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

Primary Purpose

Hyperandrogenemia, Polycystic Ovary Syndrome

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Progesterone

Estrace (estrogen)

About this trial

This is an interventional basic science trial for Hyperandrogenemia

Eligibility Criteria

8 Years - 14 Years (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Center for Research in Reproduction, University of Virginia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Progesterone, estrace

Arm Description

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

Outcomes

Primary Outcome Measures

LH Pulse Frequency as a Function of Day 7 Progesterone

number of LH pulses per 11 hours on Day 7 of progesterone

Secondary Outcome Measures

Full Information

NCT ID

NCT01428245

First Posted

August 31, 2011

Last Updated

December 3, 2020

Sponsor

University of Virginia

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

1. Study Identification

Unique Protocol Identification Number

NCT01428245

Brief Title

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

Acronym

JCM026

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Terminated

Why Stopped

The research questions was changed/de-prioritized. Only one subject completed.

Study Start Date

April 22, 2011 (Actual)

Primary Completion Date

May 14, 2013 (Actual)

Study Completion Date

May 14, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Virginia

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperandrogenemia, Polycystic Ovary Syndrome

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Progesterone, estrace

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Progesterone

Intervention Description

oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days

Intervention Type

Drug

Intervention Name(s)

Estrace (estrogen)

Other Intervention Name(s)

estradiol

Intervention Description

oral estrace, 0.5-1 mg once a day for seven days

Primary Outcome Measure Information:

Title

LH Pulse Frequency as a Function of Day 7 Progesterone

Description

number of LH pulses per 11 hours on Day 7 of progesterone

Time Frame

7 days following oral estrace and progesterone administration

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John C. Marshall, MD, PhD

Organizational Affiliation

University of Virginia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Research in Reproduction, University of Virginia

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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