginal ointment that does not yet have any active ingredient. The study is being conducted to make sure it is a comfortable ointment to use in the vagina.
The ointment will be self-administered into the vagina, once daily for 21 days and a questionnaire will be used about its effects. Full instructions will be given as to its application. Participants will also be asked to provide a urine sample and vaginal swabs at various in
A pilot study to investigate the safety and tolerability of a vaginal ointment that does not yet have any active ingredient. The study is being conducted to make sure it is a comfortable ointment to use in the vagina. The ointment will be self-administered into the vagina, once daily for 21 days and a questionnaire will be used about its effects. Full instructions will be given as to its application. Participants will also be asked to provide a urine sample and vaginal swabs at various intervals throughout the study. The ointment will be given to participants to take home in pre-filled applicators along with the study questionnaires. A diary will be completed by each participant and each participant will sign upon each administration. Pre and post study laboratory tests will be completed to assess the health of participants along with drugs of abuse testing. The intervention for this study is the ointment formulation of oleic acid.
Sponsors
Zenith Technology Corporation Limited
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy non-pregnant females Aged between 18 and 55 A normal atypical or low grade intraepithelial lesion on cervical smear in the preceding 12 months BMI between 19 and 30 inclusive Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests Able to provide written informed consent and willing to adhere to all study instructions and restrictions.
Exclusion criteria
Concomitant drug therapy for any condition that is not well controlled or that might affect the vaginal mucosa. Sensitivity to the study ointment History of any clinically significant medical conditions Clinically significant abnormality or abnormal laboratory test result found during medical screening Females who are pregnant and/or are breastfeeding History of alcohol or drug abuse or dependency Participation in a drug study within 30 days of the start of the study Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk
Outcome results
None listed