Ignite Creation Date:
2024-05-06 @ 5:41 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05394142
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2022-05-09
Brief Title:
A Clinical Trial to Evaluate the Efficacy Tolerability and Safety of a Fixed Dose Combination of Spironolactone Pioglitazone Metformin SPIOMET in Polycystic Ovary Syndrome PCOS
Sponsor:
Fundació Sant Joan de Déu
Organization:
Fundació Sant Joan de Déu
Study Overview
Official Title:
A Phase II Randomised Multi-centric Multi-national Clinical Trial to Evaluate the Efficacy Tolerability and Safety of a Fixed Dose Combination of Spironolactone Pioglitazone Metformin SPIOMET for Adolescent Girls and Young Adult Women AYAs With Polycystic Ovary Syndrome PCOS
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPIOMET4HEALTH
Brief Summary:
This is a multi-centre multi-national double-blinded placebo-controlled parallel randomised Phase II clinical trial to evaluate the efficacy tolerability and safety of a fixed dose combination of Spironolactone Pioglitazone and Metformin SPIOMET for adolescent girls and young adult women with polycystic ovary syndrome
Study description Currently there is no European Medicines Agency US Food and Drug Administration FDA-approved therapy for polycystic ovary syndrome in adolescent girls and young adult women Oral contraceptives OCs are prescribed off-label to approximately 98 of AYAs with PCOS including those without pregnancy risk OCs alleviate key symptoms by inducing a pharmacological combination of anovulatory subfertility regular pseudo-menses and extreme elevations of sex hormone-binding globulin SHBG but OCs do not revert the underlying pathophysiology and patients remain at risk for post-treatment subfertility and possibly for lifelong co-morbidities
Given the key role of hepato-visceral fat excess in the pathogenesis of PCOS the prime aim of the treatment should be to achieve a preferential loss of central fat which should in turn normalise the entire PCOS phenotype Recent evidence disclosed that a treatment consisting of a fixed low-dose combination of two insulin sensitisers pioglitazone PIO and metformin MET with different modes of action and one mixed anti-androgen and anti-mineralocorticoid spironolactone was superior to an OC in normalising the PCOS phenotype including ovulation rates and hepato-visceral fat
The studys main goals are to assess the efficacy tolerability and safety of a new treatment SPIOMET for adolescent girls and young adult women with polycistic ovarian syndrome the comparison in this order of each SPIOMET spironolactone and pioglitazone SPIO and PIO over placebo and in addition the comparison of SPIOMET over PIO and over SPIO in this order
Primary Objective To test the efficacy of SPIOMET in normalising ovulation rate in adolescents and young adult women with PCOS
Secondary Objectives To test the efficacy of SPIOMET in normalising the endocrine-metabolic status to describe the drug safety profile and to assess the adherence and subjective acceptability as well as the quality of life of the participating subjects
Study description Currently there is no European Medicines Agency US Food and Drug Administration FDA-approved therapy for polycystic ovary syndrome in adolescent girls and young adult women Oral contraceptives OCs are prescribed off-label to approximately 98 of AYAs with PCOS including those without pregnancy risk OCs alleviate key symptoms by inducing a pharmacological combination of anovulatory subfertility regular pseudo-menses and extreme elevations of sex hormone-binding globulin SHBG but OCs do not revert the underlying pathophysiology and patients remain at risk for post-treatment subfertility and possibly for lifelong co-morbidities
Given the key role of hepato-visceral fat excess in the pathogenesis of PCOS the prime aim of the treatment should be to achieve a preferential loss of central fat which should in turn normalise the entire PCOS phenotype Recent evidence disclosed that a treatment consisting of a fixed low-dose combination of two insulin sensitisers pioglitazone PIO and metformin MET with different modes of action and one mixed anti-androgen and anti-mineralocorticoid spironolactone was superior to an OC in normalising the PCOS phenotype including ovulation rates and hepato-visceral fat
The studys main goals are to assess the efficacy tolerability and safety of a new treatment SPIOMET for adolescent girls and young adult women with polycistic ovarian syndrome the comparison in this order of each SPIOMET spironolactone and pioglitazone SPIO and PIO over placebo and in addition the comparison of SPIOMET over PIO and over SPIO in this order
Primary Objective To test the efficacy of SPIOMET in normalising ovulation rate in adolescents and young adult women with PCOS
Secondary Objectives To test the efficacy of SPIOMET in normalising the endocrine-metabolic status to describe the drug safety profile and to assess the adherence and subjective acceptability as well as the quality of life of the participating subjects
Detailed Description:
This is a multi-centre multi-national double-blinded placebo-controlled parallel randomised Phase II clinical trial to evaluate the efficacy tolerability and safety of a fixed dose combination of Spironolactone Pioglitazone and Metformin SPIOMET for adolescent girls and young adult women AYAs with polycystic ovary syndrome PCOS
Study description Currently there is no European Medicines Agency EMAUS Food and Drug Administration FDA-approved therapy for PCOS in AYAs Oral contraceptives OCs are prescribed off-label to approximately 98 of AYAs with PCOS including those without pregnancy risk OCs alleviate key symptoms by inducing a pharmacological combination of anovulatory subfertility regular pseudo-menses and extreme elevations of sex hormone-binding globulin SHBG but OCs do not revert the underlying pathophysiology and patients remain at risk for post-treatment subfertility and possibly for lifelong co-morbidities
Given the key role of hepato-visceral fat excess in the pathogenesis of PCOS the prime aim of the treatment should be to achieve a preferential loss of central fat which should in turn normalise the entire PCOS phenotype Recent evidence disclosed that a treatment consisting of a fixed low-dose combination of two insulin sensitisers pioglitazone PIO and metformin MET with different modes of action and one mixed anti-androgen and anti-mineralocorticoid spironolactone was superior to an OC in normalising the PCOS phenotype including ovulation rates and hepato-visceral fat
Study description Currently there is no European Medicines Agency EMAUS Food and Drug Administration FDA-approved therapy for PCOS in AYAs Oral contraceptives OCs are prescribed off-label to approximately 98 of AYAs with PCOS including those without pregnancy risk OCs alleviate key symptoms by inducing a pharmacological combination of anovulatory subfertility regular pseudo-menses and extreme elevations of sex hormone-binding globulin SHBG but OCs do not revert the underlying pathophysiology and patients remain at risk for post-treatment subfertility and possibly for lifelong co-morbidities
Given the key role of hepato-visceral fat excess in the pathogenesis of PCOS the prime aim of the treatment should be to achieve a preferential loss of central fat which should in turn normalise the entire PCOS phenotype Recent evidence disclosed that a treatment consisting of a fixed low-dose combination of two insulin sensitisers pioglitazone PIO and metformin MET with different modes of action and one mixed anti-androgen and anti-mineralocorticoid spironolactone was superior to an OC in normalising the PCOS phenotype including ovulation rates and hepato-visceral fat
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-003177-58 | EUDRACT_NUMBER | None | None |