The impact of metformin, oral contraceptives, and lifestyle modification on polycystic ovary syndrome in obese adolescent women in two randomized, placebo-controlled clinical trials
Open accessAbstract
CONTEXT: Polycystic ovary syndrome (PCOS) presents in adolescence, and obesity is a common finding. The benefits and risks of alternate approaches to the management of PCOS in obese adolescent women are not clear. OBJECTIVE: We investigated the effects of metformin, oral contraceptives (OCs), and/or lifestyle modification in obese adolescent women with PCOS. DESIGN: Two small, randomized, placebo-controlled clinical trials were performed. PATIENTS AND PARTICIPANTS: A total of 79 obese adolescent women with PCOS participated. INTERVENTIONS: In the single treatment trial, subjects were randomized to metformin, placebo, a lifestyle modification program, or OC. In the combined treatment trial, all subjects received lifestyle modification and OC and were randomized to metformin or placebo. MAIN OUTCOME MEASURES: Serum concentrations of androgens and lipids were measured. RESULTS: Lifestyle modification alone resulted in a 59% reduction in free androgen index with a 122% increase in SHBG. OC resulted in a significant decrease in total testosterone (44%) and free androgen index (86%) but also resulted in an increase in C-reactive protein (39.7%) and cholesterol (14%). The combination of lifestyle modification, OC, and metformin resulted in a 55% decrease in total testosterone, as compared to 33% with combined treatment and placebo, a 4% reduction in waist circumference, and a significant increase in HDL (46%). CONCLUSIONS: In these preliminary trials, both lifestyle modification and OCs significantly reduce androgens and increase SHBG in obese adolescents with PCOS. Metformin, in combination with lifestyle modification and OC, reduces central adiposity, reduces total testosterone, and increases HDL, but does not enhance overall weight reduction.
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In Hoeger et al. (2008), IFG or IGT was seen in 25% of subjects at baseline (four IFG and six IGT) and one subject had type 2 diabetes, although assignment groups were not noted.
“In another study by Hoeger et al. (2008), IFG or IGT was seen in 25% of subjects at baseline (four IFG and six IGT) and one subject had DM2, although assignment groups were not noted.”
From Metformin and lifestyle modification in polycystic ovary syndrome: systematic review and meta-analysis (2015) · cites this paper as Hoeger et al. , 2008
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredAt study end, new onset IGT was noted in one subject on metformin and none on lifestyle in Hoeger et al. (2008).
“At study end, new onset IGT was noted in one subject on metformin and none on lifestyle (Hoeger et al. , 2008).”
From Metformin and lifestyle modification in polycystic ovary syndrome: systematic review and meta-analysis (2015) · cites this paper as Hoeger et al. , 2008
Participants with type 2 diabetes but not glucose intolerance were excluded before randomization in all studies except one (Hoeger et al., 2008).
“Participants with DM2 but not glucose intolerance were excluded before randomization in all studies except for one (Hoeger et al. , 2008).”
From Metformin and lifestyle modification in polycystic ovary syndrome: systematic review and meta-analysis (2015) · cites this paper as Hoeger et al. , 2008
A low-carbohydrate diet (20 to 40 g/d) and a hypocaloric diet (<40 g of fat per day) during 12 weeks improved weight and menstrual irregularities with no difference between the diets.
“A low-carbohydrate diet (20 to 40 g/d) and a hypocaloric diet (<40 g of fat per day) during 12 weeks improved weight and menstrual irregularities with no difference between the diets.”
From Polycystic Ovary Syndrome: Pathophysiology, Presentation, and Treatment With Emphasis on Adolescent Girls (2019) · cites this paper as [164]
Weight loss strategies up to 7% of body weight have resulted in improving menstrual irregularity and testosterone levels.
“Additionally, weight loss strategies up to 7% of body weight have resulted in improving menstrual irregularity and testosterone levels [164, 167].”
From Polycystic Ovary Syndrome: Pathophysiology, Presentation, and Treatment With Emphasis on Adolescent Girls (2019) · cites this paper as [164]
Lifestyle interventions in adolescents with PCOS have shown additional improvements in quality of life.
“Lifestyle interventions in adolescents with PCOS have shown additional improvements in quality of life [160, 164, 165].”
From Polycystic Ovary Syndrome: Pathophysiology, Presentation, and Treatment With Emphasis on Adolescent Girls (2019) · cites this paper as [164]
A meta-analysis of metformin use with and without lifestyle changes in PCOS (including two RCTs in adolescents) showed beneficial effects on BMI and menstrual cycles.
“A meta-analysis of metformin use with and without lifestyle changes in PCOS (including two RCTs in adolescents [164, 178]) showed beneficial effects on BMI and menstrual cycles [164, 178, 179].”
From Polycystic Ovary Syndrome: Pathophysiology, Presentation, and Treatment With Emphasis on Adolescent Girls (2019) · cites this paper as [164]
COCPs are associated with improvement in menstrual irregularity and acne according to a meta-analysis of metformin vs oral contraceptives in adolescents with PCOS.
“Metformin at a dose of 1700 to 2000 mg/d is associated with greater improvement of BMI, and COCPs are associated with improvement in menstrual irregularity and acne according to a meta-analysis of metformin vs oral contraceptives in adolescents with PCOS and including four RCTs (170 adolescents) [164, 180–184].”
From Polycystic Ovary Syndrome: Pathophysiology, Presentation, and Treatment With Emphasis on Adolescent Girls (2019) · cites this paper as [164]
Multiple observational studies and six RCTs evaluating the effect of metformin on a total of 275 adolescents with PCOS have demonstrated short-term beneficial effects mostly in adolescents with overweight/obesity.
“There have been multiple observational studies and six RCTs evaluating the effect of metformin on a total of 275 adolescents with PCOS. These studies have demonstrated short-term beneficial effects mostly in adolescents with overweight/obesity [164, 180–183].”
From Polycystic Ovary Syndrome: Pathophysiology, Presentation, and Treatment With Emphasis on Adolescent Girls (2019) · cites this paper as [164]
COCPs improve menstrual irregularity in adolescents with PCOS.
“COCPs improve menstrual irregularity in adolescents with PCOS [164, 180–184].”
From Polycystic Ovary Syndrome: Pathophysiology, Presentation, and Treatment With Emphasis on Adolescent Girls (2019) · cites this paper as [164]
Metformin at a dose of 1700 to 2000 mg/d is associated with greater improvement of BMI according to a meta-analysis of metformin vs oral contraceptives in adolescents with PCOS and including four RCTs (170 adolescents).
“Metformin at a dose of 1700 to 2000 mg/d is associated with greater improvement of BMI, and COCPs are associated with improvement in menstrual irregularity and acne according to a meta-analysis of metformin vs oral contraceptives in adolescents with PCOS and including four RCTs (170 adolescents) [164, 180–184].”
From Polycystic Ovary Syndrome: Pathophysiology, Presentation, and Treatment With Emphasis on Adolescent Girls (2019) · cites this paper as [164]
Metformin regimens in PCOS are not well standardised in research or clinical practice, with doses varying between 500 and 2550 mg per day and both standard and slow-release preparations available.
“Metformin regimens in PCOS are not well standardised in research or clinical practice, with doses varying between 500 and 2550 mg per day and both standard and slowrelease preparations available. 209”
From Assessment and management of polycystic ovary syndrome: Summary of an evidence-based guideline (2011) · cites this paper as [209]
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References 51 · Cited by 256
- Authors
- Hoeger, K., Davidson, K., Kochman, L., Cherry, T., Kopin, L., & Guzick, D. S.
- Affiliations
- University of Rochester Medicine (US)
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2008-11-01
- Volume
- 93
- Issue
- 11
- Pages
- 4299-4306
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- PMC
- PMC2582568
- OpenAlex
- W2054516673
- Cited by
- 256
- References
- 51
- Citations by year
- 2026: 5 · 2025: 8 · 2024: 11 · 2023: 12 · 2022: 7 · 2021: 7 · 2020: 24 · 2019: 14 · 2018: 14 · 2017: 17 · 2016: 10 · 2015: 20 · 2014: 18 · 2013: 13 · 2012: 13
- FWCI
- 24.33
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Virginia Commonwealth University
- National Institutes of Health (5k23hd043881-02)
- Medical Center, University of Pittsburgh
- Medical Center, University of Rochester
- National Center for Research Resources (UL1RR024160)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (K23 HD043881-01A1, 5 R03 HD41989-02, K23 HD043881, R03HD041989)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Health Sciences › Medicine › Reproductive Medicine › Endometriosis Research and Treatment
- Keywords
- polycystic ovary syndrome, adolescent obesity, metformin, oral contraceptives, lifestyle modification, androgens, free androgen index, sex hormone-binding globulin, total testosterone, C-reactive protein, HDL cholesterol, waist circumference, weight loss, combination therapy
- MeSH terms
- Adolescent, Androgens, Behavior Therapy, C-Reactive Protein, Child, Cholesterol, Contraceptives, Oral, Hormonal, Female, Humans, Hypoglycemic Agents, Life Style, Lipids, Metformin, Obesity, Placebos, Social Support, Testosterone
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