Condition category
Urological and Genital Diseases
Date applied
17/11/2005
Date assigned
09/01/2006
Last edited
19/12/2007
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

Prof Lourdes Ibanez

ORCID ID

Contact details

Hospital Sant Joan de Deu
University of Barcelona
Passeig de Sant Joan de Deu
2
Esplugues
08950
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HSJD-LIT-05

Study information

Scientific title

Acronym

Study hypothesis

Hypothesis for the protocol extension added as of 05/07/2007:
Therapy for three years with pioglitazone, metformin and flutamide will reverse the endocrine-metabolic and body composition abnormalities in young women with androgen excess.

Previous hypothesis:
The addition of low-dose pioglitazone to combined flutamide-metformin therapy will result in significant improvements in the endocrine-metabolic and body composition abnormalities associated with hyperandrogenic hyperinsulinism in young women with increased cardiovascular risk.

Ethics approval

Ethics approval was received on the 5th November 2005; extensions approved on the 27th October 2006.

Study design

Double-blind, prospective, randomised, trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Ovarian hyperandrogenism with hyperinsulinism, dyslipemia and cardiovascular risk

Intervention

Please note that, as of 5 July 2007, the anticipated end date of this trial has been extended from 18 July 2006 to 31 December 2008.

Interventions for the protocol extension added as of 05/07/2007:
Over the last 18 months, patients will be randomised to receive for six months:
1. Pioglitazone, metformin and flutamide
2. Pioglitazone, metformin and placebo
3. Placebo, metformin and flutamide, or
4. Placebo, metformin and placebo

The next six months, all patients will be treated with pioglitazone, metformin and flutamide (open phase), and over the last six months of the trial (double blinded, randomised), half of the patients will receive three placebos and the other half will remain on the same treatment.

Previous interventions:
One group will receive pioglitazone, flutamide and metformin; the other group will receive placebo, flutamide and metformin.

Assessment of endocrine-metabolic variables, neutrophil count, C-Reactive Protein (CRP) levels, body composition, carotid intima media thickness at baseline, and at three and six months.

Intervention type

Drug

Phase

Not Specified

Drug names

Pioglitazone, flutamide, metformin

Primary outcome measures

1. C-reactive protein (CRP) levels
2. Neutrophil count
3. Serum androgens
4. Fasting insulin
5. Lipid profile

Secondary outcome measures

1. Carotid intima-media thickness
2. Body composition (visceral fat)
3. High molecular weight adiponectin (added as of 05/07/2007 as part of the extension)

Overall trial start date

18/11/2005

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 years or more
2. Menarche at least three years before inclusion
3. Clinical and/or biochemical signs of androgen excess
4. Hyperinsulinism
5. Dyslipidemia
6. Relative hyperneutrophilia, increased C-reactive protein (CRP)
7. Normal liver and kidney functions
8. Absence of non-classical adrenal hyperplasia due to 21-OH (21-hydroxylase) deficiency

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

40

Participant exclusion criteria

1. Age less than 18 years
2. Pregnancy
3. Hyperprolactinemia
4. Cushing's syndrome
5. Abnormal thyroid function
6. Liver or kidney dysfunction
7. Glucose intolerance
8. Type 1 or type 2 diabetes
9. Cutaneous allergy
10. Concomitant therapy with agents influencing lipid or carbohydrate metabolism.
11. Alcoholism
12. Bacterial infections

Recruitment start date

18/11/2005

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Sant Joan de Deu
Esplugues
08950
Spain

Sponsor information

Organisation

Hospital Sant Joan de Deu, University of Barcelona (Spain)

Sponsor details

Passeig de Sant Joan de Deu
2
Esplugues
08950
Spain

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Hospital Sant Joan de Deu (Spain)

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

Publication citations

Additional files

Editorial Notes