Status:
COMPLETED
Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection
Lead Sponsor:
Antiva Biosciences
Conditions:
HSIL
HSIL of Cervix
Eligibility:
FEMALE
25-50 years
Phase:
PHASE1
Brief Summary
This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.
Eligibility Criteria
Inclusion
- Women, 25 to 50 years old.
- Cervical HSIL diagnosis made within 2 months of enrollment and confirmed with biopsy with no evidence of invasive cancer in any specimen and must be p16+.
- Able and willing to abstain from sexual intercourse for 48 hours prior to first dose and 2 days after each dose.
- Generally experiencing regular menstrual cycles, unless using long-acting reversible contraception that induces amenorrhea (e.g., Mirena IUD, Norplant).
Exclusion
- Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
- History of cancer, except basal cell or squamous cell carcinoma of the skin.
- History of genital herpes with \> 3 outbreaks per year, or active non-HPV vaginal infection.
- Plan to have excision or ablation of the lesion(s) within 3 months of enrollment.
- History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03239223
Start Date
January 1 2018
End Date
October 30 2018
Last Update
July 10 2019
Active Locations (9)
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1
Research Center
Los Angeles, California, United States, 90036
2
Research Center
Lake Worth, Florida, United States, 33461
3
Research Center
Idaho Falls, Idaho, United States, 83404
4
Research Center
Chapel Hill, North Carolina, United States, 27517