Trial · NCT03229057

Comparing the Effects of Oral Contraceptive Pills Versus Metformin

NCT03229057, Phase 3, Completed, Anuja Dokras; results first posted 2025-03-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparing the Effects of Oral Contraceptive Pills Versus Metformin. Trials, record NCT03229057. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03229057

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Comparing the Effects of Oral Contraceptive Pills Versus Metformin
NCT number: NCT03229057
Status: Completed
Phases: Phase 3
Enrollment: 240 participants, actual
Lead sponsor: Anuja Dokras
Conditions: PCOS
Interventions: OCP + Metformin, OCP + Placebo, Metformin + Placebo
First posted: 2017-07-25
Last updated: 2025-11-05
Results first posted: 2025-03-10
Limitations and caveats: Two outcomes, Changes in HDL-C function assessed by measuring reverse cholesterol efflux capacity using validated ex vivo system and serum adipokines which are to be measured are adiponectin and leptin. We are currently looking for a vendor to run these assays.

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Metabolic Syndrome After 6 Months of Treatment Metformin or OCP+Metformin for 6 Months.	Baseline and 6 months	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)
Secondary	Changes in Serum Apoliprotein B From Baseline to 6 Months	Baseline and 6 months	This will be measured by NMR spectroscopy
Secondary	Changes in Serum Adipokines in the 3 Arms	Baseline and 6 months	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.
Secondary	Changes in Total Body Fat Distribution in the 3 Arms From Baseline to 6 Months	Baseline and 6 months	Body fat distribution will be measured by DXA. These changes will be correlated with changes in serum and androgens and markers of insulin sensitivity
Secondary	Changes in Total Triglyceride-Rich Lipoprotein (TRLP) From Baseline to 6 Months	Baseline and 6 months	This will be measured by NMR spectroscopy
Secondary	Changes in Serum Marker of Inflammation: Free Fatty Acids.	Baseline and 6 months	Measured by change in Free Fatty Acids
Secondary	Changes in Quality of Life Parameters for Body Hair in All 3 Arms as Assessed by PCOSQ From Baseline to 6 Months	Baseline and 6 months	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.
Secondary	Changes in Visceral Body Fat Distribution in the 3 Arms	Baseline and 6 months	Body fat distribution will be measured by DXA. These changes will be correlated with changes in serum and androgens and markers of insulin sensitivity
Secondary	Changes in Quality of Life Parameters for Weight in All 3 Arms as Assessed by PCOSQ From Baseline to 6 Months	Baseline and 6 months	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.
Secondary	Change in HDL-C Function	Baseline and 6 months	This will be assessed by measuring reverse cholesterol efflux capacity using validated ex vivo system.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Metabolic Syndrome After 6 Months of Treatment Metformin or OCP+Metformin for 6 Months.	Baseline and 6 months	Includes all participants who completed an end of study visit greater than or equal to 16 weeks.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Changes in Serum Apoliprotein B From Baseline to 6 Months	Baseline and 6 months	Uses all available data, Intent to Treat	g/L	MEAN
SECONDARY	Changes in Serum Adipokines in the 3 Arms	Baseline and 6 months	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.
SECONDARY	Changes in Total Body Fat Distribution in the 3 Arms From Baseline to 6 Months	Baseline and 6 months	Uses all available data, Intent to Treat	kg	MEAN
SECONDARY	Changes in Total Triglyceride-Rich Lipoprotein (TRLP) From Baseline to 6 Months	Baseline and 6 months		mol/L	MEAN
SECONDARY	Changes in Serum Marker of Inflammation: Free Fatty Acids.	Baseline and 6 months	Uses all available data, Intent to Treat	mEq/L	MEAN
SECONDARY	Changes in Quality of Life Parameters for Body Hair in All 3 Arms as Assessed by PCOSQ From Baseline to 6 Months	Baseline and 6 months	Uses all available data, Intent to Treat	score on a scale	MEAN
SECONDARY	Changes in Visceral Body Fat Distribution in the 3 Arms	Baseline and 6 months	Uses all available data, Intent to Treat	g	MEAN
SECONDARY	Changes in Quality of Life Parameters for Weight in All 3 Arms as Assessed by PCOSQ From Baseline to 6 Months	Baseline and 6 months	Uses all available data, Intent to Treat	score on a scale	MEAN
SECONDARY	Change in HDL-C Function	Baseline and 6 months	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.

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Participants With Metabolic Syndrome After 6 Months of Treatment Metformin or OCP+Metformin for 6 Months.	OCP + Placebo	17		Participants
Number of Participants With Metabolic Syndrome After 6 Months of Treatment Metformin or OCP+Metformin for 6 Months.	Metformin + Placebo	17		Participants
Number of Participants With Metabolic Syndrome After 6 Months of Treatment Metformin or OCP+Metformin for 6 Months.	OCP + Metformin	18		Participants
Changes in Serum Apoliprotein B From Baseline to 6 Months	OCP + Placebo	.03	Inter-Quartile Range -0.02 to 0.06	g/L
Changes in Serum Apoliprotein B From Baseline to 6 Months	Metformin + Placebo	0.003	Inter-Quartile Range -0.03 to 0.04	g/L
Changes in Serum Apoliprotein B From Baseline to 6 Months	OCP + Metformin	0.05	Inter-Quartile Range 0.01 to 0.09	g/L
Changes in Total Body Fat Distribution in the 3 Arms From Baseline to 6 Months	OCP + Placebo	-0.83	Inter-Quartile Range -1.65 to -0.01	kg
Changes in Total Body Fat Distribution in the 3 Arms From Baseline to 6 Months	Metformin + Placebo	-0.48	Inter-Quartile Range -1.24 to 0.28	kg
Changes in Total Body Fat Distribution in the 3 Arms From Baseline to 6 Months	OCP + Metformin	0.06	Inter-Quartile Range -0.70 to 0.82	kg
Changes in Total Triglyceride-Rich Lipoprotein (TRLP) From Baseline to 6 Months	OCP + Placebo	-2.26	Inter-Quartile Range -0.02 to 0.06	mol/L

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	OCP + Placebo	79
Overall Study	STARTED	Metformin + Placebo	81
Overall Study	STARTED	OCP + Metformin	80
Overall Study	End of study outcome	OCP + Placebo	59
Overall Study	End of study outcome	Metformin + Placebo	65
Overall Study	End of study outcome	OCP + Metformin	63
Overall Study	COMPLETED	OCP + Placebo	52
Overall Study	COMPLETED	Metformin + Placebo	60
Overall Study	COMPLETED	OCP + Metformin	57
Overall Study	NOT COMPLETED	OCP + Placebo	27

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events78

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhea	Gastrointestinal disorders	OCP + Placebo	27	79	31
other	Diarrhea	Gastrointestinal disorders	Metformin + Placebo	52	81	78
other	Diarrhea	Gastrointestinal disorders	OCP + Metformin	52	80	67
other	Nausea	Gastrointestinal disorders	OCP + Placebo	29	79	31
other	Nausea	Gastrointestinal disorders	Metformin + Placebo	34	81	42
other	Nausea	Gastrointestinal disorders	OCP + Metformin	37	80	44
other	Abdominal Pain/Cramping	Gastrointestinal disorders	OCP + Placebo	10	79	11
other	Abdominal Pain/Cramping	Gastrointestinal disorders	Metformin + Placebo	27	81	30
other	Abdominal Pain/Cramping	Gastrointestinal disorders	OCP + Metformin	20	80	22
other	Vomiting	Gastrointestinal disorders	OCP + Placebo	8	79	8

1 to 10 of 78Source ClinicalTrials.gov

See all 78 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	OCP + Placebo	0	79
Total, all-cause mortality	Metformin + Placebo	0	81
Total, all-cause mortality	OCP + Metformin	0	80
Total, other adverse events	OCP + Placebo	71	79
Total, other adverse events	Metformin + Placebo	76	81
Total, other adverse events	OCP + Metformin	78	80
Total, serious adverse events	OCP + Placebo	2	79
Total, serious adverse events	Metformin + Placebo	3	81
Total, serious adverse events	OCP + Metformin	3	80

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
41359669	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HD091350	The COMET-PCOS trial - Comparing the effects of Oral Contraceptive Pills versus Metformin in the medical management of overweight/obese women with Polycystic Ovary Syndrome	DOKRAS, ANUJA	UNIVERSITY OF PENNSYLVANIA	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2017 to 2021

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03229057

GET https://conductscience.org/api/trials/v1/NCT03229057/results?page=2

API reference For AI assistants