The Impact of Progestin-only Contraception on Bleeding Patterns in Individuals Initiating Testosterone Therapy for Gender Affirmation
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Mean days bleeding or spotting
研究概览
简要总结
Gender diverse individuals who use gender-affirming testosterone therapy (GATT) to reduce gender dysphoria may also use progestins for contraception and to manage or suppress uterine bleeding. Research is limited, however, regarding expected bleeding patterns for individuals who choose to initiate GATT concurrently with a progestin. Clinicians who prescribe GATT do not have sufficient data to adequately counsel patients on side effects of concurrent progestin use and therefore extrapolate from studies conducted in cisgender women. This study is a prospective cohort study evaluating bleeding patterns and satisfaction among patients initiating GATT with or without concurrent initiation of a progestin contraceptive. The results from this study will enable clinicians to more accurately counsel patients using GATT on how the use of a progestin might affect their bleeding and whether this differs by progestin method.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English-speaking currently have a uterus and ovaries
- •desire to initiate GATT
- •potential desire to initiate a progestin (within 14 days of GATT initiation)
排除标准
- •previous gender-affirming surgery to remove their uterus and/or ovaries
结局指标
主要结局
Mean days bleeding or spotting
时间窗: Start of GATT to 30 days
mean number of days of bleeding or spotting during the 30 days after GATT initiation
次要结局
未报告次要终点
研究者
Sarah Averbach, MD MAS
Associate Professor
University of California, San Diego
