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N/A N=62

Reproductive Hormonal Alterations in Obesity

Obesity

Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1) — 4.1; 3.6 IU/L

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Cetrorelix (Drug); Gonadorelin-GnRH (Drug); Recombinant LH (Drug); Letrozole (Drug)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
University of Colorado, Denver
Primary completion
Jul 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1)
4.1; 3.6
PRIMARY
Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 2)
2.21; 4.44
PRIMARY
Changes in Pregnanediol Glucuronide (PdG) (Aim 2)
54.1; 88.7
SECONDARY
Changes in Follicle Stimulating Hormone (FSH) (Aim 1)
3.8; 3.3
SECONDARY
Changes in Follicle Stimulating Hormone (FSH) (Aim 2)
5.31; 6.18

Summary

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 of the brain and the ovary to define the changes that happen leading to lowered hormone production. Women will be studied throughout a menstrual cycle and given medications that will test how well their pituitary gland can make hormones that stimulate the ovary (luteinizing hormone (LH) and follicle stimulating hormone (FSH)). They will also be given a medication to abolish estrogen production in the body and their response to this medication will be assessed. Finally, the ovary's ability to produce progesterone after ovulation will be examined. --Hypotheses: 1. Obese women have reduced pituitary sensitivity to exogenous gonadotropin-releasing hormone (GnRH), but normal clearance of exogenous LH. (comparative study of obese compared to normal weight women) 2. Obese women have abnormally increased sensitivity to estradiol negative feedback which will be reversed by an aromatase inhibitor. (comparative study of obese compared to normal weight women)

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01457703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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