A Study to Evaluate Topical ABI-1968 Cervical Tissue Penetration in Subjects Prior to Hysterectomy Performed for Benign Indications

The study is designed to assess cervical tissue penetration of Topical ABI-1968 Gel after multiple weekly dosing in participants with and without cervical cap. Participants who are scheduled to undergo hysterectomy for benign indication in approximately 4 weeks will be enrolled. Up to 12 participants may be enrolled into one of four groups (3 participants per group). Topical ABI-1968 Gel will be administered intra-vaginally by the Investigator or designee after visualizing the cervix in the dorsal lithotomy position. A single-use graduated applicator will be provided for administration of an approximately 2 g dose at a strength up to1%. Eligible participants will receive study gel once weekly up to 4 doses administered by the clinician or designee in the clinic prior to the participant’s planned hysterectomy. One of two methods of delivery of the study gel to the cervix may be used: 1) Just 1% gel gel applied by the clinician directly to the cervix after visualization or 2) Just 1% gel gel Topical ABI-1968 Gel applied into the dome of a cervical cap or diaphragm and inserted blindly into the vagina by the clinician to cover the cervix. Duration of treatment: Once weekly dosing up to a 4-week treatment period. Based on safety data from an ongoing study it has been decided that all groups in Study ABI-1968-104 will receive 1.0% Topical ABI-1968 Gel for each dose. Participants will be assigned to a dosing group by the Sponsor after a consultation with the Investigator. Exact number of doses is determined in each participant by Four weekly dosing in groups 1 and 2 and up to 4 in group 3. Group 3 is for participants whose hysterectomy is scheduled such that they are unable to fit in a total of 4 weekly doses. Group 1: Four weekly dosing of up to 1% of Topical ABI-1968 Gel with cervical cap • Group 2: Four weekly dosing of up to 1% of Topical ABI-1968 Gel without cervical cap • Group 3: Up to 4 weekly dosing up to 1% of Topical ABI-1968 Gel (with or without cervical cap) • Optional Group 4: Repeat the same dosing regimen used in previous groups or test a different regimen (but not to exceed a dose up to 1% Topical ABI-1968 Gel and no more than four weekly dosing). • Group 5: Up to 4 weekly dosing just 1% gel of topical ABI-cream with a cervical cap. Group 4 was incorporated to allow Sponsor to add additional participants should there be a need to further explore any finding from one of the other groups. Sponsor will review initial results and then consult with PIs as to whether there is a need to explore any group further Treatment will be the same as one of the existing 3 groups. Which ever needs further investigation.