Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition (JCM026)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified August 2015 by University of Virginia
Sponsor:
University of Virginia
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
John Marshall, University of Virginia
ClinicalTrials.gov Identifier:
NCT01428245
First received: August 31, 2011
Last updated: August 31, 2015
Last verified: August 2015
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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) |
Resource links provided by NLM:
Drug Information available for:
Estradiol
Progesterone
Estradiol cypionate
Estradiol valerate
Estradiol acetate
Estradiol hemihydrate
U.S. FDA Resources
Further study details as provided by University of Virginia:
Primary Outcome Measures:
- 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: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (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 (Child) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428245
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428245
Contacts
| Contact: Cinthya Obando Perez | 434-243-6911 | pcos@virginia.edu | |
| Contact: John C Marshall, MD, PhD | 434-243-6911 | pcos@virginia.edu |
Locations
| United States, Virginia | |
| Center for Research in Reproduction, University of Virginia | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Cinthya Obando Perez 434-243-6911 pcos@virginia.edu | |
| Principal Investigator: John C. Marshall, MD, PhD | |
Sponsors and Collaborators
University of Virginia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
| Principal Investigator: | John C. Marshall, MD, PhD | University of Virginia |
More Information
| 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 P50HD028934 |
| Study First Received: | August 31, 2011 |
| Last Updated: | August 31, 2015 |
| 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 Estrogens Estradiol Polyestradiol phosphate |
Progesterone Estradiol 3-benzoate Estradiol 17 beta-cypionate Estradiol valerate Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female Progestins |
ClinicalTrials.gov processed this record on September 30, 2016