Study to Assess Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism

Who is this study for? Patients with Hyperandrogenism
What treatments are being studied? Micronized Progesterone Suspension
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

The purpose of this study is two-fold. (1) We will determine if in mid- to late pubertal girls without hyperandrogenism (HA), progesterone (P4) acutely reduces waking luteinizing hormone (LH) frequency to a greater extent than sleep-associated LH frequency. (2) We will determine if in mid- to late pubertal girls with HA, P4 will acutely suppress waking LH frequency to a lesser degree than it does in girls without HA.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 10
Maximum Age: 17
Healthy Volunteers: t
View:

• Mid- to late pubertal adolescent girl (at least Tanner breast stage 3, but no more than 2 years postmenarcheal)

• For girls without hyperandrogenism: serum (calculated) free testosterone concentration within the Tanner stage-specific reference range and the absence of hirsutism

• For girls with hyperandrogenism: serum (calculated) free testosterone concentration greater than the Tanner stage-specific reference range and/or unequivocal evidence for hirsutism

• General good health (excepting overweight, obesity, hyperandrogenism, and adequately-treated hypothyroidism)

• Capable of and willing to provide informed assent (adolescents under age 16 years) and/or consent (adolescents over age 16 years; custodial parents or guardians of all adolescent volunteers)

• Willing to strictly avoid pregnancy with use of reliable non-hormonal methods during the study period

Locations
United States
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Melissa Gilrain
pcos@virginia.edu
434-243-6911
Time Frame
Start Date: 2008-06
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 36
Treatments
Experimental: Micronized progesterone suspension
Micronized progesterone 0.8 mg/kg at 0700, 1500, 2300 and 0700 h. Progesterone is a natural hormone.
Placebo_comparator: Placebo
Placebo contains only inert ingredients and is not expected to exert any direct physiological effects.
Authors
Christopher R McCartney
Sponsors
Leads: University of Virginia
Collaborators: National Institutes of Health (NIH)

This content was sourced from clinicaltrials.gov

Similar Clinical Trials