Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Ovarian Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 8 - 14 |
| Updated: | 3/3/2019 |
| Start Date: | January 27, 2009 |
| End Date: | January 2020 |
Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition in Early Pubertal Girls (JCM026)
Gonadotropin-releasing hormone (GnRH) is a hormone that regulates the ability of the
pituitary to secrete two hormones, luteinizing hormone (LH) and follicle-stimulating hormone
(FSH). LH and FSH control the production of female hormones (such as estrogen and
progesterone) and the development of eggs by the ovary. Progesterone and estrogen then
decrease the number of GnRH pulses produced by the brain (and therefore the number of LH
pulses from the pituitary). The ability to decrease GnRH pulses seems to be very important
for normal menstrual function in adult women. The purpose of this study is to learn more
about how GnRH and LH pulses are controlled during puberty. The information gathered in this
study will hopefully allow us to learn more about how menstrual cycles are normally
established in girls during puberty.
pituitary to secrete two hormones, luteinizing hormone (LH) and follicle-stimulating hormone
(FSH). LH and FSH control the production of female hormones (such as estrogen and
progesterone) and the development of eggs by the ovary. Progesterone and estrogen then
decrease the number of GnRH pulses produced by the brain (and therefore the number of LH
pulses from the pituitary). The ability to decrease GnRH pulses seems to be very important
for normal menstrual function in adult women. The purpose of this study is to learn more
about how GnRH and LH pulses are controlled during puberty. The information gathered in this
study will hopefully allow us to learn more about how menstrual cycles are normally
established in girls during puberty.
In this study, the investigators will aim to discover the effect of 7 days of estrogen and
progesterone on GnRH pulses in girls in early and mid puberty. Ultimately, if the
investigators understand these normal processes, the investigators may be able to better
understand abnormalities of puberty.
progesterone on GnRH pulses in girls in early and mid puberty. Ultimately, if the
investigators understand these normal processes, the investigators may be able to better
understand abnormalities of puberty.
Inclusion Criteria:
- Girls ages 8 to 14
- Tanner 1-3 pubertal stage
- Pre-menarchal
- Normal screening labs
Exclusion Criteria:
- Abnormal screening labs
- Congenital adrenal hyperplasia
- Hyperandrogenism (e.g., hirsutism, elevated free testosterone level)
- Hemoglobin <12 mg/dL or hematocrit < 36% (Subjects will be offered the opportunity to
take iron supplementation for 60 days if their hematocrit is slightly low (33-36%)
(suggestive of iron deficiency anemia) and will then return for retesting of their
hemoglobin/hematocrit.)
- Weight < 31 kg
- History of peanut allergy, deep venous thrombosis, breast cancer, endometrial cancer,
or cervical cancer
- On hormonal medications (including oral contraceptive pills) or on medications known
to affect the reproductive axis within 3 months of the study
- Pregnant or breast feeding
- Participation in a research study within the past 30 days that involved taking a study
drug.
- Participation in a research study that involved taking up to or greater than 473 ml's
of blood within the past 60 days.
- Cigarette smoking
- History of surgery that required bedrest within the past 30 days
- Family history of hypercoagulability or unexplained thromboembolic disease (not in
setting of bedrest, surgery, or malignancy)
- In order to ensure an adequate number of younger girls, no more than 4 enrolled
subjects will be Tanner stage 3
We found this trial at
1
site
Charlottesville, Virginia 22908
Principal Investigator: John C. Marshall, MD, PhD
Phone: 434-243-6911
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