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Trial · NCT03117517

Treatment With Metformin and Combination of Metformin and Pioglitazone in Polycystic Ovarian Syndrome

NCT03117517, Early phase 1, Completed, Khyber Medical University Peshawar; results first posted 2020-03-02

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Treatment With Metformin and Combination of Metformin and Pioglitazone in Polycystic Ovarian Syndrome. Trials, record NCT03117517. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03117517

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Trial

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

Title
Treatment With Metformin and Combination of Metformin and Pioglitazone in Polycystic Ovarian Syndrome
NCT number
NCT03117517
Status
Completed
Phases
Early phase 1
Enrollment
106 participants, actual
Lead sponsor
Khyber Medical University Peshawar
Conditions
Polycystic Ovarian Syndrome
Interventions
Metformin, Metformin, Pioglitazone
First posted
2017-04-18
Last updated
2020-03-02
Results first posted
2020-03-02
Limitations and caveats
No blinding No measure of visceral adiposity.

Source ClinicalTrials.gov

Registered outcomes3

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

ListOutcomeTime frameDescription
PrimaryCytokines and Chemokines MeasurementsBaseline and after 3 MonthsIL-6 and IL-8 levels by ELISA method using commercially available kits.
SecondaryHormonal ProfilesBaseine and after 3 MonthsSerum level of LH was measure at baseline and after 3 months of treatment
SecondaryInsulin ResistanceBaseline and after 3 monthsInsulin resistance was measure by calculating HOMA-IR from the data of insulin and sugar levels.

Outcomes3

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYCytokines and Chemokines MeasurementsBaseline and after 3 MonthsMeasurement of IL-6 levels in serum samples at baseline and after 3 months of treatmentpg/mlGEOMETRIC_MEAN
SECONDARYHormonal ProfilesBaseine and after 3 MonthsSerum LH level at baslinemIU/mlGEOMETRIC_MEAN
SECONDARYInsulin ResistanceBaseline and after 3 monthsInsulin resistance was determined by HOMA-IRunitlessMEAN

Results by group16

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

OutcomeGroupCategoryValueSpreadUnits
Cytokines and Chemokines MeasurementsMetforminIL-6 levels at baseline14.6095% Confidence Interval 12.05 to 17.69pg/ml
Cytokines and Chemokines MeasurementsMetformin, PioglitazoneIL-6 levels at baseline14.1295% Confidence Interval 11.58 to 17.23pg/ml
Cytokines and Chemokines MeasurementsMetforminIL-6 levels after 3 months of treatment12.6595% Confidence Interval 10.61 to 15.08pg/ml
Cytokines and Chemokines MeasurementsMetformin, PioglitazoneIL-6 levels after 3 months of treatment11.1295% Confidence Interval 10.02 to 12.33pg/ml
Cytokines and Chemokines MeasurementsMetforminIL-8 Llevels at baseline61.9295% Confidence Interval 52.95 to 72.41pg/ml
Cytokines and Chemokines MeasurementsMetformin, PioglitazoneIL-8 Llevels at baseline41.8695% Confidence Interval 38.24 to 45.83pg/ml
Cytokines and Chemokines MeasurementsMetforminIL-8 Llevels after treatment32.7095% Confidence Interval 22.99 to 46.50pg/ml
Cytokines and Chemokines MeasurementsMetformin, PioglitazoneIL-8 Llevels after treatment22.0095% Confidence Interval 16.76 to 28.88pg/ml
Hormonal ProfilesMetforminLH level at baseline5.7995% Confidence Interval 4.95 to 6.77mIU/ml
Hormonal ProfilesMetformin, PioglitazoneLH level at baseline6.62595% Confidence Interval 5.52 to 7.94mIU/ml

Participant flow6

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDMetformin53
Overall StudySTARTEDMetformin, Pioglitazone53
Overall StudyCOMPLETEDMetformin48
Overall StudyCOMPLETEDMetformin, Pioglitazone49
Overall StudyNOT COMPLETEDMetformin5
Overall StudyNOT COMPLETEDMetformin, Pioglitazone4

Adverse events0

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

None in this release.

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityMetformin00
Total, all-cause mortalityMetformin, Pioglitazone00
Total, other adverse eventsMetformin00
Total, other adverse eventsMetformin, Pioglitazone00
Total, serious adverse eventsMetformin00
Total, serious adverse eventsMetformin, Pioglitazone00

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
8177055RESULTPubMed
15598674BACKGROUNDPubMed
24873996RESULTPubMed
25096410RESULTPubMed
26849353BACKGROUNDPubMed

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 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/NCT03117517

GET https://conductscience.org/api/trials/v1/NCT03117517/registered