Reducing Luteinizing Hormone Levels with Progesterone in Pubertal Girls
Suppression of Daytime and Nighttime LH Frequency by Progesterone in Early Pubertal Girls With and Without Hyperandrogenemia (JCM024)
This study is testing if giving small doses of progesterone to early pubertal girls with high androgen levels can help lower their nighttime hormone spikes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 7 Years to 14 Years |
| Sex | Female |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT01428089 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of progesterone on luteinizing hormone (LH) pulses in early pubertal girls, particularly those with hyperandrogenemia. Participants will receive three small doses of progesterone to determine if it can suppress the nighttime increase of LH pulses. The study involves comprehensive screening, including physical exams and blood tests, to assess hormonal levels and overall health. The goal is to better understand the hormonal changes during puberty and their implications for menstrual cycle establishment.
Who should consider this trial
Good fit: Ideal candidates are female volunteers in early to mid-puberty who are premenarcheal and may have hyperandrogenemia.
Not a fit: Patients who are pregnant, have significant hormonal abnormalities, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of hormonal imbalances in pubertal girls, particularly those with conditions like polycystic ovary syndrome.
How similar studies have performed: While the approach of using progesterone to modulate LH levels is not widely tested, similar hormonal interventions have shown promise in related conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female volunteers in early to mid-puberty (i.e., late Tanner I \[estradiol level \> 20 pg/mL\], Tanner II, or Tanner III) * Premenarcheal Exclusion Criteria: * Pregnancy * Inability to comprehend what will be done during the study or why it will be done * 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 * Total testosterone \> 200 ng/dl * Basal (follicular) 17-hydroxyprogesterone \> 200 ng/ml (in girls without a previous diagnosis of congenital adrenal hyperplasia) * Dehydroepiandrosterone sulfate (DHEA-S) \> 800 mcg/dl * Elevation of prolactin \> 2 times upper limit of normal * Weight less than 26 kg.
Where this trial is running
Charlottesville, Virginia
- Center for Research in Reproduction, University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Christopher R McCartney, MD — University of Virginia
- Study coordinator: Melissa Gilrain
- Email: pcos@virginia.edu
- Phone: 434-243-6911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.