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 is a Phase 3 study that has completed, run by University of Rochester. The registered enrollment target is 36 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00283816
The ClinicalTrials.gov registry entry for NCT00283816 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Metformin is the first listed.
NCT00283816 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.