Low Sexual Desire and Metabolic Syndrome

NCT02430987 | Completed DMC

• 1 other identifier: 40594814.4.0000.5479
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To evaluate the prevalence of hypoactive sexual desire disorder (HSDD) in postmenopausal women diagnosed with metabolic syndrome (MS) and to compare it to that of a control group without MS. Design: Cross-sectional study. Setting: Two public tertiary hospitals in the state of São Paulo, Brazil. Population: Two-hundred ninety-one postmenopausal women between 40 and 65 years of age. Methods: Sexual function was evaluated using the Female Sexual Function Index (FSFI) questionnaire and DSM-IV-TR diagnostic criteria and was related to the diagnosis of MS, which was determined according to the guidelines defined by the Adult Treatment Panel (ATP III). Main outcome measures: Analysis of sexual function with emphasis on sexual desire (HSDD), the presence of MS and its components.

Conditions

Menopause; Metabolic Syndrome; Hypoactive Sexual Desire Disorder; Obesity; Sexual Dysfunction

Keywords

menopause; hypoative sexual desire disorder; metabolic syndrome; obesity

Outcome Measures

Primary Outcomes (1)

• application of questionnaire

  application of questionnaire about sexuality and sexual function

  1 year

Secondary Outcomes (2)

• Body mass index

  2 years

• Metabolic syndrome

  3 years

Study Arms (2)

Metabolic syndrome

ACTIVE COMPARATOR

The MetS diagnosis was determined by following the guidelines defined by the Adult Treatment Panel (ATP III) (8): (1) Abdominal circumference (AC) ?88cm; (2) HDL-cholesterol \< 50mg/dL; (3) triglycerides \> 150mg/dL; (4) arterial blood pressure (SAH) \> 130/85mmHg; and (5) fasting glucose \> 110mg/dL. The women considered as carrying MetS were those with at least three of the components described. Sexual function was assessed by completion of the Female Sexual Function Index (FSFI), a questionnaire validated for Brazilian Portuguese

Diagnostic Test: Female sexual function index questionnaire; Diagnostic Test: Evaluation of presence of metabolic syndrome

Obesity

PLACEBO COMPARATOR

women were stratified into 3 groups by body mass index (BMI): Group 1: BMI of 18.5 to 24.9kg/m2 (Normal BMI Group), Group 2: BMI of 25 to 29.9kg/m2 (Overweight Group); Group 3: BMI of 30kg/m2 to 34.5kg/m2 or higher) (Obese Group Sexual function was assessed by completion of the Female Sexual Function Index (FSFI), a questionnaire validated for Brazilian Portuguese

Diagnostic Test: Female sexual function index questionnaire; Diagnostic Test: Evaluation of presence of metabolic syndrome; Diagnostic Test: Evaluation of the body mass index

Interventions

Female sexual function index questionnaire DIAGNOSTIC_TEST

Sexual function was assessed by completion of the Female Sexual Function Index (FSFI), a questionnaire validated for Brazilian Portuguese with 19 items measuring female sexual function. Cut-off points of \>23 and \> 26.5 were adopted to define a diagnosis of Female Sexual Function based on the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM -IV- TR) by the American Psychiatric Association, duration criteria \> 24 weeks. A score of 5 or less on the combination of items comprising the desire domain of the FSFI questionnaire was used to define the diagnosis of Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women We consider that a score of 6 or more the woman does not present with HSDD.

Also known as: diagnostic of sexual dysfunction, diagnostic of hypoactive sexual desire disorder

Metabolic syndrome; Obesity

Evaluation of presence of metabolic syndrome DIAGNOSTIC_TEST

The MetS diagnosis was determined by following the guidelines defined by the Adult Treatment Panel (ATP III) (8): (1) Abdominal circumference (AC) ?88cm; (2) HDL-cholesterol \< 50mg/dL; (3) triglycerides \> 150mg/dL; (4) arterial blood pressure (SAH) \> 130/85mmHg; and (5) fasting glucose \> 110mg/dL. The women considered as carrying MetS were those with at least three of the components described.

Metabolic syndrome; Obesity

Evaluation of the body mass index DIAGNOSTIC_TEST

women were stratified into 3 groups by body mass index (BMI): Group 1: BMI of 18.5 to 24.9kg/m2 (Normal BMI Group), Group 2: BMI of 25 to 29.9kg/m2 (Overweight Group); Group 3: BMI of 30kg/m2 to 34.5kg/m2 or higher) (Obese Group

Also known as: Diagnosis of obesity

Obesity

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age;
• One year of amenorrhea and FSH \> 30 mIU/mL14;
• Sexually active - women with regular sexual activity and to have penetrative sex with a partner without a history of sexual dysfunction in the last 4 weeks; and
• Use of oestrogen and progesterone oral or parenteral for over 6 months. This item is to prevent hot flashes and vaginal dryness interference in sexual function.

You may not qualify if:

• Women in the menopause transition period and/or with FSH \<30 mIU/mL;
• Sexually inactive;
• Partner with history of sexual dysfunction, such as erectile dysfunction and/or premature ejaculation;
• Any other form of sexual dysfunction or any other psychiatric disorder that may affect sexual function;
• Diagnosis of depression, with a score of \> 14 on Beck's Depression Inventory;
• Use of oestrogen and progesterone oral or parenteral prescribed less than 6 months ago or prescribed for low sexual desire (tibolone);
• Use of drugs that, according to the examiner's evaluation, may affect sexual function;
• History of bilateral oophorectomy; and
• Diagnosed with cancer (breast, cervix, endometrium, ovary, intestines, among others);

Sponsors & Collaborators

• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Faculdade de Ciências Médicas da Santa Casa de São Paulo: lead

Study Sites (1)

Rua Maria José Pomar, 322 Apartamento 172 C

São Paulo, 02436070, Brazil

Location

Related Publications (3)

• Silva GM, Lima SM, Moraes JC. [Evaluation of sexual function in postmenopause women with metabolic syndrome]. Rev Bras Ginecol Obstet. 2013 Jul;35(7):301-8. doi: 10.1590/s0100-72032013000700004. Portuguese.

  PMID: 24080842 BACKGROUND

• Silva GMDD, Lima SMRR, Reis BFD, Macruz CF, Postigo S. Evaluation of Obesity Influence in the Sexual Function of Postmenopausal Women: A Cross-Sectional Study. Rev Bras Ginecol Obstet. 2019 Nov;41(11):660-667. doi: 10.1055/s-0039-1700795. Epub 2019 Nov 19.

  PMID: 31745959 RESULT

• Dutra da Silva GM, Rolim Rosa Lima SM, Reis BF, Macruz CF, Postigo S. Prevalence of Hypoactive Sexual Desire Disorder Among Sexually Active Postmenopausal Women With Metabolic Syndrome at a Public Hospital Clinic in Brazil: A Cross-sectional Study. Sex Med. 2020 Sep;8(3):545-553. doi: 10.1016/j.esxm.2020.05.008. Epub 2020 Jun 24.

  PMID: 32593675 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Sexual Dysfunctions, Psychological; Obesity; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases; Urogenital Diseases

Study Officials

• Gustavo Maximiliano Dutra da Silva, PhD

  Faculdade de Ciências Médicas da Santa Casa de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: April 30, 2015
• Study Start: September 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

BR (1)