Progesterone Suppression of Nocturnal LH Increases in Pubertal Girls
Completed · Phase 1 · Has a placebo group
Conditions studied: Female Puberty
In brief
The purpose of this study is to learn more about how gonadotropin-releasing hormone (GnRH) and luteinizing hormone (LH) pulses are controlled during puberty. In this study, the investigators aim to discover whether or not giving 2 small doses of progesterone to early pubertal girls will prevent the nighttime increase of GnRH and 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 these normal processes can be understood, the investigators may be able to better understand abnormalities of puberty.
Key facts
- Study ID
- NCT01773772
- Run by
- University of Virginia
- People needed
- 14
- Starts
- 2005-02-08
- Expected to finish
- 2009-06-08
- Last updated by the study team
- 2020-10-14
Who can join
Age: 9 and older, up to 14. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Female volunteers in early to mid-puberty (i.e. late Tanner 1 [estradiol level >20 pg/ml], Tanner 2, or Tanner 3)
- Premenarcheal
You may not qualify if…
- BMI-for-age > 85th percentile or < 5th percentile
- Pregnancy
- Inability to comprehend what will be done during the study or why it will done
- Hyperandrogenism (e.g., hirsutism, elevated free testosterone level)
- History of allergy to progesterone (which is extremely rare)
- 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
- Premature adrenarche (i.e., occurring before age 8 y)
- Basal (follicular) 17-hydroxyprogesterone > 200 ng/ml (confirmed on repeat)
- Dehydroepiandrosterone-sulfate (DHEA-S) > age-appropriate upper limit of normal (confirmed on repeat)
- Hyperprolactinemia (confirmed on repeat)
- Weight less than 25 kg
Where it is running
- University of Virginia Center for Research in Reproduction — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.