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NCT01381016 · ClinicalTrials.gov registry record · NA
Estrogen Sensitivity and Ovulatory Dysfunction in Obesity
A NA study of Obesity and Infertility, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01381016: Completed NA study of Obesity and Infertility, sponsored by University of Colorado, Denver.
NCT01381016 is a NA study of Obesity and Infertility that has completed, run by University of Colorado, Denver. The registered enrollment target is 30 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01381016, a NA study of Obesity and Infertility, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Progesterone
- DRUG Estradiol
- DRUG Gonadotropin-releasing hormone (GnRH)
Study Locations (1)
Colorado
- University of Colorado, Anschutz Medical Campus - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-01 |
| Phase | NA |
What the finished NCT01381016 record still lists
NCT01381016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 3 interventions - of which Progesterone is the first listed.
NCT01381016 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT01381016 about?
NCT01381016 is a clinical study titled "Estrogen Sensitivity and Ovulatory Dysfunction in Obesity". 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. ...
What is the current status of trial NCT01381016?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2011-06. Estimated completion is 2013-01.
What conditions does trial NCT01381016 study?
This clinical trial studies the following conditions: Obesity, Infertility.
What interventions are being tested in trial NCT01381016?
The interventions under investigation include: Progesterone (DRUG), Estradiol (DRUG), Gonadotropin-releasing hormone (GnRH) (DRUG).
Who is sponsoring clinical trial NCT01381016?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01381016 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01381016's enrollment target sits among peer trials
30 851st of 1053 higher than 173 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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