Trial · Interventional

CompletedNot applicableResults postedRegistry data

Reproductive Hormonal Alterations in Obesity

NCTNCT01457703Other id09-0977Other idU54HD058155

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Overview

Status: Completed
Phase: Not applicable
Enrollment: 62 participants (actual)
Sponsor: University of Colorado, Denver · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: Jun 2010
Primary completion: Jul 2013
Completion: Jul 2013
First posted: 24 Oct 2011 (estimated)
Last update posted: 12 Jan 2017 (estimated)
Conditions: Obesity

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20102011201220132014

N/A
Reproductive Hormonal Alterations in Obesity
NCT01457703
Jun 2010 to Jul 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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)

Interventions

CetrorelixDrug
Gonadorelin-GnRHDrug
Recombinant LHDrug
LetrozoleDrug

Arms2

Active comparator
BMI ≥30 kg/m2
Group 2: * BMI ≥30 kg/m2 * History of regular menstrual cycles every 25-40 days 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.
Experimental
BMI 18-25 kg/m2
* BMI 18-25 kg/m2 * History of regular menstrual cycles every 25-35 days 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.

Primary outcomes3

Outcomes the sponsor listed as primary.

Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1)
Time frame · Measured hourly and averaged over the 12 hour study visit
Registry description
Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.
Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 2)
Time frame · Measured hourly and averaged over the 12 hour study visit
Registry description
Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.
Changes in Pregnanediol Glucuronide (PdG) (Aim 2)
Time frame · Averaged over the length of menstrual cycle
Registry description
Pregnanediol glucuronide (PdG) was collected daily over the course of one menstrual cycle and averaged.

Secondary outcomes(2)

Changes in Follicle Stimulating Hormone (FSH) (Aim 1)
Time frame · Measured hourly and averaged over the 12 hour study visit
Registry description
Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.
Changes in Follicle Stimulating Hormone (FSH) (Aim 2)
Time frame · Measured hourly and averaged over the 12 hour study visit
Registry description
Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Measured hourly and averaged over the 12 hour study visit

Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1)

Group	Value (IU/L)
BMI ≥30 kg/m2	4.1
BMI 18-25 kg/m2	3.6

Primary outcomeMean· Measured hourly and averaged over the 12 hour study visit

Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 2)

Group	Value (IU/L)	Spread
BMI ≥30 kg/m2	2.21	.32
BMI 18-25 kg/m2	4.44	1.03

Primary outcomeMean· Averaged over the length of menstrual cycle

Changes in Pregnanediol Glucuronide (PdG) (Aim 2)

Group	Value (ug/cycle)	Spread
BMI ≥30 kg/m2	54.1	33
BMI 18-25 kg/m2	88.7	64.6

Secondary and other outcome results(2)

Secondary outcomeMean· Measured hourly and averaged over the 12 hour study visit

Changes in Follicle Stimulating Hormone (FSH) (Aim 1)

Group	Value (IU/L)
BMI ≥30 kg/m2	3.8
BMI 18-25 kg/m2	3.3

Secondary outcomeMean· Measured hourly and averaged over the 12 hour study visit

Changes in Follicle Stimulating Hormone (FSH) (Aim 2)

Group	Value (IU/L)	Spread
BMI ≥30 kg/m2	5.31	.38
BMI 18-25 kg/m2	6.18	.94

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
BMI ≥30 kg/m2* BMI ≥30 kg/m2 * History of regular menstrual cycles every 25-40 days Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology	–	0 / 29	0 / 29
BMI 18-25 kg/m2* BMI 18-25 kg/m2 * History of regular menstrual cycles every 25-35 days Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology	–	0 / 33	0 / 33

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedRoth 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. PMID 23958434

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 40 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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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