Trial · Interventional

CompletedNot applicableResults postedRegistry data

Estrogen Sensitivity and Ovulatory Dysfunction in Obesity

NCTNCT01381016Other id11-0293

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 30 participants (actual)
Sponsor: University of Colorado, Denver · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: Jun 2011
Primary completion: Jan 2013
Completion: Jan 2013
First posted: 27 Jun 2011 (estimated)
Last update posted: 20 Apr 2015 (estimated)
Conditions: Obesity · Infertility

Timeline

1 trial · 1 completed · 1 with posted results

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

2011201220132014

N/A
Estrogen Sensitivity and Ovulatory Dysfunction in Obesity
NCT01381016
Jun 2011 to Jan 2013

Registry summary

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

The sole purpose of this study is to evaluate pathophysiology of disease. The disease state that is being evaluated is the obesity-related alterations in reproductive hormones * The obesity epidemic in the United States is advancing at an accelerated pace. It is estimated that by 2015, 41% of U.S. adults will be obese as defined by a body mass index (BMI) of greater than 30 kg/m2. The U.S. government's 2010 Dietary Guidelines regard obesity as the single greatest health hazard in this century. Female adult obesity is associated with menstrual cycle irregularities, ovulatory dysfunction and a higher risk of obstetrical complications. This reproductive phenotype of obesity is worsened by further increases in BMI and is not solely due to anovulatory infertility. While the association of adiposity with subfertility is well documented in population studies, the underlying mechanisms remain poorly understood. The main objective of this proposal is to clarify the nature of the obesity-related reproductive endocrine abnormalities and identify potential etiologies amenable to therapy. * Hypothesis: The hypothalamic-pituitary axis is abnormally sensitive to estradiol negative feedback in obesity.

Interventions

EstradiolDrug
Gonadotropin-releasing hormone (GnRH)Drug
ProgesteroneDrug

Arms2

Other
Group 1 - Normal Weight
Group 1: Normal weight (BMI 18-25 kg/m2) Subjects were instructed to apply 0.1 mg/d transdermal estrogen (Estradiol) for one month. Pituitary response was assessed to determine how estradiol administration altered pituitary sensitivity to Gonadotropin-releasing hormone - GnRH. Subjects who failed to initiate a menstrual period following 40 days on the patch were instructed to take 200 mg daily of progesterone for 10 days or as long as deemed necessary.
Experimental
Group 2 - Obese
Group 2: Obese (BMI \>30 kg/m2) Subjects were instructed to apply 0.1 mg/d transdermal estrogen (Estradiol) for one month. Pituitary response was assessed to determine how estradiol administration altered pituitary sensitivity to Gonadotropin-releasing hormone - GnRH. Subjects who failed to initiate a menstrual period following 40 days on the patch were instructed to take 200 mg daily of progesterone for 10 days or as long as deemed necessary.

Primary outcomes2

Outcomes the sponsor listed as primary.

Luteinizing Hormone Pulse Amplitude
Time frame · Baseline
Registry description
The study is powered on luteinizing hormone pulse amplitude because it is the clinical outcome for which the most data is available. The primary comparison is whether there is a significant reduction in the pulse amplitude in the obese between the pre- and post-treatment periods and whether there is no change in the pulse amplitude in the normal weight patients between the pre and post-treatment periods.
Luteinizing Hormone Pulse Amplitude
Time frame · Post estradiol at one month

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· Baseline

Luteinizing Hormone Pulse Amplitude

Group	Value (IU/L)	Spread
Group 1 - Normal Weight	2.73	.46
Group 2 - Obese	1.12	.19

Primary outcomeMean· Post estradiol at one month

Luteinizing Hormone Pulse Amplitude

Group	Value (IU/L)	Spread
Control	2.18	.4
Experimental	1.59	.29

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
ControlGroup 1 "Control": Normal weight (BMI 18-25 kg/m2) Estradiol, Lutrelef or gonadorelin	–	0 / 11	0 / 11
ExperimentalGroup 2 "Experimental": Obese (BMI \>30 kg/m2) Estradiol, Lutrelef or gonadorelin	–	1 / 15	0 / 15

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 42 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Age 18-42 at study entry * Regular menstrual cycles every 25-40 days * BMI 18- 25 kg/m2 or ≥30kg/m2 * Good general health * Prolactin and thyroid-stimulating hormone (TSH) within normal laboratory ranges at screening * Baseline hemoglobin \>11 gm/dl. Exclusion Criteria: * Positive screen for Activated Protein C resistance * Any contraindications to exogenous estrogen, including previous thromboembolic events or stroke, history of an estrogen-dependent tumor, active liver disease, undiagnosed abnormal uterine bleeding, hypertriglyceridemia, smoking, hypertension * History of chronic disease affecting hormone production, metabolism or clearance (including diabetes mellitus) or abnormal renal or liver function at screening, such as elevated aspartate or alanine aminotransferases or elevated blood urea nitrogen (BUN) or creatinine * Current use of thiazolidinediones or metformin (known to interact with reproductive hormones) * Use of hormones affecting hypothalamic-pituitary ovarian axis within three months of enrollment * Strenuous exercise (\>4 hours per week) * Pregnancy, breast-feeding or current active attempts to conceive

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