Trial Outcomes & Findings for Comparing the Effects of Oral Contraceptive Pills Versus Metformin (NCT NCT03229057)
NCT ID: NCT03229057
Last Updated: 2025-11-05
Results Overview
Our primary goal is to determine the effect of 6 months' treatment with OCP vs. metformin vs. OCP + metformin on prevalence of MetS and its components in overweight / obese women. Implicit in the primary aim is clearly defining MetS, by NCEP ATPIII criteria as the presence of at least 3 of the following 5 criteria: TG≥150mg/dl, HDL-C\<50mg/dl, BP≥130/≥85mmHg, WC\>88cm and fasting glucose≥100mg/dl; and the goal of tracking safety of our interventions at all Phases of the study (through safety lab evaluations, vital signs and diaries)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
240 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2025-11-05
Participant Flow
Participant milestones
| Measure |
OCP + Placebo
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Placebo pills will be administered to individuals randomized to OCP only in order to maintain study blinding.
OCP + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
Metformin + Placebo
Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. Placebo pills will be administered to individuals randomized to metformin only in order to maintain study blinding.
Metformin + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
OCP + Metformin
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg.
OCP + Metformin: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
|---|---|---|---|
|
Overall Study
End of study outcome
|
59
|
65
|
63
|
|
Overall Study
COMPLETED
|
52
|
60
|
57
|
|
Overall Study
NOT COMPLETED
|
27
|
21
|
23
|
|
Overall Study
STARTED
|
79
|
81
|
80
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baseline menses data were missing for 7 participants.
Baseline characteristics by cohort
| Measure |
OCP + Placebo
n=79 Participants
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Placebo pills will be administered to individuals randomized to OCP only in order to maintain study blinding.
OCP + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
Metformin + Placebo
n=81 Participants
Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. Placebo pills will be administered to individuals randomized to metformin only in order to maintain study blinding.
Metformin + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
OCP + Metformin
n=80 Participants
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg.
OCP + Metformin: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.1 years
STANDARD_DEVIATION 4.8 • n=79 Participants
|
30.1 years
STANDARD_DEVIATION 5.3 • n=81 Participants
|
29.2 years
STANDARD_DEVIATION 5.4 • n=80 Participants
|
29.5 years
STANDARD_DEVIATION 5.2 • n=240 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=79 Participants
|
81 Participants
n=81 Participants
|
80 Participants
n=80 Participants
|
240 Participants
n=240 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=79 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=240 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=79 Participants
|
17 Participants
n=81 Participants
|
14 Participants
n=80 Participants
|
42 Participants
n=240 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=79 Participants
|
64 Participants
n=81 Participants
|
66 Participants
n=80 Participants
|
198 Participants
n=240 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=79 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=240 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=79 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=240 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=79 Participants
|
3 Participants
n=81 Participants
|
3 Participants
n=80 Participants
|
11 Participants
n=240 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=79 Participants
|
1 Participants
n=81 Participants
|
0 Participants
n=80 Participants
|
1 Participants
n=240 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=79 Participants
|
16 Participants
n=81 Participants
|
19 Participants
n=80 Participants
|
54 Participants
n=240 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=79 Participants
|
59 Participants
n=81 Participants
|
57 Participants
n=80 Participants
|
169 Participants
n=240 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=79 Participants
|
2 Participants
n=81 Participants
|
1 Participants
n=80 Participants
|
5 Participants
n=240 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=79 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=240 Participants
|
|
Menses per year
|
4.7 menses per year
STANDARD_DEVIATION 3.2 • n=75 Participants • Baseline menses data were missing for 7 participants.
|
5.7 menses per year
STANDARD_DEVIATION 3.8 • n=79 Participants • Baseline menses data were missing for 7 participants.
|
4.8 menses per year
STANDARD_DEVIATION 3.3 • n=79 Participants • Baseline menses data were missing for 7 participants.
|
5.1 menses per year
STANDARD_DEVIATION 3.4 • n=233 Participants • Baseline menses data were missing for 7 participants.
|
|
Percentage of Nulliparous
|
56 Participants
n=79 Participants
|
57 Participants
n=81 Participants
|
58 Participants
n=80 Participants
|
171 Participants
n=240 Participants
|
|
Count of Current Smokers
|
6 Participants
n=79 Participants
|
5 Participants
n=81 Participants
|
5 Participants
n=80 Participants
|
16 Participants
n=240 Participants
|
|
Percentage of Participants on Hypertension Medications
|
7 Participants
n=79 Participants
|
2 Participants
n=81 Participants
|
2 Participants
n=80 Participants
|
11 Participants
n=240 Participants
|
|
Percentage of Participants with Prediabetes, based on HbA1C
|
27 Participants
n=79 Participants
|
27 Participants
n=81 Participants
|
27 Participants
n=80 Participants
|
81 Participants
n=240 Participants
|
|
Waist measurement
|
108.0 cm
STANDARD_DEVIATION 12.8 • n=79 Participants
|
107.4 cm
STANDARD_DEVIATION 15.6 • n=81 Participants
|
109.0 cm
STANDARD_DEVIATION 16.4 • n=80 Participants
|
108 cm
STANDARD_DEVIATION 15.0 • n=240 Participants
|
|
Systolic Blood Pressure
|
116.8 mmHg
STANDARD_DEVIATION 9.8 • n=79 Participants
|
116.9 mmHg
STANDARD_DEVIATION 10.1 • n=81 Participants
|
117.0 mmHg
STANDARD_DEVIATION 8.4 • n=80 Participants
|
116.9 mmHg
STANDARD_DEVIATION 9.5 • n=240 Participants
|
|
Diastolic Blood Pressure
|
76.8 mmHG
STANDARD_DEVIATION 7.3 • n=79 Participants
|
77.7 mmHG
STANDARD_DEVIATION 6.4 • n=81 Participants
|
76.9 mmHG
STANDARD_DEVIATION 6.3 • n=80 Participants
|
77.1 mmHG
STANDARD_DEVIATION 6.8 • n=240 Participants
|
|
Fasting glucose value from safety labs
|
78.1 mg/dL
STANDARD_DEVIATION 14.7 • n=79 Participants
|
77.6 mg/dL
STANDARD_DEVIATION 17.0 • n=81 Participants
|
74.2 mg/dL
STANDARD_DEVIATION 15.8 • n=80 Participants
|
76.6 mg/dL
STANDARD_DEVIATION 15.9 • n=240 Participants
|
|
Triglycerides
|
102.0 mg/dL
n=79 Participants
|
90.0 mg/dL
n=81 Participants
|
97.0 mg/dL
n=80 Participants
|
97.5 mg/dL
n=240 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: Includes all participants who completed an end of study visit greater than or equal to 16 weeks.
Our primary goal is to determine the effect of 6 months' treatment with OCP vs. metformin vs. OCP + metformin on prevalence of MetS and its components in overweight / obese women. Implicit in the primary aim is clearly defining MetS, by NCEP ATPIII criteria as the presence of at least 3 of the following 5 criteria: TG≥150mg/dl, HDL-C\<50mg/dl, BP≥130/≥85mmHg, WC\>88cm and fasting glucose≥100mg/dl; and the goal of tracking safety of our interventions at all Phases of the study (through safety lab evaluations, vital signs and diaries)
Outcome measures
| Measure |
OCP + Placebo
n=59 Participants
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Placebo pills will be administered to individuals randomized to OCP only in order to maintain study blinding.
OCP + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
Metformin + Placebo
n=65 Participants
Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. Placebo pills will be administered to individuals randomized to metformin only in order to maintain study blinding.
Metformin + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
OCP + Metformin
n=63 Participants
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg.
OCP + Metformin: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
|---|---|---|---|
|
Number of Participants With Metabolic Syndrome After 6 Months of Treatment Metformin or OCP+Metformin for 6 Months.
|
17 Participants
|
17 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Uses all available data, Intent to Treat
This will be measured by NMR spectroscopy
Outcome measures
| Measure |
OCP + Placebo
n=79 Participants
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Placebo pills will be administered to individuals randomized to OCP only in order to maintain study blinding.
OCP + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
Metformin + Placebo
n=81 Participants
Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. Placebo pills will be administered to individuals randomized to metformin only in order to maintain study blinding.
Metformin + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
OCP + Metformin
n=80 Participants
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg.
OCP + Metformin: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
|---|---|---|---|
|
Changes in Serum Apoliprotein B From Baseline to 6 Months
|
.03 g/L
Interval -0.02 to 0.06
|
0.003 g/L
Interval -0.03 to 0.04
|
0.05 g/L
Interval 0.01 to 0.09
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: The study team planned to complete this outcome, however, we did not have funding to complete the outcome and there is no plan to run this analysis in the future. Therefore we have no results to report, nor will we in the future.
Serum adipokines to be measured are adiponectin and leptin. These changes will be correlated with changes in serum and androgens and markers of insulin sensitivity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Uses all available data, Intent to Treat
Body fat distribution will be measured by DXA. These changes will be correlated with changes in serum and androgens and markers of insulin sensitivity
Outcome measures
| Measure |
OCP + Placebo
n=79 Participants
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Placebo pills will be administered to individuals randomized to OCP only in order to maintain study blinding.
OCP + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
Metformin + Placebo
n=81 Participants
Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. Placebo pills will be administered to individuals randomized to metformin only in order to maintain study blinding.
Metformin + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
OCP + Metformin
n=80 Participants
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg.
OCP + Metformin: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
|---|---|---|---|
|
Changes in Total Body Fat Distribution in the 3 Arms From Baseline to 6 Months
|
-0.83 kg
Interval -1.65 to -0.01
|
-0.48 kg
Interval -1.24 to 0.28
|
0.06 kg
Interval -0.7 to 0.82
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsThis will be measured by NMR spectroscopy
Outcome measures
| Measure |
OCP + Placebo
n=79 Participants
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Placebo pills will be administered to individuals randomized to OCP only in order to maintain study blinding.
OCP + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
Metformin + Placebo
n=81 Participants
Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. Placebo pills will be administered to individuals randomized to metformin only in order to maintain study blinding.
Metformin + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
OCP + Metformin
n=80 Participants
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg.
OCP + Metformin: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
|---|---|---|---|
|
Changes in Total Triglyceride-Rich Lipoprotein (TRLP) From Baseline to 6 Months
|
-2.26 mol/L
Interval -0.02 to 0.06
|
6.33 mol/L
Interval -5.35 to 18.02
|
10.24 mol/L
Interval -1.7 to 22.18
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Uses all available data, Intent to Treat
Measured by change in Free Fatty Acids
Outcome measures
| Measure |
OCP + Placebo
n=79 Participants
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Placebo pills will be administered to individuals randomized to OCP only in order to maintain study blinding.
OCP + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
Metformin + Placebo
n=81 Participants
Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. Placebo pills will be administered to individuals randomized to metformin only in order to maintain study blinding.
Metformin + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
OCP + Metformin
n=80 Participants
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg.
OCP + Metformin: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
|---|---|---|---|
|
Changes in Serum Marker of Inflammation: Free Fatty Acids.
|
0.04 mEq/L
Interval -0.02 to 0.1
|
-0.03 mEq/L
Interval -0.09 to 0.03
|
0.09 mEq/L
Interval 0.03 to 0.15
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Uses all available data, Intent to Treat
QOL will be measured by the Polycystic Ovary Syndrome Questionnaire (PCOSQ) Body Hair domain which has 5 items rated on a 7 point likert scale with a lower score representing a decreased quality of life. The total range is 7 to 35.
Outcome measures
| Measure |
OCP + Placebo
n=79 Participants
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Placebo pills will be administered to individuals randomized to OCP only in order to maintain study blinding.
OCP + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
Metformin + Placebo
n=81 Participants
Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. Placebo pills will be administered to individuals randomized to metformin only in order to maintain study blinding.
Metformin + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
OCP + Metformin
n=80 Participants
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg.
OCP + Metformin: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
|---|---|---|---|
|
Changes in Quality of Life Parameters for Body Hair in All 3 Arms as Assessed by PCOSQ From Baseline to 6 Months
|
0.74 score on a scale
Interval 0.46 to 1.02
|
0.26 score on a scale
Interval -0.01 to 0.53
|
0.62 score on a scale
Interval 0.35 to 0.9
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Uses all available data, Intent to Treat
Body fat distribution will be measured by DXA. These changes will be correlated with changes in serum and androgens and markers of insulin sensitivity
Outcome measures
| Measure |
OCP + Placebo
n=79 Participants
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Placebo pills will be administered to individuals randomized to OCP only in order to maintain study blinding.
OCP + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
Metformin + Placebo
n=81 Participants
Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. Placebo pills will be administered to individuals randomized to metformin only in order to maintain study blinding.
Metformin + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
OCP + Metformin
n=80 Participants
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg.
OCP + Metformin: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
|---|---|---|---|
|
Changes in Visceral Body Fat Distribution in the 3 Arms
|
-167 g
Interval -264.0 to -71.0
|
-86 g
Interval -176.0 to 4.0
|
-58 g
Interval -148.0 to 32.0
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Uses all available data, Intent to Treat
QOL will be measured by the Polycystic Ovary Syndrome Questionnaire (PCOSQ) Weight domain which has 5 items rated on a 7 point likert scale with a lower score representing a decreased quality of life. The total range is 7 to 35.
Outcome measures
| Measure |
OCP + Placebo
n=79 Participants
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Placebo pills will be administered to individuals randomized to OCP only in order to maintain study blinding.
OCP + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
Metformin + Placebo
n=81 Participants
Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. Placebo pills will be administered to individuals randomized to metformin only in order to maintain study blinding.
Metformin + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
OCP + Metformin
n=80 Participants
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg.
OCP + Metformin: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
|---|---|---|---|
|
Changes in Quality of Life Parameters for Weight in All 3 Arms as Assessed by PCOSQ From Baseline to 6 Months
|
0.72 score on a scale
Interval 0.37 to 1.07
|
0.34 score on a scale
Interval 0.01 to 0.68
|
0.62 score on a scale
Interval 0.35 to 0.9
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: The study team planned to complete this outcome, however, we did not have funding to complete the outcome and there is no plan to run this analysis in the future. Therefore we have no results to report, nor will we in the future.
This will be assessed by measuring reverse cholesterol efflux capacity using validated ex vivo system.
Outcome measures
Outcome data not reported
Adverse Events
OCP + Placebo
Serious events: 2 serious events
Other events: 71 other events
Deaths: 0 deaths
Metformin + Placebo
Serious events: 3 serious events
Other events: 76 other events
Deaths: 0 deaths
OCP + Metformin
Serious events: 3 serious events
Other events: 78 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OCP + Placebo
n=79 participants at risk
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Placebo pills will be administered to individuals randomized to OCP only in order to maintain study blinding.
OCP + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
Metformin + Placebo
n=81 participants at risk
Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. Placebo pills will be administered to individuals randomized to metformin only in order to maintain study blinding.
Metformin + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
OCP + Metformin
n=80 participants at risk
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg.
OCP + Metformin: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
|---|---|---|---|
|
Gastrointestinal disorders
Hospitalization
|
0.00%
0/79 • Adverse Event data was collected for 7 months.
|
0.00%
0/81 • Adverse Event data was collected for 7 months.
|
1.2%
1/80 • Number of events 1 • Adverse Event data was collected for 7 months.
|
|
Reproductive system and breast disorders
Surgical Intervention
|
1.3%
1/79 • Number of events 1 • Adverse Event data was collected for 7 months.
|
0.00%
0/81 • Adverse Event data was collected for 7 months.
|
0.00%
0/80 • Adverse Event data was collected for 7 months.
|
|
Psychiatric disorders
Hospitalization
|
0.00%
0/79 • Adverse Event data was collected for 7 months.
|
1.2%
1/81 • Number of events 1 • Adverse Event data was collected for 7 months.
|
0.00%
0/80 • Adverse Event data was collected for 7 months.
|
|
Pregnancy, puerperium and perinatal conditions
Hospitalization
|
0.00%
0/79 • Adverse Event data was collected for 7 months.
|
1.2%
1/81 • Number of events 1 • Adverse Event data was collected for 7 months.
|
0.00%
0/80 • Adverse Event data was collected for 7 months.
|
|
Reproductive system and breast disorders
Hospitalization
|
0.00%
0/79 • Adverse Event data was collected for 7 months.
|
1.2%
1/81 • Number of events 1 • Adverse Event data was collected for 7 months.
|
0.00%
0/80 • Adverse Event data was collected for 7 months.
|
|
Hepatobiliary disorders
Hospitalization
|
0.00%
0/79 • Adverse Event data was collected for 7 months.
|
0.00%
0/81 • Adverse Event data was collected for 7 months.
|
1.2%
1/80 • Number of events 1 • Adverse Event data was collected for 7 months.
|
|
Nervous system disorders
Medical intervention
|
0.00%
0/79 • Adverse Event data was collected for 7 months.
|
0.00%
0/81 • Adverse Event data was collected for 7 months.
|
1.2%
1/80 • Number of events 1 • Adverse Event data was collected for 7 months.
|
Other adverse events
| Measure |
OCP + Placebo
n=79 participants at risk
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Placebo pills will be administered to individuals randomized to OCP only in order to maintain study blinding.
OCP + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
Metformin + Placebo
n=81 participants at risk
Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. Placebo pills will be administered to individuals randomized to metformin only in order to maintain study blinding.
Metformin + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
OCP + Metformin
n=80 participants at risk
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg.
OCP + Metformin: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
34.2%
27/79 • Number of events 31 • Adverse Event data was collected for 7 months.
|
64.2%
52/81 • Number of events 78 • Adverse Event data was collected for 7 months.
|
65.0%
52/80 • Number of events 67 • Adverse Event data was collected for 7 months.
|
|
Gastrointestinal disorders
Nausea
|
36.7%
29/79 • Number of events 31 • Adverse Event data was collected for 7 months.
|
42.0%
34/81 • Number of events 42 • Adverse Event data was collected for 7 months.
|
46.2%
37/80 • Number of events 44 • Adverse Event data was collected for 7 months.
|
|
Gastrointestinal disorders
Abdominal Pain/Cramping
|
12.7%
10/79 • Number of events 11 • Adverse Event data was collected for 7 months.
|
33.3%
27/81 • Number of events 30 • Adverse Event data was collected for 7 months.
|
25.0%
20/80 • Number of events 22 • Adverse Event data was collected for 7 months.
|
|
Gastrointestinal disorders
Vomiting
|
10.1%
8/79 • Number of events 8 • Adverse Event data was collected for 7 months.
|
24.7%
20/81 • Number of events 21 • Adverse Event data was collected for 7 months.
|
22.5%
18/80 • Number of events 21 • Adverse Event data was collected for 7 months.
|
|
Gastrointestinal disorders
Abdominal Bloating
|
12.7%
10/79 • Number of events 11 • Adverse Event data was collected for 7 months.
|
11.1%
9/81 • Number of events 10 • Adverse Event data was collected for 7 months.
|
11.2%
9/80 • Number of events 9 • Adverse Event data was collected for 7 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
4/79 • Number of events 4 • Adverse Event data was collected for 7 months.
|
6.2%
5/81 • Number of events 7 • Adverse Event data was collected for 7 months.
|
15.0%
12/80 • Number of events 12 • Adverse Event data was collected for 7 months.
|
|
Gastrointestinal disorders
Decreased Appetite
|
3.8%
3/79 • Number of events 3 • Adverse Event data was collected for 7 months.
|
3.7%
3/81 • Number of events 4 • Adverse Event data was collected for 7 months.
|
8.8%
7/80 • Number of events 7 • Adverse Event data was collected for 7 months.
|
|
Gastrointestinal disorders
Flatulence
|
7.6%
6/79 • Number of events 6 • Adverse Event data was collected for 7 months.
|
11.1%
9/81 • Number of events 9 • Adverse Event data was collected for 7 months.
|
5.0%
4/80 • Number of events 4 • Adverse Event data was collected for 7 months.
|
|
Reproductive system and breast disorders
Vaginal Bleeding/Spotting
|
24.1%
19/79 • Number of events 22 • Adverse Event data was collected for 7 months.
|
2.5%
2/81 • Number of events 3 • Adverse Event data was collected for 7 months.
|
8.8%
7/80 • Number of events 8 • Adverse Event data was collected for 7 months.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
19.0%
15/79 • Number of events 21 • Adverse Event data was collected for 7 months.
|
11.1%
9/81 • Number of events 14 • Adverse Event data was collected for 7 months.
|
13.8%
11/80 • Number of events 12 • Adverse Event data was collected for 7 months.
|
|
Reproductive system and breast disorders
Breast Symptoms
|
8.9%
7/79 • Number of events 9 • Adverse Event data was collected for 7 months.
|
2.5%
2/81 • Number of events 2 • Adverse Event data was collected for 7 months.
|
6.2%
5/80 • Number of events 8 • Adverse Event data was collected for 7 months.
|
|
Nervous system disorders
Dizziness
|
3.8%
3/79 • Number of events 3 • Adverse Event data was collected for 7 months.
|
7.4%
6/81 • Number of events 8 • Adverse Event data was collected for 7 months.
|
5.0%
4/80 • Number of events 4 • Adverse Event data was collected for 7 months.
|
|
Nervous system disorders
Headache/Migraine
|
26.6%
21/79 • Number of events 44 • Adverse Event data was collected for 7 months.
|
25.9%
21/81 • Number of events 34 • Adverse Event data was collected for 7 months.
|
26.2%
21/80 • Number of events 27 • Adverse Event data was collected for 7 months.
|
|
Psychiatric disorders
Mood Swings/Depression
|
12.7%
10/79 • Number of events 11 • Adverse Event data was collected for 7 months.
|
3.7%
3/81 • Number of events 3 • Adverse Event data was collected for 7 months.
|
3.8%
3/80 • Number of events 3 • Adverse Event data was collected for 7 months.
|
|
Musculoskeletal and connective tissue disorders
Joint/muscle pain
|
5.1%
4/79 • Number of events 4 • Adverse Event data was collected for 7 months.
|
6.2%
5/81 • Number of events 5 • Adverse Event data was collected for 7 months.
|
3.8%
3/80 • Number of events 3 • Adverse Event data was collected for 7 months.
|
|
Infections and infestations
Upper Respiratory Infection
|
20.3%
16/79 • Number of events 16 • Adverse Event data was collected for 7 months.
|
17.3%
14/81 • Number of events 16 • Adverse Event data was collected for 7 months.
|
10.0%
8/80 • Number of events 8 • Adverse Event data was collected for 7 months.
|
|
Infections and infestations
COVID infection/symptoms after exposure
|
8.9%
7/79 • Number of events 7 • Adverse Event data was collected for 7 months.
|
3.7%
3/81 • Number of events 3 • Adverse Event data was collected for 7 months.
|
5.0%
4/80 • Number of events 4 • Adverse Event data was collected for 7 months.
|
|
General disorders
Fatigue
|
5.1%
4/79 • Number of events 4 • Adverse Event data was collected for 7 months.
|
11.1%
9/81 • Number of events 9 • Adverse Event data was collected for 7 months.
|
7.5%
6/80 • Number of events 6 • Adverse Event data was collected for 7 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place