Last reviewed · How we verify
NCT00283816
Metabolic Impact of Oral Contraceptives With or Without Metformin in Obese Adolescents With Polycystic Ovary Syndrome (PCOS)
Phase 3 trial testing Metformin in Polycystic Ovary Syndrome in 36 participants. Completed in 1 January 2008.
1 January 2008
Quick facts
| Lead sponsor | University of Rochester |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 1 January 2006 |
| Primary completion | 1 January 2008 |
| Estimated completion | 1 January 2008 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Metformin (metformin) — full drug profile →
- Oral Contraceptive Pill — full drug profile →
- Lifestyle Management Program
- Quality of Life Questionnaire
- Oral Glucose Tolerance Test — full drug profile →
- Blood work
- Abdominal Ultra Sound
- Dual-energy x-ray absorptiometry (DEXA scan)
- placebo
Conditions studied
- Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →
Sponsor
University of Rochester
Who can join
Adults 12 to 18, female only, with Polycystic Ovary Syndrome. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Reduction in Abdominal Fat as Measured by Waist Circumference.
Time frame: baseline and 24 weeks
Change in waist circumference measured in cms used as a measure of abdominal adiposity, pre minus post intervention
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Drug repurposing for cancer therapy.
Xia Y, Sun M, Huang H, Jin WL. · · 2024 · cited 229× · PMID 38637540 · DOI 10.1038/s41392-024-01808-1 -
Recent trends in polycystic ovary syndrome treatment based on adult stem cell therapies.
Park H, Han JW, Kim GJ. · · 2025 · cited 1× · PMID 40114307 · DOI 10.5653/cerm.2024.07248
Verify or expand the search:
- PubMed search for NCT00283816
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Metformin
Trials testing the same drug.
- NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations · Phase 1 · not yet recruiting
- NCT07520110 — Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis · Phase 3 · not yet recruiting
- NCT07007221 — Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV · Phase 2 · not yet recruiting
- NCT07585396 — Inositol in Letrozol Resistant PCOS Women · Phase 2, PHASE3 · not yet recruiting
- NCT07226453 — Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymoma · Phase 2 · not yet recruiting
Other recruiting trials for Polycystic Ovary Syndrome
Currently open trials in the same condition.
- NCT07591246 — Efficay of Physical Activity Program in PCOS Females With Fatty Pancrease and Thyroid Hypofunction · NA · recruiting
- NCT07446985 — Is There a Benefit From Addition of Physical Exercise to Diet Restriction/Limitation in PCOS Women With Asthma? · NA · recruiting
- NCT07385716 — Evaluation of the Effect of Time-Restricted Feeding and Mediterranean Diet Model in Women With Polycystic Ovary Syndrome · NA · recruiting
- NCT07366944 — PCOS and Problem of Eye Dryness: Is There a Benefit From Lifetyle Changes · NA · recruiting
- NCT07289399 — Is There a Benefit From Addition of Treadmill Walking to Diet Restriction in Psoriasis Women With PCOS? · NA · recruiting
Other University of Rochester trials
Trials by the same sponsor.
- NCT07075965 — Calcium Channel Blocker in Myotonic Dystrophy Type 1 · Phase 1 · not yet recruiting
- NCT07423104 — A Study of Cladribine, Low Dose Cytarabine, and Venetoclax in Treatment of Relapsed/Refractory or Secondary Acute Myeloi · Phase 2 · not yet recruiting
- NCT05744869 — SBAT for Health Equity · NA · not yet recruiting
- NCT06052956 — Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses · Phase 2 · not yet recruiting
- NCT07032636 — Reducing Crises and Suicide Within the Idaho Army National Guard · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00283816 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Rochester
- Last refreshed: 28 April 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00283816.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing