A Phase 2 interventional study of Metformin and Placebo in Polycystic Ovary Syndrome, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to female participants aged 12 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-21.
Sponsored by Milton S. Hershey Medical Center · Phase 2, Interventional, and Treatment
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 114 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Metformin
Drug: Metformin · Behavioral: Lifestyle Intervention
Placebo
Drug: Placebo · Behavioral: Lifestyle Intervention
Medication was initiated in a step-up fashion every five days, from one tablet per day to four (500 mg per tablet).
Placebo
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.
Change in Testosterone After 6 Months of Treatment
Time frame: baseline and 6 months
Ovulation Rate
Count of ovulations per subject during the treatment period.
Time frame: 6 months
Change in Insulin Sensitivity Index After 6 Months of Treatment
Time frame: baseline and 6 months
| Milestone | Metformin | Placebo |
|---|---|---|
| Started | 55 | 59 |
| Completed | 22 | 16 |
| Not completed | 33 | 43 |
| Withdrew: Lost to follow-up | 15 | 19 |
| Withdrew: Withdrawal by subject | 12 | 20 |
| Withdrew: Adverse event | 6 | 0 |
| Withdrew: Pregnancy | 0 | 4 |
| ng/dL | Metformin | Placebo |
|---|---|---|
| Change in Testosterone After 6 Months of Treatment | -2.1 (-12.1 to 7.9) | -6.4 (-16.9 to 4.1) |
Count of ovulations per subject during the treatment period.
| Participants | Metformin | Placebo |
|---|---|---|
| 0 ovulations | 10 | 19 |
| 1 ovulation | 6 | 5 |
| 2 ovulations | 4 | 7 |
| 3 ovulations | 7 | 3 |
| 4 ovulations | 4 | 2 |
| 5 ovulations | 1 | 0 |
| 6+ ovulations | 5 | 3 |
| index | Metformin | Placebo |
|---|---|---|
| Change in Insulin Sensitivity Index After 6 Months of Treatment | 1.9 (-1.0 to 4.8) | -2.7 (-6.2 to 0.9) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Metformin | — | 0/55 (0%) | 38/55 (69.1%) |
| Placebo | — | 0/59 (0%) | 33/59 (55.9%) |
| Event | Metformin | Placebo |
|---|---|---|
| DiarrheaGastrointestinal disorders | 19/55 | 6/59 |
| common cold/respiratory tract infectionInfections and infestations | 12/55 | 13/59 |
| headache/migraineNervous system disorders | 12/55 | 11/59 |
| nausea and/or vomitingGastrointestinal disorders | 9/55 | 7/59 |
| dysmenorrhea/crampsReproductive system and breast disorders | 7/55 | 9/59 |
| musculoskeletalMusculoskeletal and connective tissue disorders | 5/55 | 9/59 |
| fluGastrointestinal disorders | 8/55 | 4/59 |
| stomach/abdominal pain or discomfortGastrointestinal disorders | 6/55 | 7/59 |
| altered mood/mood swingsNervous system disorders | 0/55 | 5/59 |
| fatigueNervous system disorders | 2/55 | 4/59 |
| Age, Categorical(Participants) | Metformin | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 55 | 59 | 114 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Metformin | Placebo | Total |
|---|---|---|---|
| Mean | 29 ± 4.5 | 28.8 ± 4.6 | 28.9 ± 4.6 |
| Sex: Female, Male(Participants) | Metformin | Placebo | Total |
|---|---|---|---|
| Female | 55 | 59 | 114 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Metformin | Placebo | Total |
|---|---|---|---|
| United States | 55 | 59 | 114 |
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Milton S. Hershey Medical Center