Safety and tolerability of a vaginal ointment without any active drugs in healthy women.

Not Applicable

Completed

• Conditions: Cervical neoplasia and condyloma acuminatum; Infection - Sexually transmitted infections

• Registration Number: ACTRN12617000778381
• Lead Sponsor: Zenith Technology Corporation Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-29
• Study Completion: 2017-09-06
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 9

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified