Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

During childhood, the levels of certain hormones: gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH), follicle-stimulating hormone (FSH), estrogen, and progesterone are very low. However, when puberty starts, GnRH and LH pulses begin to increase, but they initially do so at night only. It is unknown why GnRH and LH pulses increase at night and then decrease during the day (instead of being increased all the time). The purpose of this study is to see how quickly progesterone reduces LH pulses. The study is also meant to find out whether too much testosterone (also a hormone) in the blood causes problems with the ability of progesterone to reduce LH pulses. In this study, the investigators aim to discover whether or not giving 3 small doses of progesterone to pubertal girls will prevent the nighttime increase of LH pulses. From the information gathered in this study, the investigators may be able to learn more about how menstrual cycles are normally established in girls during puberty. Ultimately, if the investigators understand these normal processes, the investigators may be able to better understand abnormalities of puberty.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Virginia
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• Female volunteers in early to mid-puberty (i.e., late Tanner I [estradiol level > 20 pg/mL], Tanner II, or Tanner III)

• Premenarcheal

Exclusion Criteria:

• Pregnancy

• Inability to comprehend what will be done during the study or why it will be done

• Hemoglobin less than 12 g/dl and hematocrit less than 36%

• Persistently abnormal sodium, potassium, or bicarbonate (i.e., confirmed on repeat)

• Persistently elevated creatinine, hepatic transaminases, or alkaline phosphatase (i.e., confirmed on repeat)

• Total bilirubin > 1.5 times upper limit of normal (i.e., confirmed on repeat)

• Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.)

• Untreated hypo- or hyperthyroidism, reflected by persistently abnormal thyroid-stimulating hormone (TSH) values

• Total testosterone > 200 ng/dl

• Basal (follicular) 17-hydroxyprogesterone > 200 ng/ml (in girls without a previous diagnosis of congenital adrenal hyperplasia)

• Dehydroepiandrosterone sulfate (DHEA-S) > 800 mcg/dl

• Elevation of prolactin > 2 times upper limit of normal

• Weight less than 26 kg.