Suppression of Daytime and Nighttime LH Frequency by Progesterone in Early Pubertal Girls With and Without Hyperandrogenemia (JCM024)

Who is this study for? Patients with Hyperandrogenism, Polycystic Ovary Syndrome
What treatments are being studied? Progesterone
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 7
Maximum Age: 14
Healthy Volunteers: t
View:

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

• Premenarcheal

Locations
United States
Virginia
Center for Research in Reproduction, University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Melissa Gilrain
pcos@virginia.edu
434-243-6911
Backup
Christopher R McCartney, MD
pcos@virginia.edu
434-243-6911
Time Frame
Start Date: 2011-03-11
Estimated Completion Date: 2024-12
Participants
Target number of participants: 40
Treatments
Experimental: Progesterone
Subjects will take 5-25 mg oral micronized P (based on body weight, to achieve mean plasma P 1-2 ng/ml)
Placebo_comparator: placebo
placebo at 1100, 1500, and 1900 h.
Sponsors
Leads: University of Virginia
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov