WithdrawnNot Applicable

FHA: Characterization of Metabolic Status, Brain Circuitry, and Stress-Reactivity

Stopped: prior to participant recruitment, PI left Emory, study stopped

United States0Started 2011-07

Plain-language summary

Functional Hypothalamic Amenorrhea (FHA), the spontaneous cessation of the menstrual cycle for at least 6 months after menstrual cyclicity has been established, is a common and reversible form of anovulation not due to discernible organic causes. Whereas animal studies suggest an interaction of metabolic and psychosocial stress in the genesis of FHA, the distinct central mechanisms in humans are not clear. On a behavioral level, FHA appears to depend on a complex interplay between individual stress susceptibility, stressful life events, and enduring metabolic challenge due to inappropriate attitudes towards eating and body image. We will use a comparison group of ovulatory, eumenorrheic women (EW) and a contrast group of lean women with polycystic ovary syndrome (PCOS). Although women with FHA and PCOS present with anovulation, each condition differs markedly in pathobiology (and health burden). Contrasting women with FHA to those with PCOS will afford an opportunity to understand more about the interaction between metabolism, stress, and reproduction and to determine the extent to which differences between FHA and EW are attributable to reproductive compromise (anovulation) per se versus specific to the pathogenesis of FHA or PCOS. We have used this approach to great advantage in the past to show that hypercortisolemia was confined to FHA and not PCOS (Berga 1997) and that dysfunctional (unrealistic) attitudes and decreased coping skills were reported more often in FHA than in PCOS and more in PCOS than EW. Further, this approach of comparing 3 groups will allow us to improve therapeutic approaches for two principle causes of anovulatory infertility in women. To accomplish this, we will study women with FHA, PCOS, and normal ovulatory women. The study will take place over 2 months and women will make 4-5 outpatient visits to the Clinical Integration Network Center and will have one overnight stay for frequent blood sampling.

Who can participate

Age range

18 Years – 35 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: * Inclusion criteria for participation are a gynecological age (age since menarche) \> 5 and \< 25 years, and chronological age \> 18 years, within 90-110% of ideal body weight as determined by the 1983 Metropolitan height and weight table for women, and exercise \< 10 h/wk and run \< 10 mi/wk, day-awake/night-asleep schedule. * Women in the FHA and PCOS groups have to fulfill the diagnostic criteria of FHA or PCOS and to have all other causes of amenorrhea and anovulation excluded. Exclusion Criteria: * Exclusion criteria are smoking, medications, including psychotropic or illicit drugs, medical, neurological, or ophthalmologic disease except acuity problems, a weight loss or gain of \> 10 lb within a year preceding or since the onset of amenorrhea, a major Axis I disorder other than depression, parturition in the last 12 months and/or lactating in the last 6 months.

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.

Trial details

NCT IDNCT00453219

SponsorEmory University

Sponsor typeOTHER

Study typeOBSERVATIONAL

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