Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Determination of Pulsatile Luteinizing Hormone (LH) Secretion
研究概览
简要总结
This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females.
详细描述
Testosterone Replacement Therapy (TRT) is the mainstay of gender affirming care for transgender men (TGM) who have male gender identity after female sex assignment at birth. TGM receiving TRT over time exhibit irregular menstrual bleeding, however, the mechanism of menstrual disruption is unknown. Therefore, the investigators propose to evaluate the effect of chronic testosterone (T) exposure on ovarian hormones and pituitary gonadotropin release that determines menstrual cyclicity. The investigators will conduct a detailed study of blood reproductive hormone secretion in TGM before and during TRT as well as in untreated cisgender female (CGF) control subjects who report female gender identity congruent with female sex assignment at birth. The investigators will also perform periodic clinical and ultrasonographic evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Transgender/Non-binary Group, Initiating Testosterone Group
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Aged 18-35
- •Plan to initiate testosterone therapy
- •History of regular menstrual cycles (every 24-35 days) at baseline, before beginning TRT
- •Inclusion Criteria: Cisgender Female Group
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Aged 18-35
- •Having regular menstrual cycles (every 24-35 days)
排除标准
- •Incarcerated
- •Known cognitive impairment or institutionalized
- •Hemoglobin less than 11 gm/dl at screening evaluation
- •Weight less than 110 pounds
- •BMI <18 or >35
- •Current endocrine disease- including untreated thyroid abnormalities, pituitary or adrenal disease, polycystic ovary syndrome, or androgen producing tumor
- •Current or recent pregnancy within two months of study enrollment
- •Current or recent breast feeding within two months of study enrollment
- •Diabetes, or renal, liver, or heart disease
- •History of oophorectomy or hysterectomy
- •History of radiation or surgery involving brain structures and/or pelvis/pelvic organs
- •Currently taking any medications that may affect their reproductive hormones, such as contraceptive medications, androgens, estrogens, progestins, gonadotropin-releasing hormone (GnRH) antagonists, insulinomimetics, and metformin.
- •History of prior testosterone therapy
研究组 & 干预措施
Transgender Men (TGM) initiating Testosterone Replacement Therapy (TRT)
Transgender men/non-binary/non-gender-conforming initiating testosterone replacement therapy
干预措施: Testosterone Cypionate 50 milligrams per millileter (mg/mL) Injectable Solution (Drug)
Cisgender Female (CGF) control group
Cisgender females serving as a control group
结局指标
主要结局
Determination of Pulsatile Luteinizing Hormone (LH) Secretion
时间窗: Through study completion, an average of 7 months.
Subjects will have baseline measurement of serum LH immediately followed by frequent blood sampling at 10-min intervals for 8 h. We will measure LH pulse frequency, the number of LH pulses per 8 hours.
Uterine Bleeding Pattern
时间窗: Through study completion, an average of 7 months.
All subjects will complete a daily uterine bleeding log using REDCap®
Evidence of Luteal Activity (ELA)
时间窗: Through study completion, an average of 7 months.
Evidence of Luteal Activity (ELA), as defined by serum progesterone level above 3 ng/mL in transgender men initiating testosterone replacement therapy.
次要结局
- Evaluate Serum FSH(Through study completion, an average of 7 months.)
- Evaluate Serum AMH(Through study completion, an average of 7 months.)
- Evaluate Serum LH(Through study completion, an average of 7 months.)
- Evaluate Serum Estradiol(Through study completion, an average of 7 months.)
- Evaluate Serum Testosterone(Through study completion, an average of 7 months.)
研究者
Antoni Duleba
Professor
University of California, San Diego