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NCT01482286 · ClinicalTrials.gov registry record · Phase 3
Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS
A Phase 3 study, sponsored by Pennington Biomedical Research Center.
- Terminated
- Registry status
- Phase 3
- Development phase
- 32
- Enrollment target
NCT01482286 is a Phase 3 study that was terminated before completion, run by Pennington Biomedical Research Center. The registered enrollment target is 32 participants.
The verdict
NCT01482286, a Phase 3 study, was terminated before completion, sponsored by Pennington Biomedical Research Center.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 32 participants
- Enrollment target
Study Summary
Polycystic ovary syndrome (PCOS) is the most common reproductive disorder in women of reproductive age and despite decades of research the etiology the disorder is not known. The characteristic hyperandrogenism and anovulation is associated with abnormal neuroendocrine function and insulin resistance. Obesity is a common correlated phenotype of Polycystic ovary syndrome and weight gain worsens the reproductive and metabolic complications. Currently there is no evidence-based treatment plan for infertility in Polycystic ovary syndrome; yet weight loss by dietary restriction and regular exercise are strongly advocated. Weight loss and increased insulin sensitivity appear to drive improvements in reproductive outcomes in women with Polycystic ovary syndrome; however, the mechanism connecting these changes with the reproductive axis is not fully understood.
Interventions
- BEHAVIORAL Exercise Training
- DRUG Metformin
- BEHAVIORAL Dietary Restriction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2012-05 |
| Est. Completion | 2016-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01482286
The ClinicalTrials.gov registry entry for NCT01482286 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pennington Biomedical Research Center, which has 258 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Exercise Training is the first listed.
NCT01482286 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01482286 about?
NCT01482286 is a clinical study titled "Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS". Polycystic ovary syndrome (PCOS) is the most common reproductive disorder in women of reproductive age and despite decades of research the etiology the disorder is not known. The characteristic hyperandrogenism and anovulation is associated with abnormal neuroendocrine function and insulin resistanc...
What is the current status of trial NCT01482286?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 32 participants. The study started on 2012-05. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01482286?
The interventions under investigation include: Exercise Training (BEHAVIORAL), Metformin (DRUG), Dietary Restriction (BEHAVIORAL).
Who is sponsoring clinical trial NCT01482286?
This trial is sponsored by Pennington Biomedical Research Center, which has 258 total clinical trials registered on ClinicalTrials.gov.
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