TerminatedNot Applicable

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

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

United States3 participantsStarted 2011-04-22

Plain-language 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.

Who can participate

Age range

8 Years – 14 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

LH Pulse Frequency as a Function of Day 7 Progesterone

Timeframe: 7 days following oral estrace and progesterone administration

Trial details

NCT IDNCT01428245

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-05-14

Results submitted2020-11-10

View on ClinicalTrials.gov More Hyperandrogenemia trials