PACTR202312652733486尚未招募4 期
Assessing acceptability of Annovera contraceptive vaginal ring use (compared to other contraceptive method use) among women seeking family planning services
The Population Council Inc NY USA0 个研究点目标入组 400 人开始时间: 2023年12月8日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- Female
入选标准
- •All female participants must meet the following criteria to be eligible for inclusion in the study:
- •a. Ages 18 through 45 years old (inclusive) at screening, verified per site-specific SOPs
- •b. Fluent in spoken Shona (Zimbabwe) or Swahili (Kenya) and/or English
- •c. At risk for pregnancy (post-menarche, no prior sterilization, hysterectomy, oophorectomy, or menopause, per self-report)
- •d. Contraceptive intentions:
- •1. for potential Annovera users, desiring to initiate a new contraceptive method or change from one currently being
- •2. for non-Annovera users, has initiated or changed to OC or DMPA use at enrollment
- •e. At least 12 weeks since last DMPA injection (per review of health record) if ever previously used DMPA
- •f. Sexually active, defined as having had penile-vaginal intercourse with a man within the three months before screening
- •g. Not pregnant at screening or enrollment (per negative pregnancy test)
- •h. Not trying to become pregnant or intending to become pregnant within the next year
- •i. No plans to move away from the study site in next 12 months
- •j. Able and willing to provide informed consent
- •k. Able and willing to provide adequate locator information
- •l. In the opinion of the Site PI or designee, able and willing to comply with the protocol and all study procedures
排除标准
- •a. BMI>29 (per exam at screening)
- •b. Known hypersensitivity to or prior complications with estrogens, progestins, silicone or any of the other components of Annovera
- •c. Not eligible for combined hormonal contraception; this includes an assessment of the following:
- •1. Breastfeeding
- •2. Less than 6 weeks (<=42 days) postpartum
- •3. For women 35 and older, currently smokes cigarettes
- •4. History of deep vein thrombosis or pulmonary embolism
- •5. Prolonged immobilization or anticipating major surgery in the next year
- •6. Thrombogenic valvular or thrombogenic rhythm diseases of the heart
- •7. Inherited or acquired hyper-coagulopathies
- •8. Current or history of cerebrovascular disease, coronary artery disease, or ischemic heart disease
- •9. Uncontrolled hypertension or hypertension with vascular disease (self-report and clinic assessment)
- •10. Systemic lupus erythematosus with positive or unknown antiphospholipid antibodies
- •11. Migraines with aura
- •12. For women over 35 years old, migraines without aura
- •13. Current breast cancer or within 5 years of past breast cancer
- •14. Diabetes for > 20 years and/or with nephropathy, retinopathy or neuropathy
- •15. Symptomatic gall bladder disease
- •16. Liver tumor, acute hepatitis or severe cirrhosis
- •17. Undiagnosed abnormal vaginal bleeding
- •18. Known condition where steroid hormones are contraindicated
- •d. Use of medications that are contraindicated or believed to have a drug-drug interaction with Annovera
- •e. Current abnormal vaginal discharge, genital tract lesions, or active pelvic infections (for woman in whom the clinician suspects a genitourinary tract infection, treatment should be offered and woman can enroll following resolution of symptoms)
- •f. History of genital tract surgery (including cervical polypectomy, dilatation and curettage, hysteroscopy, or laparoscopy) in the three months prior to the screening visit
- •g. History of toxic shock syndrome
- •h. Recurrent vulvovaginal candidiasis (defined as more than 3 episodes in the preceding year)
研究者
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