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Trial record 9 of 11 for:    "Ovarian Cyst" | "Epinephrine"

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

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ClinicalTrials.gov Identifier: NCT03306459
Recruitment Status : Not yet recruiting
First Posted : October 11, 2017
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Camil Castelo-Branco, Hospital Clinic of Barcelona

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

Condition or disease Intervention/treatment
Polycystic Ovary Syndrome Diagnostic Test: SF-36 (Short Form Health Survey)

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Hospital Clínic Barcelona
Estimated Study Start Date : January 9, 2018
Estimated Primary Completion Date : January 9, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
1/PCOS
The authors will select 30 PCOS patients who met the more strict and conservative Rotterdam diagnostic criteria (Rotterdam phenotype A) which include the presence of oligo-anovulation (cycles lasting >35 days or amenorrhea) and hyperandrogenemia /hyperandrogenism (hirsutism or obvious acne or pronounced alopecia). All patients should have bilateral polycystic ovaries morphology on ultrasound. Additionally, the authors have decided to enroll PCOS patients that are all without pregnancy desire at the moment they fill out the questionnaires, in order to control for the potential confounding role of infertility on psychological outcomes. Different pituitary, adrenal, ovarian, thyroid or metabolic diseases will be excluded
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.

Other Name: Female Sexual Function Index; Symptom Checklist-90-R; State-Trait-Anger-Expression-Inventory

2/CONTROL
The authors will enroll a control group of 30 women, age- matched with the PCOS women, from consecutive women controlled in the same outpatient clinic who met the following inclusion criteria: history of irregular menstrual cycle in absence of severe gynecologic and non-gynecologic diseases. This PCOS sample will be entirely constituted by women with no pregnancy desire; therefore, with the aim to limit the potential effect of the unfulfilled wish to conceive in the final results; additionally, infertile women will not admitted into the control group.
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.

Other Name: Female Sexual Function Index; Symptom Checklist-90-R; State-Trait-Anger-Expression-Inventory




Primary Outcome Measures :
  1. Quality of Life [ Time Frame: january 9th 2018-january 9th 2019 ]
    results of SF-36


Secondary Outcome Measures :
  1. Sexuality [ Time Frame: january 9th 2018-january 9th 2019 ]
    Results of FSFI

  2. Psychological distress [ Time Frame: january 9th 2018-january 9th 2019 ]
    Results of Symptom Checklist-90-Revision (SCL-90-R)

  3. Anger and aggressiveness [ Time Frame: january 9th 2018-january 9th 2019 ]
    results of State-Trait-Anger-Expression-Inventory, version 2 (STAXI-2)


Other Outcome Measures:
  1. Biochemical markers [ Time Frame: january 9th 2018-january 9th 2019 ]
    Results of blood tests including biochemistry and hormones analysis

  2. Phenotipical traits [ Time Frame: january 9th 2018-january 9th 2019 ]
    Record of hirsutism, acne, alopecia, and other hyperandrogenic symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The authors will select 30 PCOS patients who met the more strict and conservative Rotterdam diagnostic criteria (Rotterdam phenotype A)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306459


Contacts
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Contact: Camil Castelo-Branco, MD PhD 1679999037 ccastelo@clinic.cat
Contact: Camil Castelo-Branco

Locations
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Spain
Hospital Clínic Not yet recruiting
Barcelona, Spain, 08036
Contact: Camil Castelo-Branco, MD PhD    +342275436    ccastelo@clinic.cat   
Principal Investigator: Juliia Naumova, MD         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Study Director: Camil Castelo-Branco, MD PhD Hospital Clínic. University of Barcelona

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Responsible Party: Camil Castelo-Branco, Professor, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03306459     History of Changes
Other Study ID Numbers: B/2017/0614
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Camil Castelo-Branco, Hospital Clinic of Barcelona:
PCOS
Quality of life
Sexuality
Psychological traits

Additional relevant MeSH terms:
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Ovarian Cysts
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases