NCT00501787

Brief Summary

In a recent prospective study evaluating the efficacy of 1700 mg/day metformin as first-line approach for infertile anovulatory patients with PCOS, we identified predictors for metformin efficacy. Our analysis demonstrated that body mass index (BMI) and insulin resistance were the strongest predictors for both ovulation and pregnancy. In particular, adjusting the data for insulin resistance, a trend in reduced effectiveness was observed with increasing BMI. On the other hand, adjusting the data for BMI, a trend in improved efficacy was detected for higher insulin resistance degrees. To date, no dose-finding study is currently available in literature evaluating the best dose of metformin to administer. In addition, very few data regarding the best protocol for metformin treatment also are available. However, in order to reduce drug-related side effects incidence due to start-up syndrome, metformin is generally administrated with meals at incremental weekly doses until the maximum dosage ranging from 500 to 2550 mg daily; the doses are reduced if side effects appear. This commonly accepted protocol has not been supported by scientific evidences. The aim of the present study will be to evaluate in a clinical setting the compliance, the safety and the effectiveness of two schedules for metformin administration in infertile anovulatory PCOS patients.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Last Updated

April 9, 2013

Status Verified

April 1, 2013

Enrollment Period

4.8 years

First QC Date

July 12, 2007

Last Update Submit

April 5, 2013

Conditions

Polycystic Ovary Syndrome

Keywords

AnovulationmetforminPCOStreatment

Outcome Measures

Primary Outcomes (1)

  • Ovulation rate

Secondary Outcomes (5)

  • Adverse events

  • Adherence rate

  • Pregnancy rate

  • Abortion rate

  • Live-birth rate

Study Arms (2)

Group B

ACTIVE COMPARATOR

Non-tailoring

Drug: Metformin

Group A

ACTIVE COMPARATOR

Tailoring

Drug: Metformin

Interventions

MetforminDRUG
Group AGroup B

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Age GroupsAdult (18-64)

You may qualify if:

  • Polycystic ovary syndrome (using NIH criteria)
  • Anovulatory infertility (using WHO criteria)

You may not qualify if:

  • Age \<18 or \>35 years
  • Severe obesity (BMI \>35)
  • Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses
  • Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti-obesity drugs or other hormonal drugs
  • Previous use of ovulation induction agents
  • Intention to start a diet or a specific program of physical activity
  • Organic pelvic diseases
  • Previous pelvic surgery
  • Suspected peritoneal factor infertility
  • Tubal or male factor infertility or sub-fertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pugliese Hospital

Catanzaro, Catanzaro, CZ, 88100, Italy

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeAnovulation

Interventions

Metformin

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 Chemicals

Study Officials

  • Stefano Palomba, MD

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

    PRINCIPAL INVESTIGATOR

  • Francesco Orio, MD

    Department of Endocrinology, University "Federico II" of Naples

    PRINCIPAL INVESTIGATOR

  • Achille Tolino, MD

    Department of Obstetrics & Gynecology, University "Federico II" of Naples

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 12, 2007

First Posted

July 16, 2007

Study Start

January 1, 2008

Primary Completion

October 1, 2012

Last Updated

April 9, 2013

Record last verified: 2013-04

Locations

IT(1)