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
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