The study sponsor terminated the grant funding.

This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females.

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.

Inclusion Criteria: 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)

Exclusion Criteria: All

• Pregnant
• 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, GnRH antagonists, GnRH agonists, insulinomimetics, and metformin.
• History of prior testosterone therapy

Cisgender females; Transgender males/non-binary/gender non-conforming initiating testosterone replacement therapy

We will not be sharing IPD.

The study terminated before enrollment of TGM initiating TRT. Two CGF participants signed the consent form, but did not provide any demographic information. The only data we collected were name and signature. No data were analyzed. No data will be analyzed in the future. The enrollees would have been scheduled for study visits a week or two after signing the consent form.

There is no time frame because the study sponsor terminated the grant funding before any analyzable data were collected. The study sponsor terminated the grant funding days after the first two participants signed consent forms, but before any data, besides names and signatures on consent forms, were collected. There are no data to analyze. No data will be analyzed in the future.

There was no adverse event collection timeframe because the two enrollees did not have any study visits. The study sponsor terminated the grant funding before any data, besides names and signatures on consent forms, were collected. There are no adverse event data to collect or to analyze.