Assessment of Day-night Secretion of Progesterone and LH Across Puberty
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies, Endocrine |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 7 - 17 |
| Updated: | 4/17/2018 |
| Start Date: | February 2008 |
| End Date: | February 2019 |
| Contact: | Melissa Gilrain |
| Email: | pcos@virginia.edu |
| Phone: | 434-243-6911 |
Assessment of Day-night Secretion of Progesterone and LH Across Pubertal Maturation in Girls With and Without Hyperandrogenemia (JCM023)
Hormones are substances that are made by the body and are sent directly out into the
bloodstream to increase or decrease the function of certain organs, glands, or other
hormones. Testosterone is a hormone found in the blood of all girls, but some girls have too
much testosterone in their blood. Too much testosterone in the blood can possibly lead to a
problem called polycystic ovary syndrome (PCOS). People with PCOS have abnormal menstrual
periods, excess facial and body hair, and too much testosterone in their blood. On the other
hand, some girls with too much testosterone in their blood do not develop PCOS. We do not
know why some of these girls develop PCOS and why some do not. The purpose of this research
study is to find out whether too much testosterone can cause problems with other hormones
that can lead to the development of PCOS. This study may help us understand more about the
causes of PCOS.
bloodstream to increase or decrease the function of certain organs, glands, or other
hormones. Testosterone is a hormone found in the blood of all girls, but some girls have too
much testosterone in their blood. Too much testosterone in the blood can possibly lead to a
problem called polycystic ovary syndrome (PCOS). People with PCOS have abnormal menstrual
periods, excess facial and body hair, and too much testosterone in their blood. On the other
hand, some girls with too much testosterone in their blood do not develop PCOS. We do not
know why some of these girls develop PCOS and why some do not. The purpose of this research
study is to find out whether too much testosterone can cause problems with other hormones
that can lead to the development of PCOS. This study may help us understand more about the
causes of PCOS.
Polycystic ovary syndrome (PCOS) is a common disorder marked by irregular ovulation and
hyperandrogenism. Hyperandrogenemia during adolescence can be a forerunner of adult PCOS.
However, the progression of hormonal abnormalities leading to PCOS are unclear. We will
examine hormonal profiles (e.g., LH, FSH, progesterone, testosterone, estradiol) during
pubertal maturation in adolescent girls with and without elevated plasma androgens. The
working hypothesis is that, in pubertal girls without hyperandrogenemia, overnight rises of
progesterone are associated with a reduction of LH frequency during the waking morning hours.
However, in pubertal girls with hyperandrogenemia, LH frequency will be higher than normal
during both the day and night, despite similar or higher progesterone levels. The studies
will involve frequent blood sampling over 18 hours. We will assess differences in hormone
parameters between time blocks (1900-2300 h, 2300-0300 h, 0300-0700 h, 0700-1100 h) in
individuals to evaluate day-night changes. We will compare such changes between those with
hyperandrogenemia and those without hyperandrogenemia.
hyperandrogenism. Hyperandrogenemia during adolescence can be a forerunner of adult PCOS.
However, the progression of hormonal abnormalities leading to PCOS are unclear. We will
examine hormonal profiles (e.g., LH, FSH, progesterone, testosterone, estradiol) during
pubertal maturation in adolescent girls with and without elevated plasma androgens. The
working hypothesis is that, in pubertal girls without hyperandrogenemia, overnight rises of
progesterone are associated with a reduction of LH frequency during the waking morning hours.
However, in pubertal girls with hyperandrogenemia, LH frequency will be higher than normal
during both the day and night, despite similar or higher progesterone levels. The studies
will involve frequent blood sampling over 18 hours. We will assess differences in hormone
parameters between time blocks (1900-2300 h, 2300-0300 h, 0300-0700 h, 0700-1100 h) in
individuals to evaluate day-night changes. We will compare such changes between those with
hyperandrogenemia and those without hyperandrogenemia.
Inclusion Criteria:
- Early and late pubertal girls with normal androgens
- Early and late pubertal girls with hyperandrogenemia
- All subjects will be girls from pre-puberty (Stage 1 breast development and pubic hair
growth but at least 7 years old) to 7 years post menarche.
Exclusion Criteria:
- Pregnancy
- Inability to comprehend what will be done during the study or why it will be done
- Hemoglobin <11.5 g/dL for non-African American subjects; Hemoglobin < 11.0 g/dL for
African American subjects
- 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 TSH values)
- Total testosterone > 200 ng/dl
- Basal (follicular) 17-OHP > 200 ng/ml (in girls without a previous diagnosis of
congenital adrenal hyperplasia)
- DHEA-S > 800 mcg/dl
- Elevation of prolactin > 2 times upper limit of normal
- Weight less than 25 kg
We found this trial at
1
site
Charlottesville, Virginia 22908
Phone: 434-243-6911
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