ACTRN12619001554156招募中1 期
A study to evaluate topical ABI-1968 cervical tissue penetration after multiple weekly topical ABI-1968 administration intravaginally in subjects prior to hysterectomy performed for benign indications.
Antiva Bioscience, Inc.0 个研究点目标入组 15 人开始时间: 2019年11月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 30 Years 至 55 Years（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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.
研究者
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