Clinical Trial: Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Suppression of Daytime and Nighttime LH Frequency by Progesterone in Early Pubertal Girls With and Without Hyperandrogenemia (JCM024)
Brief 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.
Detailed Summary:
Studies will be performed in early pubertal (late Tanner 1 [estradiol level > 20 pg/ml] to Tanner 3, premenarcheal) girls with and without hyperandrogenemia (HA). After a potential subject is identified by the Pediatric, Teen, or Endocrine clinics, she will come to the CRU or alternate UVA clinical unit for an outpatient screening exam. The goals and procedures of the study will be explained to the potential subjects and their custodial parents, and they will be given the opportunity to ask questions. A subject and her custodial parent(s) will be asked to sign the assent and consent forms. A physician will record a family and personal medical history and perform a physical exam. The physical exam will include height, weight, and determination of pubertal stage (Tanner scale). Since adiposity is a potential confounder in this study, measures of adiposity will be recorded. This will include measurement of waist circumference (using standard technique) to provide an estimate of abdominal adiposity. Hip circumference will also be measured. Additionally, BOD POD® will be used to measure total fat mass, fat free mass, and percent body fat. Blood tests will include CBC, Chem17, prolactin, LH, FSH, E2, P, total testosterone, SHBG, DHEA-S, 17-OHP, TSH, insulin, beta-hCG, and cytoadipokines. Bone age (simple x-ray of left hand and wrist) will be measured.
If safety labs are abnormal during screening (e.g., abnormal liver tests, abnormal TSH), subjects will be asked to return once for repeat (confirmatory) labs to exclude lab error, especially when values are only slightly abnormal. Repeat testing will generally occur within one month of the original screening lab draw. If exclusionary lab values are confirmed on such repeat testing, subjects will be excluded from participation. If the subject has a low hemoglobin (<11.5 g/dL for non-African American subjects; Hemoglobin
Sponsor: University of Virginia
Current Primary Outcome: Average luteinizing hormone (LH) interpulse interval and the total number of LH pulses [ Time Frame: 1100hr to 0700 hr ]
Original Primary Outcome: Average Leuteinizing hormone (LH) interpulse interval and the total number of LH pulses [ Time Frame: 1100hr to 0700 hr ]
Current Secondary Outcome: Hourly hormone measurements during sampling period. [ Time Frame: 1100hr to 0700 hr ]
Original Secondary Outcome: Same as current
Information By: University of Virginia
Dates:
Date Received: August 30, 2011
Date Started: May 2008
Date Completion: December 2018
Last Updated: February 23, 2017
Last Verified: February 2017
