Study on the Effect of Combined Oral Contraceptive Therapy on Female Sexuality, Body Image and Mental Health
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes in sexual distress (FSDS score)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
female outpatient subjects
Patients requiring combined Oral Contraceptives therapy.
干预措施: Combined Estrogen-Progestin Oral Contraceptives (Drug)
结局指标
主要结局
Changes in sexual distress (FSDS score)
时间窗: 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 sexual function (FSFI score)
时间窗: 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 clitoris vascularization
时间窗: 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.
次要结局
- Changes in body image perception(6 months and 12 months)
- Changes in glycaemia(6 months and 12 months)
- Changes in insulin levels(6 months and 12 months)
- Changes in mood and mental status(6 months and 12 months)
- Changes in glycated hemoglobin (HbA1c) levels(6 months and 12 months)
- Changes in total cholesterol levels(6 months and 12 months)
- Changes in HDL (high-density lipoprotein) cholesterol levels(6 months and 12 months)
- Changes in total testosterone levels(6 months and 12 months)
- Changes in estradiol levels(6 months and 12 months)
- Changes in triglycerides levels(6 months and 12 months)
- Changes in SHBG (sex hormone binding globulin) levels(6 months and 12 months)
- Changes in LH (luteinizing hormone) levels(6 months and 12 months)
- Changes in prolactin levels(6 months and 12 months)
- Changes in FSH (follicle-stimulating hormone) levels(6 months and 12 months)
- Changes in delta4-androstenedione levels(6 months and 12 months)
- Changes in Dehydroepiandrosterone sulfate (DHEAS) levels(6 months and 12 months)
研究者
Mario Maggi
Full professor of Endocrinology
University of Florence