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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: Clinical Trial Phase 3 study, sponsored by Pennington Biomedical Research Center.
NCT01482286 is a Phase 3 study that was terminated before completion, run by Pennington Biomedical Research Center. The registered enrollment target is 32 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in Luteinizing Hormone (LH) Pulse Frequency measured over a 12-hour period (7:00 PM - 7:00 AM). The Mean and Standard Deviation (SD) are the number of pulses recorded on the 12-hour period (7:00 PM - 7:00 AM) and presented as the change from baseline to week 24. Only participants who completed the PULSE trial are included in present outcome measure as the primary outcome was established as change from pre-to-post-intervention LF pulse frequency.
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 |
Why NCT01482286 stopped before completion
NCT01482286 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Exercise Training is the first listed.
NCT01482286 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01482286's enrollment target sits among peer trials
32 1909th of 2000 higher than 87 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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