Condition category
Urological and Genital Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
23/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr AH Balen

ORCID ID

Contact details

IVF Unit
C Floor
Clarendon Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 2728
adam.balen@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436043817

Study information

Scientific title

Acronym

Study hypothesis

To compare the efficacy of metformin in the management of anovulatory women with PCOS.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Anovulatory polycystic ovary syndrome (PCOS)

Intervention

Randomised controlled trial. Random allocation to:
1. Metformin
2. Placebo

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Pregnancy/ovulation

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/1999

Overall trial end date

01/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Overweight women with PCOS.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/04/1999

Recruitment end date

01/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

IVF Unit
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16199429

Publication citations

  1. Results

    Tang T, Glanville J, Hayden CJ, White D, Barth JH, Balen AH, Combined lifestyle modification and metformin in obese patients with polycystic ovary syndrome. A randomized, placebo-controlled, double-blind multicentre study., Hum. Reprod., 2006, 21, 1, 80-89, doi: 10.1093/humrep/dei311.

Additional files

Editorial Notes