Effects of the addition of low-dose pioglitazone to combined flutamide-metformin treatment on endocrine-metabolic and body composition indices in young women with ovarian hyperandrogenism, hyperinsulinism and cardiovascular risk

ISRCTN ISRCTN12871246
DOI https://doi.org/10.1186/ISRCTN12871246
Secondary identifying numbers HSJD-LIT-05
Submission date
17/11/2005
Registration date
09/01/2006
Last edited
08/04/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Lourdes Ibanez
Scientific

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

Study information

Study designDouble-blind, prospective, randomised, trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleEffects of the addition of low-dose pioglitazone to combined flutamide-metformin treatment on endocrine-metabolic and body composition indices in young women with ovarian hyperandrogenism, hyperinsulinism and cardiovascular risk
Study objectivesHypothesis 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(s)Ethics approval was received on the 5th November 2005; extensions approved on the 27th October 2006.
Health condition(s) or problem(s) studiedOvarian hyperandrogenism with hyperinsulinism, dyslipemia and cardiovascular risk
InterventionPlease 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Pioglitazone, flutamide, metformin
Primary outcome measure1. C-reactive protein (CRP) levels
2. Neutrophil count
3. Serum androgens
4. Fasting insulin
5. Lipid profile
Secondary outcome measures1. 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 study start date18/11/2005
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants40
Total final enrolment38
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment18/11/2005
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • Spain

Study participating centre

Hospital Sant Joan de Deu
Esplugues
08950
Spain

Sponsor information

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

Passeig de Sant Joan de Deu, 2
Esplugues
08950
Spain

ROR logo "ROR" https://ror.org/001jx2139

Funders

Funder type

Hospital/treatment centre

Hospital Sant Joan de Deu (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/09/2009 08/04/2021 Yes No

Editorial Notes

08/04/2021: Publication reference and total final enrolment added.