Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection

About this trial

Last updated 7 years ago

Study ID

ABI-1968-102

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

Accepting

25 to 50 Years

Female

Trial Timing

Ended 8 years ago

What is this trial about?

This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.

What are the participation requirements?

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.