Clinical trial · Interventional
Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy
Metabolic Impact of Oral Contraceptives With or Without Metformin in Obese Adolescents With Polycystic Ovary Syndrome (PCOS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abdominal Ultra Sound | Procedure | — | UNRESOLVED |
| Blood work | Procedure | — | UNRESOLVED |
| Dual-energy x-ray absorptiometry (DEXA scan) | Procedure | — | UNRESOLVED |
| Lifestyle Management Program | Behavioral | — | UNRESOLVED |
| Metformin | Drug | Metformin | ALIAS |
| Oral Contraceptive Pill | Drug | — | UNRESOLVED |
| Oral Glucose Tolerance Test | Procedure | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
| Quality of Life Questionnaire |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- metformin
- interventionNames
- Drug: Metformin
- Drug: Oral Contraceptive Pill
- Behavioral: Lifestyle Management Program
- Behavioral: Quality of Life Questionnaire
- Procedure: Oral Glucose Tolerance Test
- Procedure: Blood work
- Procedure: Abdominal Ultra Sound
- Procedure: Dual-energy x-ray absorptiometry (DEXA scan)
- type
- PLACEBO_COMPARATOR
- label
- 0
- description
- placebo
- interventionNames
- Drug: Oral Contraceptive Pill
- Behavioral: Lifestyle Management Program
- Behavioral: Quality of Life Questionnaire
- Procedure: Oral Glucose Tolerance Test
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 12 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:Age 12-18 years; Menstrual irregularity; Overweight; Must be able to swallow capsules; At lease 6 months since onset of first menstrual cycle. Exclusion Criteria:Diabetes; Kidney or Liver disease; Tobacco use; Depression or Bipolar Disease; Contraindication to exercise; Weight \> 300 lbs.
References
Publications (0)
Data not yet available