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Study on the Effect of Combined Oral Contraceptive Therapy on Female Sexuality, Body Image and Mental Health (COSEX)
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.
Details
| Lead sponsor | University of Florence |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 10 |
| Start date | 2015-10 |
| Completion | 2019-02 |
Conditions
- Contraceptive Usage
- Sexual Behavior
- Mental Health Wellness 1
Interventions
- Combined Estrogen-Progestin Oral Contraceptives
Primary outcomes
- Changes in sexual function (FSFI score) — 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. - Changes in sexual distress (FSDS score) — 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. - Changes in clitoris vascularization — 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.
Countries
Italy