ACTRN12617000778381
Completed
未知
Study assessing the safety and tolerability of an intravaginal ointment containing oleic acid in healthy female volunteers.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Zenith Technology Corporation Limited
- Enrollment
- 9
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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