A Phase 4 interventional study of Combined Estrogen-Progestin Oral Contraceptives in Contraceptive Usage, Sexual Behavior and Mental Health Wellness 1, sponsored by University of Florence. Completed at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-26.
Sponsored by University of Florence · Phase 4, Interventional, and Treatment
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.
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:
Exploratory Objectives: evaluation of the relationships between hormonal parameters, clinical scores and sexual function, body image, mood in the study population.
University of Florence is the lead sponsor of 75 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients requiring combined Oral Contraceptives therapy.
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.
Changes in sexual function (FSFI score)
A significant difference in FSFI score evaluated at baseline compared with follow-up visits will be considered as a primary endpoint.
Time frame: 6 months and 12 months
Changes in sexual distress (FSDS score)
A significant difference in FSDS score evaluated at baseline compared with follow-up visits will be considered as a primary endpoint.
Time frame: 6 months and 12 months
Changes in clitoris vascularization
A significant difference in clitoris artery hemodynamic parameters evaluated at baseline compared with follow-up visits will be considered as a primary endpoint.
Time frame: 6 months and 12 months
Changes in body image perception
A significant difference in BUT score evaluated at baseline compared with follow-up visits will be considered as a primary endpoint.
Time frame: 6 months and 12 months
Changes in mood and mental status
A significant difference in MHQ score evaluated at baseline compared with follow-up visits will be considered as a primary endpoint.
Time frame: 6 months and 12 months
Changes in glycaemia
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.
Time frame: 6 months and 12 months
Changes in glycated hemoglobin (HbA1c) levels
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.
Time frame: 6 months and 12 months
Changes in insulin levels
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.
Time frame: 6 months and 12 months
Changes in total cholesterol levels
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.
Time frame: 6 months and 12 months
Changes in HDL (high-density lipoprotein) cholesterol levels
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.
Time frame: 6 months and 12 months
Changes in triglycerides levels
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.
Time frame: 6 months and 12 months
Changes in total testosterone levels
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.
Time frame: 6 months and 12 months
Changes in estradiol levels
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.
Time frame: 6 months and 12 months
Changes in SHBG (sex hormone binding globulin) levels
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.
Time frame: 6 months and 12 months
Changes in LH (luteinizing hormone) levels
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.
Time frame: 6 months and 12 months
Changes in FSH (follicle-stimulating hormone) levels
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.
Time frame: 6 months and 12 months
Changes in prolactin levels
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.
Time frame: 6 months and 12 months
Changes in delta4-androstenedione levels
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.
Time frame: 6 months and 12 months
Changes in Dehydroepiandrosterone sulfate (DHEAS) levels
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.
Time frame: 6 months and 12 months
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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