Oral Contraceptive Therapy and Sexuality

Phase 4

Completed

• Conditions: Contraceptive Usage; Sexual Behavior; Mental Health Wellness 1
• Interventions: Drug: Combined Estrogen-Progestin Oral Contraceptives

• Registration Number: NCT02613039
• Lead Sponsor: University of Florence

Brief 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.

Detailed 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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-20
• Study First Posted: 2015-11-24
• Primary Completion: 2018-02
• Study Completion: 2019-02
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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.

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
female outpatient subjects	Combined Estrogen-Progestin Oral Contraceptives	Patients requiring combined Oral Contraceptives therapy.

Primary Outcome Measures

Name	Time	Method
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 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 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.

Secondary Outcome Measures

Name	Time	Method
Changes in body image perception	6 months and 12 months	A significant difference in BUT score evaluated at baseline compared with follow-up visits will be considered as a primary endpoint.
Changes in LH (luteinizing hormone) levels	6 months and 12 months	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.
Changes in prolactin levels	6 months and 12 months	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.
Changes in glycaemia	6 months and 12 months	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.
Changes in insulin levels	6 months and 12 months	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.
Changes in estradiol levels	6 months and 12 months	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.
Changes in mood and mental status	6 months and 12 months	A significant difference in MHQ score evaluated at baseline compared with follow-up visits will be considered as a primary endpoint.
Changes in glycated hemoglobin (HbA1c) levels	6 months and 12 months	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.
Changes in total cholesterol levels	6 months and 12 months	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.
Changes in HDL (high-density lipoprotein) cholesterol levels	6 months and 12 months	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.
Changes in total testosterone levels	6 months and 12 months	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.
Changes in triglycerides levels	6 months and 12 months	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.
Changes in SHBG (sex hormone binding globulin) levels	6 months and 12 months	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.
Changes in FSH (follicle-stimulating hormone) levels	6 months and 12 months	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.
Changes in delta4-androstenedione levels	6 months and 12 months	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.
Changes in Dehydroepiandrosterone sulfate (DHEAS) levels	6 months and 12 months	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.

Trial Locations

Locations (1)

Ambulatori di Medicina della Sessualità e Andrologia; 🇮🇹 Florence, Italy