MedTrace Logo

PCOSMIC Trial - PolyCystic Ovary Syndrome, Metformin for Infertility With Clomiphene

NCT00795808 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2008-11-21

No results posted yet for this study

Summary

1. Metformin increases the pregnancy rate when added to the standard treatment of anovulatory polycystic ovary syndrome (PCOS).
2. Metformin in combination with clomiphene, is more effective than clomiphene alone or metformin alone improves fertility outcomes in women with PCOS of reasonably healthy body weight (BMI \</= 32).
3. Metformin improves fertility outcomes in women with BMI \> 32 with PCOS.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

Metformin

500mg tds for 6 months

DRUG

Placebo

One tablet tds for 6 months

DRUG

Metformin + Clomiphene

500mg tds + Ovulatory dose for 6 months

DRUG

Metformin

500mg tds for 6 months

DRUG

Clomiphene

Ovulatory dose for 6 months

Sponsors & Collaborators

  • Auckland Medical Research Foundation

    collaborator OTHER

  • Mercia Barnes Trust of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists

    collaborator OTHER

  • University of Auckland, New Zealand

    lead OTHER

Principal Investigators

  • Neil P Johnson, FRANZCOG · University of Auckland, fertility Plus & Repromed Auckland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00795808 on ClinicalTrials.gov