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NCT01457703 · ClinicalTrials.gov registry record · NA
Reproductive Hormonal Alterations in Obesity
A NA study of Obesity, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 62
- Enrollment target
- 1
- Study location
NCT01457703: Completed NA study of Obesity, sponsored by University of Colorado, Denver.
NCT01457703 is a NA study of Obesity that has completed, run by University of Colorado, Denver. The registered enrollment target is 62 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01457703, a NA study of Obesity, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 62 participants
- Enrollment target
- 1
- Study location
Study 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)
Primary Outcome
Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.
Conditions Studied
Interventions
- DRUG Letrozole
- DRUG Cetrorelix
- DRUG Gonadorelin-GnRH
- DRUG Recombinant LH
Study Locations (1)
Colorado
- Clinical Translational Research Center - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2010-06 |
| Est. Completion | 2013-07 |
| Phase | NA |
What the finished NCT01457703 record still lists
NCT01457703 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 4 interventions - of which Letrozole is the first listed.
NCT01457703 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT01457703 about?
NCT01457703 is a clinical study titled "Reproductive Hormonal Alterations in Obesity". 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. ...
What is the current status of trial NCT01457703?
This trial is currently completed. It is a NA study. The enrollment target is 62 participants. The study started on 2010-06. Estimated completion is 2013-07.
What conditions does trial NCT01457703 study?
This clinical trial studies the following conditions: Obesity.
What interventions are being tested in trial NCT01457703?
The interventions under investigation include: Letrozole (DRUG), Cetrorelix (DRUG), Gonadorelin-GnRH (DRUG), Recombinant LH (DRUG).
Who is sponsoring clinical trial NCT01457703?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01457703 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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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01457703's enrollment target sits among peer trials
62 632nd of 1053 higher than 418 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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