Progesterone Suppression of Nocturnal LH Increases in Pubertal Girls

• Status: Completed
• Trial end date: 2009-06-08
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to learn more about how gonadotropin-releasing hormone (GnRH) and luteinizing hormone (LH) pulses are controlled during puberty. In this study, the investigators aim to discover whether or not giving 2 small doses of progesterone to early pubertal girls will prevent the nighttime increase of GnRH and 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 these normal processes can be understood, 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 1 [estradiol level >20 pg/ml], Tanner 2, or Tanner 3)

• Premenarcheal

Exclusion Criteria:

• BMI-for-age > 85th percentile or < 5th percentile

• Pregnancy

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

• Hyperandrogenism (e.g., hirsutism, elevated free testosterone level)

• History of allergy to progesterone (which is extremely rare)

• 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

• Premature adrenarche (i.e., occurring before age 8 y)

• Basal (follicular) 17-hydroxyprogesterone > 200 ng/ml (confirmed on repeat)

• Dehydroepiandrosterone-sulfate (DHEA-S) > age-appropriate upper limit of normal (confirmed on repeat)

• Hyperprolactinemia (confirmed on repeat)

• Weight less than 25 kg