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
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 12
Maximum Age: 23
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Austria
Universitätsklinik für Innere Medizin
RECRUITING
Graz
Denmark
Odense University Hospital (UNIODE)
RECRUITING
Odense
Italy
Azienda Ospedaliero Universitaria di Bologna
RECRUITING
Bologna
Norway
St. Olavs Hospital
RECRUITING
Trondheim
Spain
Hospital Sant Joan de Deu
RECRUITING
Esplugues De Llobregat
Hospital Universitari de Girona Dr. Trueta
RECRUITING
Girona
Turkey
İstanbul Faculty of Medicine Topkapı
RECRUITING
Istanbul
Contact Information
Primary
Rita Malpique, PhD
rita.malpique@sjd.es
+34936 00 97 51
Backup
Elizabeth García Pérez, PhD
+34936 00 97 51
Time Frame
Start Date: 2022-05-24
Estimated Completion Date: 2025-04
Participants
Target number of participants: 364
Treatments
Placebo_comparator: Arm 1 - Placebo
Placebo
Experimental: Arm 1 - PIO
Pioglitazone
Experimental: Arm 1 - SPIO
Spironolactone and Pioglitazone
Experimental: Arm 1 - SPIOMET
Spironolactone, Pioglitazone and Metformin
Sponsors
Leads: Fundació Sant Joan de Déu

This content was sourced from clinicaltrials.gov