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| ID | Type | Description | Link |
|---|---|---|---|
| HD-02-012 |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The purpose of this study is to determine if the combination therapy of lifestyle intervention and use of Metformin together will improve ovulation induction and hyperandrogenemia in women with polycystic ovary syndrome, by gathering data from adult and adolescent females.
PCOS is characterized by excess circulating androgen levels and chronic anovulation. PCOS is also characterized by insulin resistance and hyperinsulinemia. Several recent studies in a variety of non-hospital based populations have provided evidence that the incidence of hyperandrogenic chronic anovulation is in the range of 4-6% of the female population. Improvements in insulin sensitivity in women with PCOS, either through lifestyle changes or through pharmaceutical intervention, have consistently resulted in a marked improvement in the reproductive and metabolic abnormalities in PCOS. The primary objective in the adult female population is to determine that combination therapy will improve ovulatory frequency. Secondary objective is to improve circulating hyperandrogenemia and insulin sensitivity then single agent therapy. The primary objective of the adolescent population is to determine that the combination therapy will improve hyperandrogenemia. Secondary objective is to improve ovulatory frequency and insulin sensitivity than just the use of a single agent therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Experimental | Metformin |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Medication was initiated in a step-up fashion every five days, from one tablet per day to four (500 mg per tablet). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Testosterone After 6 Months of Treatment | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ovulation Rate | Count of ovulations per subject during the treatment period. | 6 months |
| Change in Insulin Sensitivity Index After 6 Months of Treatment | baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Legro, M.D. | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21704212 | Derived | Ladson G, Dodson WC, Sweet SD, Archibong AE, Kunselman AR, Demers LM, Lee PA, Williams NI, Coney P, Legro RS. Effects of metformin in adolescents with polycystic ovary syndrome undertaking lifestyle therapy: a pilot randomized double-blind study. Fertil Steril. 2011 Jun 30;95(8):2595-8.e1-6. doi: 10.1016/j.fertnstert.2011.05.048. | |
| 21193187 |
| Label | URL |
|---|---|
| Click here for more information about this study | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metformin | Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion |
| FG001 | Placebo | Placebo (2 tablets twice a day) initiated in a step-up fashion |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metformin | Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion |
| BG001 | Placebo | Placebo (2 tablets twice a day) initiated in a step-up fashion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Testosterone After 6 Months of Treatment | Posted | Least Squares Mean | 95% Confidence Interval | ng/dL | baseline and 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metformin | Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandy Eyer | Penn State Hershey | 717-531-1540 | seyer@hmc.psu.edu |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D000858 | Anovulation |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo |
|
| Lifestyle Intervention | Behavioral | A combined intervention of diet and exercise was employed with the goal of achieving an average weight loss of at least 7% of initial body weight over six months with a prescription of 150 min/week of exercise combined with a low-calorie diet. |
|
| Ladson G, Dodson WC, Sweet SD, Archibong AE, Kunselman AR, Demers LM, Williams NI, Coney P, Legro RS. The effects of metformin with lifestyle therapy in polycystic ovary syndrome: a randomized double-blind study. Fertil Steril. 2011 Mar 1;95(3):1059-66.e1-7. doi: 10.1016/j.fertnstert.2010.12.002. Epub 2010 Dec 30. |
| Adverse Event |
|
| Pregnancy |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Ovulation Rate | Count of ovulations per subject during the treatment period. | A total of 76 patients with daily urine collections. | Posted | Count of Participants | Participants | 6 months |
|
|
|
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| Secondary | Change in Insulin Sensitivity Index After 6 Months of Treatment | Posted | Least Squares Mean | 95% Confidence Interval | index | baseline and 6 months |
|
|
|
|
| 0 |
| 55 |
| 38 |
| 55 |
| EG001 | Placebo | Placebo (2 tablets twice a day) initiated in a step-up fashion | 0 | 59 | 33 | 59 |
| stomach/abdominal pain or discomfort | Gastrointestinal disorders |
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| nausea and/or vomiting | Gastrointestinal disorders |
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| flatulence | Gastrointestinal disorders |
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| flu | Gastrointestinal disorders |
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| common cold/respiratory tract infection | Infections and infestations |
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| dizziness | Nervous system disorders |
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| headache/migraine | Nervous system disorders |
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| fatigue | Nervous system disorders |
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| altered mood/mood swings | Nervous system disorders |
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| dysmenorrhea/cramps | Reproductive system and breast disorders |
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| vaginal infection | Reproductive system and breast disorders |
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| bladder infection | Renal and urinary disorders |
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| musculoskeletal | Musculoskeletal and connective tissue disorders |
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| hair loss | General disorders |
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| allergic reaction | General disorders |
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| dental issues | General disorders |
|
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| 2 ovulations |
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| 3 ovulations |
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| 4 ovulations |
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| 5 ovulations |
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| 6+ ovulations |
|
This statistical analysis models the count of ovulations provided a woman actually ovulated. |
| Zero-altered negative binomial model |
| 0.51 |
| rate ratio |
| 1.2 |
| 2-Sided |
| 95 |
| 0.7 |
| 1.9 |
Placebo is the reference group, i.e. for the rate ratio, Metformin represents the numerator and Placebo the denominator. |
| Superiority |