NCT00471523

Brief Summary

Clomiphene citrate (CC) and metformin are two effective drugs used to induce ovulation in patients with polycystic ovary syndrome (PCOS), even if it is still unclear which compound between them should be initially administered. The aim of the study will be to compare in a clinical setting the efficacy of CC and metformin as first-line approaches for treating anovulation in infertile PCOS patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2006

Shorter than P25 for phase_4

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

May 1, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2007

Completed
Last Updated

May 10, 2007

Status Verified

May 1, 2007

First QC Date

May 8, 2007

Last Update Submit

May 8, 2007

Conditions

InfertilityPolycystic Ovary SyndromeAnovulation

Keywords

AnovulationClomiphene citrateInfertilityMetforminPCOSTreatment

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    10 months

Secondary Outcomes (5)

  • Ovulation rate

    6 months

  • Abortion rate

    10 months

  • Time to first pregnancy

    10 months

  • Adverse events

    10 months

  • N. pregnancies/n. ovulatory cycles

    10 months

Interventions

Clomiphene citrateDRUG
MetforminDRUG

Eligibility Criteria

Age18 Years - 41 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Anovulatory infertility related to polycystic ovary syndrome

You may not qualify if:

  • 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, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.
  • 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, CZ, 88100, Italy

Location

Related Publications (5)

  • Palomba S, Orio F Jr, Falbo A, Manguso F, Russo T, Cascella T, Tolino A, Carmina E, Colao A, Zullo F. Prospective parallel randomized, double-blind, double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first-line treatment for ovulation induction in nonobese anovulatory women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Jul;90(7):4068-74. doi: 10.1210/jc.2005-0110. Epub 2005 Apr 19.

    PMID: 15840746BACKGROUND

  • Palomba S, Orio F Jr, Falbo A, Russo T, Tolino A, Zullo F. Effects of metformin and clomiphene citrate on ovarian vascularity in patients with polycystic ovary syndrome. Fertil Steril. 2006 Dec;86(6):1694-701. doi: 10.1016/j.fertnstert.2006.05.035. Epub 2006 Oct 30.

    PMID: 17074337BACKGROUND

  • Palomba S, Orio F, Zullo F. Ovulation induction in women with polycystic ovary syndrome. Fertil Steril. 2006 Jul;86 Suppl 1:S26-7. doi: 10.1016/j.fertnstert.2006.03.018.

    PMID: 16798282BACKGROUND

  • Palomba S, Russo T, Orio F Jr, Falbo A, Manguso F, Sammartino A, Tolino A, Colao A, Carmina E, Zullo F. Uterine effects of clomiphene citrate in women with polycystic ovary syndrome: a prospective controlled study. Hum Reprod. 2006 Nov;21(11):2823-9. doi: 10.1093/humrep/del267. Epub 2006 Jul 10.

    PMID: 16835214BACKGROUND

  • Palomba S, Falbo A, Orio F Jr, Tolino A, Zullo F. Efficacy predictors for metformin and clomiphene citrate treatment in anovulatory infertile patients with polycystic ovary syndrome. Fertil Steril. 2009 Jun;91(6):2557-67. doi: 10.1016/j.fertnstert.2008.03.011. Epub 2008 Apr 28.

    PMID: 18440534DERIVED

MeSH Terms

Conditions

InfertilityPolycystic Ovary SyndromeAnovulation

Interventions

ClomipheneMetformin

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBiguanidesGuanidinesAmidines

Study Officials

  • Stefano Palomba, MD

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

    PRINCIPAL INVESTIGATOR

  • Achille Tolino, MD

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

    PRINCIPAL INVESTIGATOR

  • Francesco Orio, MD

    Department of Endocrinology, University "Federico II" of Naples

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 8, 2007

First Posted

May 10, 2007

Study Start

May 1, 2006

Study Completion

March 1, 2007

Last Updated

May 10, 2007

Record last verified: 2007-05

Locations

IT(1)