Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00283816 · ClinicalTrials.gov registry record · Phase 3
Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy
A Phase 3 study, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 3
- Development phase
- 36
- Enrollment target
NCT00283816: Completed Phase 3 study, sponsored by University of Rochester.
NCT00283816 is a Phase 3 study that has completed, run by University of Rochester. The registered enrollment target is 36 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00283816, a Phase 3 study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 36 participants
- Enrollment target
Study Summary
Oral contraceptives are known to improve menstrual cycles and symptoms in PCOS, however may increase cholesterol. Metformin, a drug to improve insulin resistance, may benefit metabolic state. This study is to determine whether metformin added to oral contraceptive therapy in adolescent women with PCOS improves metabolic state.The study will also test a lifestyle improvement program to reduce weight.
Primary Outcome
Change in waist circumference measured in cms used as a measure of abdominal adiposity, pre minus post intervention
Interventions
- DRUG Metformin
- BEHAVIORAL Quality of Life Questionnaire
- DRUG Oral Contraceptive Pill
- BEHAVIORAL Lifestyle Management Program
- PROCEDURE Oral Glucose Tolerance Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2006-01 |
| Est. Completion | 2008-01 |
| Phase | Phase 3 |
What the finished NCT00283816 record still lists
NCT00283816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which Metformin is the first listed.
NCT00283816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00283816 about?
NCT00283816 is a clinical study titled "Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy". Oral contraceptives are known to improve menstrual cycles and symptoms in PCOS, however may increase cholesterol. Metformin, a drug to improve insulin resistance, may benefit metabolic state. This study is to determine whether metformin added to oral contraceptive therapy in adolescent women with PC...
What is the current status of trial NCT00283816?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 36 participants. The study started on 2006-01. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00283816?
The interventions under investigation include: Metformin (DRUG), Quality of Life Questionnaire (BEHAVIORAL), Oral Contraceptive Pill (DRUG), Lifestyle Management Program (BEHAVIORAL), Oral Glucose Tolerance Test (PROCEDURE).
Who is sponsoring clinical trial NCT00283816?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00283816's enrollment target sits among peer trials
36 1901st of 2000 higher than 98 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00929006 · 36 participants · Early Phase 1
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
- NCT01891318 · 36 participants · Phase 1
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
- NCT02291848 · 36 participants · Phase 1
Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma
- NCT02366819 · 36 participants · Phase 4
Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia