Assessment of the Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition

• Status: Active, not recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

Girls with high levels of the male hormone testosterone often develop polycystic ovary syndrome (PCOS) as adults. Women with PCOS often have irregular menstrual periods, excess facial and body hair, and weight gain. Women with PCOS also have difficulty becoming pregnant. Some, girls with high levels of male hormone will develop normal hormone levels as they grow up. Most girls continue to have high levels of male hormone as adults. In addition, girls with elevated levels of male hormones often have lower fertility rates in adulthood. In this study the investigators will aim to discover the effect of 7 days of estrogen and progesterone on GnRH pulses in girls and women with the goal of understanding how and why some girls and women have higher levels of male hormone and the causes of PCOS. If investigators understand the causes of these disorders, they may be able to better treat them and perhaps even learn how to prevent the development of PCOS.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Polyestradiol phosphate; Progesterone

Criteria

Inclusion Criteria:

• Girls ages 8 to 18

• Hyperandrogenemic (testosterone level > 0.4 ng/mL and/or hirsutism)

• Normal screening labs (with exception of the expected hormonal abnormalities inherent in hyperandrogenemia)

Exclusion Criteria:

• Abnormal screening labs (with exception of the expected hormonal abnormalities inherent in hyperandrogenemia)

• Congenital adrenal hyperplasia.

• Hemoglobin <12 mg/dL or hematocrit < 36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit.)

• Weight < 31 kg

• History of peanut allergy, deep venous thrombosis, breast cancer, endometrial cancer, or cervical cancer

• On hormonal medications (including oral contraceptive pills) or on medications known to affect the reproductive axis within 3 months of the study

• Pregnant or breastfeeding

• Participation in a research study within the past 30 days that involved taking a study drug.

• Participation in a research study that involved taking up to or greater than 473 ml's of blood within the past 60 days.

• Cigarette smoking

• History of surgery that required bedrest within the past 30 days

• Family history of hypercoagulability or unexplained thromboembolic disease (not in setting of bedrest, surgery, or malignancy)