Trial · NCT00151411

Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)

NCT00151411, Phase 2, Completed, Milton S. Hershey Medical Center; results first posted 2011-11-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS). Trials, record NCT00151411. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00151411

On this page

Trial

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

Title: Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)
NCT number: NCT00151411
Status: Completed
Phases: Phase 2
Enrollment: 114 participants, actual
Lead sponsor: Milton S. Hershey Medical Center
Conditions: Polycystic Ovary Syndrome
Interventions: Metformin, Placebo, Lifestyle Intervention
First posted: 2005-09-09
Last updated: 2018-03-21
Results first posted: 2011-11-08

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Change in Testosterone After 6 Months of Treatment	baseline and 6 months
Secondary	Ovulation Rate	6 months	Count of ovulations per subject during the treatment period.
Secondary	Change in Insulin Sensitivity Index After 6 Months of Treatment	baseline and 6 months

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Testosterone After 6 Months of Treatment	baseline and 6 months		ng/dL	LEAST_SQUARES_MEAN
SECONDARY	Ovulation Rate	6 months	A total of 76 patients with daily urine collections.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Insulin Sensitivity Index After 6 Months of Treatment	baseline and 6 months		index	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group18

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

Outcome	Group	Category	Value	Spread	Units
Change in Testosterone After 6 Months of Treatment	Metformin		-2.1	95% Confidence Interval -12.1 to 7.9	ng/dL
Change in Testosterone After 6 Months of Treatment	Placebo		-6.4	95% Confidence Interval -16.9 to 4.1	ng/dL
Ovulation Rate	Metformin	0 ovulations	10		Participants
Ovulation Rate	Placebo	0 ovulations	19		Participants
Ovulation Rate	Metformin	1 ovulation	6		Participants
Ovulation Rate	Placebo	1 ovulation	5		Participants
Ovulation Rate	Metformin	2 ovulations	4		Participants
Ovulation Rate	Placebo	2 ovulations	7		Participants
Ovulation Rate	Metformin	3 ovulations	7		Participants
Ovulation Rate	Placebo	3 ovulations	3		Participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Metformin	55
Overall Study	STARTED	Placebo	59
Overall Study	COMPLETED	Metformin	22
Overall Study	COMPLETED	Placebo	16
Overall Study	NOT COMPLETED	Metformin	33
Overall Study	NOT COMPLETED	Placebo	43

Source ClinicalTrials.gov

Adverse events34

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	Metformin	19	55	78
other	Diarrhea	Gastrointestinal disorders	Placebo	6	59	22
other	stomach/abdominal pain or discomfort	Gastrointestinal disorders	Metformin	6	55	9
other	stomach/abdominal pain or discomfort	Gastrointestinal disorders	Placebo	7	59	16
other	nausea and/or vomiting	Gastrointestinal disorders	Metformin	9	55	27
other	nausea and/or vomiting	Gastrointestinal disorders	Placebo	7	59	18
other	flatulence	Gastrointestinal disorders	Metformin	2	55	5
other	flatulence	Gastrointestinal disorders	Placebo	3	59	3
other	flu	Gastrointestinal disorders	Metformin	8	55	12
other	flu	Gastrointestinal disorders	Placebo	4	59	4

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Metformin
Total, all-cause mortality	Placebo
Total, other adverse events	Metformin	38	55
Total, other adverse events	Placebo	33	59
Total, serious adverse events	Metformin	0	55
Total, serious adverse events	Placebo	0	59

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21193187	DERIVED	PubMed
21704212	DERIVED	PubMed

Grants0

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.

None in this release.

Trial comparisons1

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

Comparison
Metformin vs Placebo: serious adverse events

Source Trial comparisons

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/NCT00151411

GET https://conductscience.org/api/trials/v1/NCT00151411/events?page=2

API reference For AI assistants