NCT07201402招募中2 期
Prospective Long-term Study of Etonogestrel Contraceptive Implant Insertion at an Alternative Scapular Site
Yale University3 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2026年5月8日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 3
- 主要终点
- Serum etonogestrel concentrations
研究概览
简要总结
This study aims to evaluate long-term outcomes when the etonogestrel contraceptive implant is inserted at an alternative site located over the scapular. The study will evaluate the pharmacokinetics (i.e., drug levels) and side effect profiles of participants who have an etonogestrel contraceptive implant inserted at this alternative scapular site over the course of at least two years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Sex assigned at birth must be Female
- •Aged 18-45 years
- •In good general health as evidenced by medical history and no need for regular intensive medical interventions (e.g., inpatient admissions, surgical treatments). The Principal Investigator will be responsible for determining good general health for potential participants with complicated medical histories
- •Interest and willingness to use an etonogestrel contraceptive implant
- •Negative pregnancy test at the time of study enrollment and not planning to become pregnant in the next 36 months
- •Willing to abstain from medications and supplements known to induce/inhibit CYP3A (e.g., rifampin, carbamazepine, ketoconazole, St. John's wort) during the study. In the inducer/inhibitor CYP3A medication is a prescribed medication, individuals must provide the prescriber information for the PI to confirm it is safe for this medication to be abstained during the study
- •Body-mass index ≥18.5kg/m2
排除标准
- •Self-reported contraindications to the use of the ENG implant based on the CDC Medical Eligibility Criteria guidelines for any conditions with a category 3 or 4 recommendation
- •Current breast cancer or personal history of breast cancer
- •Malignant liver tumor (hepatocellular carcinoma)
- •Allergic reaction to any components of the ENG implant
- •Any self-reported known liver conditions that could affect drug metabolism (e.g., cirrhosis, hepatitis)
- •Personal history of deep vein thrombosis (DVT), venous thromboembolism (VTE), or arterial thromboembolism (ATE).
- •Currently taking and unable or unwilling to abstain from any medications or supplements known to be CYP3A inducers/inhibitors.
- •Current use of a progestin-only contraceptive method containing desogestrel or etonogestrel
- •History of spinal deformity (e.g., kyphosis, lordosis)
- •History of shoulder or scapular surgery on the non-dominant side
- •Non-dominant shoulder mobility limitations
- •Previous trauma to the non-dominant scapular region
- •Active skin conditions (e.g., psoriasis) in the non-dominant scapular region
- •Inability to palpate the bony landmarks of the scapula due to adiposity or other body habitus
研究组 & 干预措施
Reproductive age females
Experimental
All study participants will be reproductive age females interested in using an etonogestrel contraceptive implant
干预措施: Scapular-site insertion of etonogestrel contraceptive implant (Drug)
结局指标
主要结局
Serum etonogestrel concentrations
时间窗: Every 6 months after insertion of the etonogestrel implant for up to 36 months (3 years)
Serum etonogestrel concentrations measured using a validated LC-MS assay
次要结局
- Progestin-related side effects(Every 6 months after insertion of the etonogestrel contraceptive implant for up to 36 months (3 years))
研究者
Aaron Lazorwitz
Associate Professor of Obstetrics, Gynecology and Reproductive Sciences
Yale University
研究点 (3)
Loading locations...
相似试验
撤回
4 期
Pharmacokinetic Interactions of ENG Subdermal Implants with Long-Acting Cabotegravir (CAB-LA) and LA Rilpivirine (RPV-LA) (CARLA)HIV-1-infectionNCT05156658Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
已完成
4 期
Shoulder Contraceptive Implant StudyContraceptionNCT04463693University of Colorado, Denver5
Unknown
4 期
Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning ScalesPostpartum Depressive MoodPostpartum Sexual FunctionNCT02210702The Jones Institute33
终止
不适用
Acceptability and continued use of the contraceptive implant (Implanon) compared to others contraceptive methods in the Brazilian public sectorContraceptionZ00-Z99RBR-7gqgjmHospital da Mulher Professor Doutor José Aristodemo Pinotti - Centro de Atenção Integral à Saúde da Mulher - CAISM/ Unicamp
已完成
不适用
Acceptability of Long-term Progestin-only Contraception in EuropeContraceptionNCT00931827Bayer436