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临床试验/NCT06230770
NCT06230770进行中(未招募)不适用

The Impact of Progestin-only Contraception on Bleeding Patterns in Individuals Initiating Testosterone Therapy for Gender Affirmation

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年2月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Averbach, MD MAS

Associate Professor

University of California, San Diego

研究点 (1)

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