Oral Contraceptive Therapy & Sexuality

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02613039
Study type	Interventional
Source	University of Florence
Contact
Status	Completed
Phase	Phase 4
Start date	October 2015
Completion date	February 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Oral Contraceptive Therapy and Sexuality — COSEX

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms