Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition (JCM026)

This study is ongoing, but not recruiting participants.

Sponsor:

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: May 26, 2017

Last verified: May 2017

History of Changes

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: None (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 John Marshall, 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 ]


Estimated Enrollment:	10
Actual Study Start Date:	January 27, 2009
Estimated Study Completion Date:	January 2020
Estimated Primary Completion Date:	January 9, 2018 (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)
Sexes 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

Locations


United States, Virginia
Center for Research in Reproduction, University of Virginia
Charlottesville, Virginia, United States, 22908

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 ( U.S. NIH Grant/Contract ) P50HD028934 ( U.S. NIH Grant/Contract )
Study First Received:	August 31, 2011
Last Updated:	May 26, 2017

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 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 21, 2017

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