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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) (SPIOMET4HEALTH)

Primary Purpose

Polycystic Ovary Syndrome (PCOS)

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Pioglitazone
Spironolactone
Metformin
Sponsored by
Fundació Sant Joan de Déu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome (PCOS) focused on measuring polycystic ovary syndrome, spironolactone, pioglitazone, metformin, peadiatric, PCOS

Eligibility Criteria

12 Years - 23 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age range within the AYAs category (> 12.0 years and ≤ 23.9 years at study start) (96); Given that another inclusion criterium is gynaecological age (years elapsed since menarche) of 2 years or more, and that menarche before age 10.0 years is an exclusion criterium (please see exclusion criteria below), the youngest participant will be older than 12.0 years at study start (97). The upper age limit at study start is set at 23.9 years (thus, 24.9 years when the active treatment ends, see section 7. Conduct), in order to avoid early dropouts due to an increase in the prevalence of pregnancy wish beyond that age in most European countries;
  2. Gynaecological age of 2 years or more;
  3. Clinical androgen excess, as defined by the presence of hirsutism (modified Ferriman-Gallwey score ≥ 4) (17,98) and/or inflammatory acne (Leeds scale) unresponsive to medications (3,95,99). The scarce normative data existing in adolescents suggest that an adult level of hirsutism is reached around 2 years after menarche (100);
  4. Biochemical androgen excess, as defined by increased total testosterone (≥50 ng/dL), and/or a FAI higher than 3.5 [FAI, total testosterone (nmol/L) x 100/SHBG (nmol/L)], in the follicular phase of the cycle (days 3-7) or after 2 months of amenorrhea (3,100,101); Measurements of total testosterone and/or FAI are the most recommended assessments to screen for hyperandrogenaemia (3,19,95,102). Serum testosterone attains adult levels shortly after menarche; thus, an elevation of serum testosterone concentrations and/or FAI above adult norms and assessed in reliable reference laboratories constitutes biochemical evidence of hyperandrogenism (3,19,95,100). It is accepted that this upper limit can be set at 45 ng/dL for testosterone and at 3.5 for FAI (3,95,100,101,102,103). Direct free testosterone assays, such as radiometric or enzyme-linked assays, preferably should not be used in the assessment of biochemical hyperandrogenism, as they demonstrate poor sensitivity, accuracy and precision (17);
  5. Menstrual irregularity, as defined by ≤ 8 menses per year corresponding to an average inter-menstrual time of ≥45 days (3,95,100); Most adolescents establish a menstrual interval of 20-45 days within the first 2 years after menarche (3,95). Three years after menarche, the 95th percentile for cycle length is 43.6 days (104); thus, cycles longer than 45 days (<8 periods/year) at or beyond this gynaecological age are considered abnormal and are evidence of oligo-anovulation;
  6. Written informed consent obtained from the patient, or assent from the patient and consent by the parents or the legally acceptable representative if she is a minor (for details, see section 7. Conduct, under informed consent).

Exclusion Criteria:

-

Sites / Locations

  • Universitätsklinik für Innere Medizin
  • Odense University Hospital (UNIODE)Recruiting
  • Azienda Ospedaliero Universitaria di Bologna
  • St. Olavs Hospital
  • Hospital Sant Joan de DeuRecruiting
  • Hospital Universitari de Girona Dr. TruetaRecruiting
  • İstanbul Faculty of Medicine Topkapı

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Arm 1 - Placebo

Arm 1 - PIO

Arm 1 - SPIO

Arm 1 - SPIOMET

Arm Description

Placebo

Pioglitazone

Spironolactone and Pioglitazone

Spironolactone, Pioglitazone and Metformin

Outcomes

Primary Outcome Measures

On-treatment ovulation rate.
On-treatment ovulation rate.
Post-treatment ovulation rate.
Post-treatment ovulation rate.

Secondary Outcome Measures

Clinical variable: hirsutism
Presence of hirsutism as measured by the modified Ferriman & Gallwey score
Clinical variable: Acne
Presence of Acne as evaluated using the Leeds Acne Grading Scale
Clinical variable: menstrual regularity
Assessment of the menstrual regularity
Circulating androgens
Assessment by measurement of circulating androgens
Lipids
Assessment by measurement of total cholesterol, low-density lipoprotein (LDL-cholesterol), high-density lipoprotein (HDL- cholesterol), triglycerides;
Insulinaemia
Fasting and 2 hours after a 75-gr oral glucose load [oral glucose tolerance test (oGTT). Estimation of insulin resistance from fasting insulin and glucose levels using the homeostasis model assessment (HOMA);
Inflammation markers
Inflammation markers
Insulin sensitivity
Insulin sensitivity
Ultra-sensitive C-reactive protein (us-CRP);
Ultra-sensitive C-reactive protein (us-CRP);
Growth-and- differentiation factor-15 (GDF15);
Growth-and- differentiation factor-15 (GDF15);
High molecular weight adiponectin (HMW-adip),
High molecular weight adiponectin (HMW-adip),
C-X-C motif chemokine ligand 14 (CXCL14) (69,81);
C-X-C motif chemokine ligand 14 (CXCL14) (69,81);
Epigenetic variable
Circulating microRNA 451-a (miR-451a) concentrations (88);
Imaging: Cardiovascular risk
As measured by ultrasound
Imaging: Body composition
As measured by dual-energy X-ray absorptiometry (DXA)
Imaging: Abdominal fat distribution (subcutaneous and visceral)
As measured by MRI
Imaging:hepatic fat
As measured by MRI
Abdominal fat distribution
Waist circumference, Waist to hip ratio (WHR), and hepatic fat by MRI
Weight
Weight measurement
Improvement of co-morbidities
Improvement of co-morbidities
Improvement of health behaviour
Improvement of health behaviour
Improvement of health-related quality of life (HRQoL)
As reported by the patient
Safety laboratory tests
Blood count, electrolyte panel, urea, alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyltransferase (GGT), creatinine, vitamin B12 and folic acid;
Adverse events (AEs)
As reported by the patient
Adherence
Adherence will be calculated as the ratio between the number of tablets prescribed and dispensed for the period between hospital appointments and the number of tablets returned by the patient at the following appointment;
Acceptability of the treatment
Acceptability of the tablet by the study patients
PROMs (patient-reported outcomes)
Questionnaire SF-36
PROMs (patient-reported outcomes)
Questionnaire PCOSQ
HRQoL (health-related quality of life)
Questionnaire SF-36
HRQoL (health-related quality of life)
Questionnaire PCOSQ

Full Information

First Posted
May 9, 2022
Last Updated
July 6, 2022
Sponsor
Fundació Sant Joan de Déu
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1. Study Identification

Unique Protocol Identification Number
NCT05394142
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)
Acronym
SPIOMET4HEALTH
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2022 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Sant Joan de Déu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 /U.S. 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 study's 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 (EMA)/U.S. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome (PCOS)
Keywords
polycystic ovary syndrome, spironolactone, pioglitazone, metformin, peadiatric, PCOS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This is a multi-centre, multi-national, double-blinded, placebo-controlled, parallel, randomised Phase 2 clinical trial with four subgroups
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
364 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 - Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Arm 1 - PIO
Arm Type
Experimental
Arm Description
Pioglitazone
Arm Title
Arm 1 - SPIO
Arm Type
Experimental
Arm Description
Spironolactone and Pioglitazone
Arm Title
Arm 1 - SPIOMET
Arm Type
Experimental
Arm Description
Spironolactone, Pioglitazone and Metformin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Comparator arm with placebo
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Other Intervention Name(s)
PIO
Intervention Description
Pioglitazone 7.5 mg/day
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Other Intervention Name(s)
S
Intervention Description
Spironolactone 50 mg/day
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
MET
Intervention Description
Metformin 850 mg/day
Primary Outcome Measure Information:
Title
On-treatment ovulation rate.
Description
On-treatment ovulation rate.
Time Frame
Following end of each two 12-week on-treatment periods (month 0-3 and month 9-12)
Title
Post-treatment ovulation rate.
Description
Post-treatment ovulation rate.
Time Frame
Following the end of post-treatment period (month 12-15)
Secondary Outcome Measure Information:
Title
Clinical variable: hirsutism
Description
Presence of hirsutism as measured by the modified Ferriman & Gallwey score
Time Frame
Every 3 months from study start to study completion (estimated 18 months)
Title
Clinical variable: Acne
Description
Presence of Acne as evaluated using the Leeds Acne Grading Scale
Time Frame
Every 3 months from study start to study completion (estimated 18 months)
Title
Clinical variable: menstrual regularity
Description
Assessment of the menstrual regularity
Time Frame
Every 3 months from study start to study completion (estimated 18 months)
Title
Circulating androgens
Description
Assessment by measurement of circulating androgens
Time Frame
Every 3 months from study start to study completion (estimated 18 months)
Title
Lipids
Description
Assessment by measurement of total cholesterol, low-density lipoprotein (LDL-cholesterol), high-density lipoprotein (HDL- cholesterol), triglycerides;
Time Frame
Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment
Title
Insulinaemia
Description
Fasting and 2 hours after a 75-gr oral glucose load [oral glucose tolerance test (oGTT). Estimation of insulin resistance from fasting insulin and glucose levels using the homeostasis model assessment (HOMA);
Time Frame
Baseline and at the end of treatment (month 12) and 6 months after treatment
Title
Inflammation markers
Description
Inflammation markers
Time Frame
Baseline and at the end of treatment (month 12) and 6 months after treatment
Title
Insulin sensitivity
Description
Insulin sensitivity
Time Frame
Baseline and at the end of treatment (month 12) and 6 months after treatment
Title
Ultra-sensitive C-reactive protein (us-CRP);
Description
Ultra-sensitive C-reactive protein (us-CRP);
Time Frame
Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment
Title
Growth-and- differentiation factor-15 (GDF15);
Description
Growth-and- differentiation factor-15 (GDF15);
Time Frame
Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment
Title
High molecular weight adiponectin (HMW-adip),
Description
High molecular weight adiponectin (HMW-adip),
Time Frame
Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment
Title
C-X-C motif chemokine ligand 14 (CXCL14) (69,81);
Description
C-X-C motif chemokine ligand 14 (CXCL14) (69,81);
Time Frame
Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment
Title
Epigenetic variable
Description
Circulating microRNA 451-a (miR-451a) concentrations (88);
Time Frame
Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment
Title
Imaging: Cardiovascular risk
Description
As measured by ultrasound
Time Frame
Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment
Title
Imaging: Body composition
Description
As measured by dual-energy X-ray absorptiometry (DXA)
Time Frame
Baseline and at the end of treatment (month 12) and 6 months after treatment
Title
Imaging: Abdominal fat distribution (subcutaneous and visceral)
Description
As measured by MRI
Time Frame
Baseline and at the end of treatment (month 12) and 6 months after treatment
Title
Imaging:hepatic fat
Description
As measured by MRI
Time Frame
Baseline and at the end of treatment (month 12) and 6 months after treatment
Title
Abdominal fat distribution
Description
Waist circumference, Waist to hip ratio (WHR), and hepatic fat by MRI
Time Frame
Baseline and at the end of treatment (month 12) and 6 months after treatment
Title
Weight
Description
Weight measurement
Time Frame
Every 3 months from study start to study completion (estimated 18 months)
Title
Improvement of co-morbidities
Description
Improvement of co-morbidities
Time Frame
Every 3 months from study start to study completion (estimated 18 months)
Title
Improvement of health behaviour
Description
Improvement of health behaviour
Time Frame
Every 3 months from study start to study completion (estimated 18 months)
Title
Improvement of health-related quality of life (HRQoL)
Description
As reported by the patient
Time Frame
Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment
Title
Safety laboratory tests
Description
Blood count, electrolyte panel, urea, alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyltransferase (GGT), creatinine, vitamin B12 and folic acid;
Time Frame
Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment
Title
Adverse events (AEs)
Description
As reported by the patient
Time Frame
Every 3 months from study start to study completion (estimated 18 months)
Title
Adherence
Description
Adherence will be calculated as the ratio between the number of tablets prescribed and dispensed for the period between hospital appointments and the number of tablets returned by the patient at the following appointment;
Time Frame
Every 3 months from study start to study completion (estimated 18 months)
Title
Acceptability of the treatment
Description
Acceptability of the tablet by the study patients
Time Frame
Every 3 months from study start to study completion (estimated 18 months)
Title
PROMs (patient-reported outcomes)
Description
Questionnaire SF-36
Time Frame
Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment
Title
PROMs (patient-reported outcomes)
Description
Questionnaire PCOSQ
Time Frame
Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment
Title
HRQoL (health-related quality of life)
Description
Questionnaire SF-36
Time Frame
Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment
Title
HRQoL (health-related quality of life)
Description
Questionnaire PCOSQ
Time Frame
Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age range within the AYAs category (> 12.0 years and ≤ 23.9 years at study start) (96); Given that another inclusion criterium is gynaecological age (years elapsed since menarche) of 2 years or more, and that menarche before age 10.0 years is an exclusion criterium (please see exclusion criteria below), the youngest participant will be older than 12.0 years at study start (97). The upper age limit at study start is set at 23.9 years (thus, 24.9 years when the active treatment ends, see section 7. Conduct), in order to avoid early dropouts due to an increase in the prevalence of pregnancy wish beyond that age in most European countries; Gynaecological age of 2 years or more; Clinical androgen excess, as defined by the presence of hirsutism (modified Ferriman-Gallwey score ≥ 4) (17,98) and/or inflammatory acne (Leeds scale) unresponsive to medications (3,95,99). The scarce normative data existing in adolescents suggest that an adult level of hirsutism is reached around 2 years after menarche (100); Biochemical androgen excess, as defined by increased total testosterone (≥50 ng/dL), and/or a FAI higher than 3.5 [FAI, total testosterone (nmol/L) x 100/SHBG (nmol/L)], in the follicular phase of the cycle (days 3-7) or after 2 months of amenorrhea (3,100,101); Measurements of total testosterone and/or FAI are the most recommended assessments to screen for hyperandrogenaemia (3,19,95,102). Serum testosterone attains adult levels shortly after menarche; thus, an elevation of serum testosterone concentrations and/or FAI above adult norms and assessed in reliable reference laboratories constitutes biochemical evidence of hyperandrogenism (3,19,95,100). It is accepted that this upper limit can be set at 45 ng/dL for testosterone and at 3.5 for FAI (3,95,100,101,102,103). Direct free testosterone assays, such as radiometric or enzyme-linked assays, preferably should not be used in the assessment of biochemical hyperandrogenism, as they demonstrate poor sensitivity, accuracy and precision (17); Menstrual irregularity, as defined by ≤ 8 menses per year corresponding to an average inter-menstrual time of ≥45 days (3,95,100); Most adolescents establish a menstrual interval of 20-45 days within the first 2 years after menarche (3,95). Three years after menarche, the 95th percentile for cycle length is 43.6 days (104); thus, cycles longer than 45 days (<8 periods/year) at or beyond this gynaecological age are considered abnormal and are evidence of oligo-anovulation; Written informed consent obtained from the patient, or assent from the patient and consent by the parents or the legally acceptable representative if she is a minor (for details, see section 7. Conduct, under informed consent). Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rita Malpique, PhD
Phone
+34936 00 97 51
Ext
77806
Email
rita.malpique@sjd.es
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth García Pérez, PhD
Phone
+34936 00 97 51
Ext
77848
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lourdes Ibañez, MD, PhD
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinik für Innere Medizin
City
Graz
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Obermayer-Pietsch
Facility Name
Odense University Hospital (UNIODE)
City
Odense
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pernille Ravn
Facility Name
Azienda Ospedaliero Universitaria di Bologna
City
Bologna
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Gambineri
Facility Name
St. Olavs Hospital
City
Trondheim
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eszter Vanky
Facility Name
Hospital Sant Joan de Deu
City
Esplugues De Llobregat
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lourdes Ibañez
Facility Name
Hospital Universitari de Girona Dr. Trueta
City
Girona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abel López Bermejo
Facility Name
İstanbul Faculty of Medicine Topkapı
City
Istanbul
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feyza Darendeliler

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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)

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