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Completed

NCT Number: NCT02613039

Oral Contraceptive Therapy and Sexuality

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.

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Key information

Conditions

Contraceptive Usage Behavior Contraception Behavior Mental Health Wellness 1 Reproductive Behavior Sexual Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ambulatori di Medicina della Sessualità e Andrologia

Florence, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Combined Estrogen-Progestin Oral Contraceptives

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Registry information

Official study title

Study on the Effect of Combined Oral Contraceptive Therapy on Female Sexuality, Body Image and Mental Health

Acronym: COSEX

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Nov 24, 2015
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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