NCT02613039

Oral Contraceptive Therapy and Sexuality

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Florence · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Contraceptive Usage
• Sexual Behavior
• Mental Health Wellness 1

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-02-01
• Completion: 2019-02-01
• First posted: 2015-11-24
• Last updated: 2020-03-26

Locations

1 site across 1 country: Italy