NCT01115140

Brief Summary

A more recent prospective nonrandomized placebo-controlled double-blind clinical study demonstrated that metformin exerts a slight but significant deleterious effect on serum homocysteine (Hcy) levels in patients with PCOS, and supplementation with folate is useful to increase the beneficial effect of metformin on the vascular endothelium.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_4 pregnancy

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_4 pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 24, 2011

Status Verified

May 1, 2011

Enrollment Period

1.2 years

First QC Date

May 3, 2010

Last Update Submit

May 23, 2011

Conditions

PregnancyPolycystic Ovary Syndrome

Keywords

FolateMetforminPCOSPregnancyTrophoblastic invasionUterine artery velocimetry

Outcome Measures

Primary Outcomes (1)

  • Trophoblastic invasion.

    Istologic evaluation of trophoblastic ivasion,

    two weeks

Secondary Outcomes (1)

  • Doppler velocimetry measurements of the uterine artery.

    two weeks

Study Arms (5)

Group A1

ACTIVE COMPARATOR

metformin plus placebo

Drug: metformin plus placebo

Group A2

EXPERIMENTAL

metformin plus folic acid

Drug: Metformin plus folic acid

Group A3

ACTIVE COMPARATOR

placebo plus folic acid

Drug: placebo plus folic acid

Group A4

PLACEBO COMPARATOR

placebo cp, 2 cps daily

Drug: placebo alone

Group B

NO INTERVENTION

observation

Interventions

metformin plus placeboDRUG

metformin 850 mg cp, 2 cps daily

Group A1
Metformin plus folic acidDRUG

metformin 850 mg cp, 2 cps daily plus folic acid 0.4 mg daily

Group A2
placebo plus folic acidDRUG

Placebo 1 cp daily plus folic acid 0.4 mg daily

Group A3
placebo aloneDRUG

placebo cp, 2 cps daily

Group A4

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnancy
  • PCOS

You may not qualify if:

  • Risk factors for pregnancy complications
  • Severe obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Pugliese" Hospital

Catanzaro, Catanzaro, 88100, Italy

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

MetforminFolic Acid

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Fulvio Zullo, MD

    Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

    STUDY CHAIR

  • Stefano Palomba, MD

    Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2010

First Posted

May 4, 2010

Study Start

March 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 24, 2011

Record last verified: 2011-05

Locations

IT(1)