Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomaviru… (NCT03239223) | Clinical Trial Compass
CompletedPhase 1
Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection
United States16 participantsStarted 2018-01-01
Plain-language summary
This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.
Who can participate
Age range25 Years – 50 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL