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Reproductive Hormonal Alterations in Obesity | Clinical Trials | Clareo Health

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COMPLETEDNANCT01457703

Reproductive Hormonal Alterations in Obesity

The purpose of this study is to determine why obese women have lower hormone levels and less fertility than women of normal body weight. The proposal will examine the reproductive system at the level ...

Lead sponsor: University of Colorado, Denver•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of Colorado, Denver

Collaborators

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

AIM 1: test the hypothesis that reduced pituitary sensitivity to GnRH-induced LH and FSH secretion causes the relative hypogonadotropic hypogonadism of obesity AIM 2: test the hypothesis that the hypothalamic-pituitary axis is abnormally sensitive to estradiol negative feedback in obesity

Age

18 - 40 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Aged 18-40 at study entry
•BMI either 18-25 kg/m2 or ≥30 kg/m2
•prolactin (PRL) and thyroid-stimulating hormone (TSH) within normal laboratory ranges at screening
•Baseline hemoglobin \>11 gm/dl
•History of regular menstrual cycles every 25-35 days if BMI 18-25 kg/m2
•History of regular menstrual cycles every 25-40 days if BMI ≥30 kg/m2

Exclusion Criteria

•History of chronic disease affecting hormone production, metabolism or clearance
•Use of medications that are known to alter or interact with reproductive hormones (e.g., thiazolidinediones, metformin)
•Use of hormones within three months of enrollment
•Excessive exercise (\>4 hours per week)
•Pregnancy, breast-feeding or current active attempts to conceive

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 12, 2017Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment62

Start dateJun 2010

Last updatedJan 12, 2017

Condition

Locations shown

Clinical Translational Research Center

Aurora, Colorado

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2017Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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