Oral Contraceptive Therapy and Sexuality

• Status: Completed
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florence
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Estrogens; Progestins

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).