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| ID | Type | Description | Link |
|---|---|---|---|
| U54HD058155 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMI ≥30 kg/m2 | Active Comparator | Group 2:
Gonadorelin-GnRH (Lutrepulse), GnRH antagonists - Cetrorelix (Cetrotide), Recombinant LH (Luveris) were administered in Aim 1. GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. |
|
| BMI 18-25 kg/m2 | Experimental |
Gonadorelin-GnRH (Lutrepulse), GnRH antagonists - Cetrorelix (Cetrotide), Recombinant LH (Luveris) were administered in Aim 1. GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetrorelix | Drug | Abolishes pituitary sensitivity to GnRH. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1) | Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups. | Measured hourly and averaged over the 12 hour study visit |
| Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 2) | Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups. | Measured hourly and averaged over the 12 hour study visit |
| Changes in Pregnanediol Glucuronide (PdG) (Aim 2) | Pregnanediol glucuronide (PdG) was collected daily over the course of one menstrual cycle and averaged. | Averaged over the length of menstrual cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Follicle Stimulating Hormone (FSH) (Aim 1) | Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups. | Measured hourly and averaged over the 12 hour study visit |
| Changes in Follicle Stimulating Hormone (FSH) (Aim 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nanette Santoro, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Translational Research Center | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17440019 | Background | Jain A, Polotsky AJ, Rochester D, Berga SL, Loucks T, Zeitlian G, Gibbs K, Polotsky HN, Feng S, Isaac B, Santoro N. Pulsatile luteinizing hormone amplitude and progesterone metabolite excretion are reduced in obese women. J Clin Endocrinol Metab. 2007 Jul;92(7):2468-73. doi: 10.1210/jc.2006-2274. Epub 2007 Apr 17. | |
| 2818247 | Background | Haynes G, Bailey MK, Davis S, Mahaffey JE. Use of methylprednisolone in epidural analgesia. Arch Neurol. 1989 Nov;46(11):1167-8. doi: 10.1001/archneur.1989.00520470017014. No abstract available. |
| Label | URL |
|---|---|
| PI Biographical data | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | BMI ≥30 kg/m2 |
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology |
| FG001 | BMI 18-25 kg/m2 |
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BMI ≥30 kg/m2 |
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology |
| BG001 | BMI 18-25 kg/m2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1) | Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups. | This study was divided into two aims, and 10 obese and 10 normal weight women completed the study procedures and contributed data for analyses related to Aim 1. | Posted | Mean | Inter-Quartile Range | IU/L | Measured hourly and averaged over the 12 hour study visit |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BMI ≥30 kg/m2 |
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Regulatory Manager | University of Colorado Denver | 303-724-6501 | Chanel.mansfield@ucdenver.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C062876 | cetrorelix |
| D007987 | Gonadotropin-Releasing Hormone |
| D037101 | Luteinizing Hormone, beta Subunit |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Gonadorelin-GnRH | Drug | GnRH is used to stimulate the pituitary gland to produce LH and FSH. |
|
|
| Recombinant LH | Drug | Used to stimulate ovarian function in women. |
|
|
| Letrozole | Drug | An aromatase inhibitor. |
|
|
Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups. |
| Measured hourly and averaged over the 12 hour study visit |
| 18829008 | Background | Rochester D, Jain A, Polotsky AJ, Polotsky H, Gibbs K, Isaac B, Zeitlian G, Hickmon C, Feng S, Santoro N. Partial recovery of luteal function after bariatric surgery in obese women. Fertil Steril. 2009 Oct;92(4):1410-1415. doi: 10.1016/j.fertnstert.2008.08.025. Epub 2008 Sep 30. |
| 4729055 | Background | Santen RJ, Bardin CW. Episodic luteinizing hormone secretion in man. Pulse analysis, clinical interpretation, physiologic mechanisms. J Clin Invest. 1973 Oct;52(10):2617-28. doi: 10.1172/JCI107454. |
| 23958434 | Derived | Roth LW, Allshouse AA, Lesh J, Polotsky AJ, Santoro N. The correlation between self-reported and measured height, weight, and BMI in reproductive age women. Maturitas. 2013 Oct;76(2):185-8. doi: 10.1016/j.maturitas.2013.07.010. Epub 2013 Aug 16. |
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Gender | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI 18-25 kg/m2 |
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology |
|
|
| Primary | Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 2) | Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups. | This study was divided into two aims, and only 12 obese and 11 normal weight women completed the study procedures for Aim 2 that allowed measure of LH pulse amplitude. | Posted | Mean | Standard Deviation | IU/L | Measured hourly and averaged over the 12 hour study visit |
|
|
|
| Primary | Changes in Pregnanediol Glucuronide (PdG) (Aim 2) | Pregnanediol glucuronide (PdG) was collected daily over the course of one menstrual cycle and averaged. | This study was divided into two aims, and only 12 obese and 10 normal weight women completed the urine collection study procedures for Aim 2 that allowed measure of PdG. | Posted | Mean | Standard Deviation | ug/cycle | Averaged over the length of menstrual cycle |
|
|
|
| Secondary | Changes in Follicle Stimulating Hormone (FSH) (Aim 1) | Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups. | This study was divided into two aims, and only 10 obese and 10 normal weight women completed the study procedures for Aim 1 that allowed measure of FSH. | Posted | Mean | Inter-Quartile Range | IU/L | Measured hourly and averaged over the 12 hour study visit |
|
|
|
| Secondary | Changes in Follicle Stimulating Hormone (FSH) (Aim 2) | Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups. | This study was divided into two aims, and only 12 obese and 11 normal weight women completed the study procedures for Aim 2 that allowed measure of FSH. | Posted | Mean | Standard Deviation | IU/L | Measured hourly and averaged over the 12 hour study visit |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | BMI 18-25 kg/m2 |
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology | 0 | 33 | 0 | 33 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D007986 | Luteinizing Hormone |
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |