Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition in Early Pubertal Girls (JCM026)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hyperandrogenemia Polycystic Ovary Syndrome |
Drug: Progesterone Drug: Estrace (estrogen) |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition in Early Pubertal Girls (JCM026) |
- LH Pulse frequency as a function of day 7 progesterone [ Time Frame: 7 days following oral estrace and progesterone administration ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Progesterone, estrace
oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr to achieve mean plasma concentrations over the range of 2-8 ng/ml for seven days oral estrace, 0.5-1 mg once a day for seven days |
Drug: Progesterone
oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days
Drug: Estrace (estrogen)
oral estrace, 0.5-1 mg once a day for seven days
Other Name: estradiol
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 8 Years to 14 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Michelle Y. Abshire, PhD | 434-243-6911 | pcos@virginia.edu |
| Contact: John C. Marshall, MD, PhD | 434-243-6911 | pcos@virginia.edu |
| United States, Virginia | |
| Center for Research in Reproduction, University of Virginia | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Michelle Y. Abshire, PhD 434-243-6911 pcos@virginia.edu | |
| Principal Investigator: John C. Marshall, MD, PhD | |
| Principal Investigator: | John C. Marshall, MD, PhD | University of Virginia |
More Information
No publications provided
| Responsible Party: | John Marshall, Director, Center for Research in Reproduction, University of Virginia |
| ClinicalTrials.gov Identifier: | NCT01428245 History of Changes |
| Other Study ID Numbers: | 14100, U54HD028934-18 |
| Study First Received: | August 31, 2011 |
| Last Updated: | June 12, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Polycystic Ovary Syndrome Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Estradiol Polyestradiol phosphate Estrogens Progesterone |
Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female Progestins |
ClinicalTrials.gov processed this record on May 22, 2013