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Convergent Mechanisms Underlying Reprometabolic Syndrome in Women

Convergent Mechanisms Underlying Reprometabolic Syndrome in Women and Sheep

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 38 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 weeks, 7 days
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study consists of 2 periods: a screening period of up to 3 weeks and a Treatment Period of 7-10 days."
  • "During the treatment period participants will wear estradiol patches for up to 7 days and have on blood draw on day 3 of wearing the patches."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether obesity changes how parts of the brain respond to estradiol, a type of estrogen. It looks at hormone signals that help control the release of eggs from the ovaries. The study is for women ages 18–38 who have regular periods.

Dr. Nanette Santoro proposes to test the specific question that obesity results in abnormal estradiol response at the level of the pituitary and hypothalamus. This will be shown in diminished pituitary sensitivity to gonadorelin releasing hormone with a reduced estradiol induced luteinizing hormone surge in obese women.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–38, with periods every 25–35 days.
  • No use of reproductive hormones in the past 3 months or medicines that affect these hormones.
  • Agree to use reliable barrier birth control, such as condoms, or not have sex during the study.
  • Normal blood tests for thyroid-stimulating hormone, prolactin, and blood fats.
  • No more than 4 hours of moderate to hard exercise each week.
  • No long-term disease that affects reproductive hormones.
  • No medical reason that makes taking estradiol unsafe, and no past cancer that depends on estrogen to grow.
  • A negative pregnancy test.

Who can't join

  • Have diabetes.
  • Smoke.
  • Have had a blood clot in a vein, or have a known condition that makes blood clot more easily.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age 18-38 * Regular menstrual cycles every 25-35 days * No use of reproductive hormones within the past 3 months * No use of medications interacting with reproductive hormones * Agreement to use reliable barrier contraception or to abstain from intercourse for the duration of the study * Normal thyroid stimulating hormone, prolactin and lipid profiles * No more than 4 hours of moderate to vigorous intensity exercise per week * No history of chronic disease impacting reproductive hormones * No contraindications to administration of estradiol * No history of estrogen dependent cancer * Negative pregnancy test Exclusion Criteria: * Has diabetes * Is a smoker * History of venous thromboembolism or known thrombophilia

Study sites (2)

CO