A Study to Evaluate Topical ABI-1968 Cervical Tissue Penetration in Subjects Prior to Hysterectomy Performed for Benign Indications
- Conditions
- Hysterectomy for Benign IndicationsRenal and Urogenital - Pelvic inflammatory disease
- Registration Number
- ACTRN12619001554156
- Lead Sponsor
- Antiva Bioscience, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 15
1. Women between the ages of 30 and 55 years, who are premenopausal, with an intact uterus.
2. Generally, in good health with no clinically significant pulmonary, cardiac, gastroenterologic,
neurologic, renal, musculoskeletal, rheumatologic, metabolic, neoplastic, or
endocrine disease.
3. Scheduled for a hysterectomy for benign indications (e.g. fibroids, dysfunctional uterine
bleeding, urinary incontinence, pelvic pain etc).
4. Agree to abstain from activities such as sexual intercourse, vaginal douching or insertion of
any vaginal products other than the study drug for at least 48 hours after each dose and to
minimize partner exposure to Topical ABI-1968 Gel during study participation.
5. Able and willing to return to the clinic for all study procedures.
6. Able and willing to provide informed consent.
1. Women who are pregnant
2. Women who are post-menopausal
3. History of cancer, except basal cell or squamous cell carcinoma of the skin.
4. Have a diagnosis of a gynecological cancer or suspicion of cancer that leads to the
hysterectomy
5. History of abnormal cervical cytology within the past 12 months
6. History of excisional (e.g. LEEP, LLETZ) or ablative (e.g. cryo- or electrocautery, laser)
treatment to the cervix
7. History of genital herpes with greater than 3 outbreaks per year, or active non-HPV vaginal infection.
8. Have an active pelvic infection (positive urine screen for gonorrhea or chlamydial infection,
positive bedside testing criteria for bacterial vaginosis, candida vaginitis or trichomonal
vaginitis, positive bimanual exam consistent with pelvic inflammatory disease).
9. Any clinically significant immune suppressing condition.
10. Participants with a significant acute condition or any other condition that in the opinion of the
Investigator might interfere with the evaluation of the study objectives.
11. Currently taking any of the following medications: over the counter (OTC) intra-vaginal
preparation, or any prescription that in the opinion of the Investigator could interfere with the
interpretation of the results, within 2 weeks of enrollment.
12. Hypersensitivity to any component of other nucleoside analogues (such as cidofovir, etc.).
13. Participation in any clinical study with an experimental medication or device within 30 days
or 5 half-lives (whichever is longer) of enrollment.
14. Menses expected to start within 7 days of enrollment.
15. Current alcohol or substance abuse as assessed by the Principal Investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess cervical tissue penetration of ABI-1968 using up to two in vitro technologies after<br>multiple weekly doses of Topical ABI-1968 Gel intravaginally.<br>Outcome Assessment: The presence of ABI-1968 and/or its metabolites in cervical tissue as measured by using the MALDI MS imaging and/or LC/MS assay[MALDI MS imaging and/or LC/MS assay will be performed throughout study.<br>Assessed on biopsy sample sent to lab post hysterectomy]
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of Topical ABI-1968 Gel, when administered to subjects who will undergo hysterectomy for benign indications.<br>Outcome Assessment: Adverse events reported by the participants after ABI-1968 administration<br>Outcome is being assessed by adverse event monitoring and pelvic exam [Safety and tolerability will be performed throughout study.]