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Trial record 46 of 228 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

Oral Contraceptive Therapy and Sexuality (COSEX)

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ClinicalTrials.gov Identifier: NCT02613039
Recruitment Status : Recruiting
First Posted : November 24, 2015
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Mario Maggi, University of Florence

Brief Summary:

Oral contraceptives (OCs) ameliorate hyperandrogenism and regulate menstrual cycles. To reduce androgenic side effects of first- and second-generation progestins, several new progestins derived from progesterone or spironolactone have been developed in the last few decades. These progestins, such as drospirenone, cyproterone acetate and NOMAC, are designed to bind specifically to the progesterone receptor and to have no androgenic, estrogenic or glucocorticoid actions.

However, OCs with a more pronounced anti-androgenic effects are more likely to induce sexual dysfunction, mainly hypoactive sexual desire disorder, which can highly impact patient and partner's quality of life. Moreover, available data indicate that OC use might increase adiposity in adolescents and might be associated with central redistribution of body fat in young women with Polycystic ovary syndrome (PCOS) without a recognizable difference in clinical anthropometric measurements, including body mass index and waist circumference.

In this context, it would be worth to evaluate the effects of combined OCs on metabolic and sexual health (sexual desire, arousal, and other parameters of sexual health), body image and mood.


Condition or disease Intervention/treatment Phase
Contraceptive Usage Sexual Behavior Mental Health Wellness 1 Drug: Combined Estrogen-Progestin Oral Contraceptives Phase 4

Detailed Description:

Primary study objective Evaluation, in a sample of female outpatient subjects, of the effect of oral contraceptives (OCs) on sexual function and distress, evaluated with the FSFI (Female Sexual Function Index) and FSDS (Female Sexual Distress Scale Revised) questionnaires and through clitoris artery hemodynamic parameters.

Secondary study objectives

Evaluation, in a sample of female outpatient subjects, of the effect of OCs on:

  • body image perception, evaluated with the BUT (Body Uneasiness Test) questionnaire;
  • mood and mental status, evaluated with the MHQ (Middlesex Hospital questionnaire);
  • hormonal and metabolic parameters.

Exploratory Objectives: evaluation of the relationships between hormonal parameters, clinical scores and sexual function, body image, mood in the study population.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on the Effect of Combined Oral Contraceptive Therapy on Female Sexuality, Body Image and Mental Health
Study Start Date : October 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Estrogens

Arm Intervention/treatment
female outpatient subjects
Patients requiring combined Oral Contraceptives therapy.
Drug: Combined Estrogen-Progestin Oral Contraceptives
All patients enrolled will undergo Combined Estrogen-Progestin Oral Contraceptives. Different compounds will be chosen according to the approved indications and clinical practice. Therefore it is not possible to provide a specific trade and/or generic name.




Primary Outcome Measures :
  1. Changes in sexual function (FSFI score) [ Time Frame: 6 months and 12 months ]
    A significant difference in FSFI score evaluated at baseline compared with follow-up visits will be considered as a primary endpoint.

  2. Changes in sexual distress (FSDS score) [ Time Frame: 6 months and 12 months ]
    A significant difference in FSDS score evaluated at baseline compared with follow-up visits will be considered as a primary endpoint.

  3. Changes in clitoris vascularization [ Time Frame: 6 months and 12 months ]
    A significant difference in clitoris artery hemodynamic parameters evaluated at baseline compared with follow-up visits will be considered as a primary endpoint.


Secondary Outcome Measures :
  1. Changes in body image perception [ Time Frame: 6 months and 12 months ]
    A significant difference in BUT score evaluated at baseline compared with follow-up visits will be considered as a primary endpoint.

  2. Changes in mood and mental status [ Time Frame: 6 months and 12 months ]
    A significant difference in MHQ score evaluated at baseline compared with follow-up visits will be considered as a primary endpoint.

  3. Changes in glycaemia [ Time Frame: 6 months and 12 months ]
    A significant difference in glycaemia levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

  4. Changes in glycated hemoglobin (HbA1c) levels [ Time Frame: 6 months and 12 months ]
    A significant difference in HbA1c levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

  5. Changes in insulin levels [ Time Frame: 6 months and 12 months ]
    A significant difference in insulin levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

  6. Changes in total cholesterol levels [ Time Frame: 6 months and 12 months ]
    A significant difference in total cholesterol levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

  7. Changes in HDL (high-density lipoprotein) cholesterol levels [ Time Frame: 6 months and 12 months ]
    A significant difference in HDL cholesterol levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

  8. Changes in triglycerides levels [ Time Frame: 6 months and 12 months ]
    A significant difference in triglycerides levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

  9. Changes in total testosterone levels [ Time Frame: 6 months and 12 months ]
    A significant difference in total testosterone levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

  10. Changes in estradiol levels [ Time Frame: 6 months and 12 months ]
    A significant difference in estradiol levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

  11. Changes in SHBG (sex hormone binding globulin) levels [ Time Frame: 6 months and 12 months ]
    A significant difference in SHBG levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

  12. Changes in LH (luteinizing hormone) levels [ Time Frame: 6 months and 12 months ]
    A significant difference in LH levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

  13. Changes in FSH (follicle-stimulating hormone) levels [ Time Frame: 6 months and 12 months ]
    A significant difference in FSH levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

  14. Changes in prolactin levels [ Time Frame: 6 months and 12 months ]
    A significant difference in prolactin levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

  15. Changes in delta4-androstenedione levels [ Time Frame: 6 months and 12 months ]
    A significant difference in delta4-androstenedione levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.

  16. Changes in Dehydroepiandrosterone sulfate (DHEAS) levels [ Time Frame: 6 months and 12 months ]
    A significant difference in DHEAS levels evaluated at baseline visit and at follow-up visits (6 or 12 months) will be considered as a secondary endpoint.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female subjects aged =/> 18 years and of reproductive age.
  • Capacity to give consent for study participation, after being adequately informed of the aims, benefits, risks, time and motion of the study.

Exclusion Criteria:

  • Participation in another clinical trial.
  • Known or suspected (or history of) malignancy or chronic illness.
  • Serious organic or mental disease diagnosed by a psychiatrist (e.g., major depression currently treated with antidepressant medication) suspected on the basis of the medical history and/or clinical examination.
  • Conditions that may affect the compliance to the study.
  • Contraindications to therapy with the study drug or hypersensitivity to the study drug (active ingredient or excipients of the formulation).

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): NCT02613039


Contacts
Contact: Maro Maggi m.maggi@dfc.unifi.it
Contact: Linda Vignozzi l.vignozzi@dfc.unifi.it

Locations
Italy
Ambulatori di Medicina della Sessualità e Andrologia Recruiting
Florence, Italy
Contact: Mario Maggi       m.maggi@dfc.unifi.it   
Sub-Investigator: Linda Vignozzi         
Sub-Investigator: Elisa Maseroli         
Sub-Investigator: Egidia Fanni         
Sponsors and Collaborators
University of Florence
Investigators
Principal Investigator: Mario Maggi University of Florence

Publications:
Responsible Party: Mario Maggi, Full professor of Endocrinology, University of Florence
ClinicalTrials.gov Identifier: NCT02613039     History of Changes
Other Study ID Numbers: ANDRO-AOUC-2015-2
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by Mario Maggi, University of Florence:
oral contraceptives
female sexuality

Additional relevant MeSH terms:
Contraceptive Agents
Estrogens
Contraceptives, Oral
Contraceptives, Oral, Combined
Progestins
Reproductive Control Agents
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female