Psychological Traits, Sexuality and Quality of Life in Patients With Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

Hospital Clínic Barcelona

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03306459
• Other study ID #: B/2017/0614
• Status: Not yet recruiting
• Phase: N/A
• First received: October 5, 2017
• Last updated: October 19, 2017
• Start date: January 9, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2017
• Source: Hospital Clinic of Barcelona
• Contact: Camil Castelo-Branco, MD PhD
• Phone: 1679999037
• Email: ccastelo[@]clinic.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A prospective assessment of psychological characteristics, quality of life and sexuality in naïve patients.

Description:

This project with PCOS patients include an assessment of quality of life and sexuality in naïve patients.

Hypothesizing that PCOS women would show higher rates of psychological alterations, this study is aimed to investigate the association between polycystic ovary syndrome (PCOS) and psychological disturbances, including anger and to analyze whether the biochemical/phenotypical features of PCOS may play a role in the type and severity of psychological disorders.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: January 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

Inclusion Criteria:

PCOS patients without gestational desire who met the following criteria

• Oligomenorrhea (cycles lasting >35 days) or amenorrhea (no periods in 6 months)

• Hyperandrogenemia/hyperandrogenism Hirsutism Ferriman-Gallwey score > 12 Obvious acne or pronounced alopecia Androgen levels over normal female range

Exclusion Criteria:

• Prior psychiatric diagnosis

• Current use of psychiatric medications

• Difficulties with language comprehension in case of non-nationals.

• Yatrogenic hirsutism,

• Other endocrine deseases with hyperandrogenism or that may influence the final results Ovarian or adrenal neoplasia Prolactinoma Cushing's syndrome Congenital adrenal hyperplasia Diabetes mellitus Thromboembolic disease

• Patients who had received any drug therapy for hirsutism over the last 6 months

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Diagnostic Test:
• SF-36 (Short Form Health Survey)
Symptom Checklist-90-Revision (SCL-90-R): self-report questionnaire of 90 items on a 5-point Likert scale clustered in 9 primary scales (somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism). State-Trait-Anger-Expression-Inventory, version 2 (STAXI-2): self-report questionnaire of 57-items on a 4-point scale distributed in different dimensions: State-Anger, Trait-Anger Expression Anger (in-out) and Anger Control (in-out) Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health. Female Sexual Function Index (FSFI) a 19-item self-report measure of female sexual function providing scores on 6 domains (desire, arousal, lubrication, orgasm, satisfaction, pain) as well as a total score.

Locations

Country	Name	City	State
Spain	Hospital Clínic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biochemical markers	Results of blood tests including biochemistry and hormones analysis	january 9th 2018-january 9th 2019
Other	Phenotipical traits	Record of hirsutism, acne, alopecia, and other hyperandrogenic symptoms	january 9th 2018-january 9th 2019
Primary	Quality of Life	results of SF-36	january 9th 2018-january 9th 2019
Secondary	Sexuality	Results of FSFI	january 9th 2018-january 9th 2019
Secondary	Psychological distress	Results of Symptom Checklist-90-Revision (SCL-90-R)	january 9th 2018-january 9th 2019
Secondary	Anger and aggressiveness	results of State-Trait-Anger-Expression-Inventory, version 2 (STAXI-2)	january 9th 2018-january 9th 2019