Oral Contraceptive Therapy and Sexuality

Mental Health Wellness 1 Clinical Trial

— COSEX  

Official title:

Study on the Effect of Combined Oral Contraceptive Therapy on Female Sexuality, Body Image and Mental Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613039
• Other study ID #: ANDRO-AOUC-2015-2
• Status: Completed
• Phase: Phase 4
• Start date: October 2015
• Est. completion date: February 2019

Study information

• Verified date: March 2020
• Source: University of Florence
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2019
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Contraceptive Usage
• Mental Health Wellness 1
• Sexual Behavior

Intervention

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.

Locations

Country	Name	City	State
Italy	Ambulatori di Medicina della Sessualità e Andrologia	Florence

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Battaglia C, Battaglia B, Mancini F, Nappi RE, Paradisi R, Venturoli S. Moderate alcohol intake, genital vascularization, and sexuality in young, healthy, eumenorrheic women. A pilot study. J Sex Med. 2011 Aug;8(8):2334-43. doi: 10.1111/j.1743-6109.2011.02310.x. Epub 2011 May 19. — View Citation

Battaglia C, Nappi RE, Mancini F, Cianciosi A, Persico N, Busacchi P, Facchinetti F, de Aloysio D. Menstrual cycle-related morphometric and vascular modifications of the clitoris. J Sex Med. 2008 Dec;5(12):2853-61. doi: 10.1111/j.1743-6109.2008.00972.x. Epub 2008 Aug 28. — View Citation

Bullivant SB, Sellergren SA, Stern K, Spencer NA, Jacob S, Mennella JA, McClintock MK. Women's sexual experience during the menstrual cycle: identification of the sexual phase by noninvasive measurement of luteinizing hormone. J Sex Res. 2004 Feb;41(1):82-93. — View Citation

Scavello I, Maseroli E, Di Stasi V, Cipriani S, Verde N, Magini A, Maggi M, Vignozzi L. Nomegestrol acetate/17beta-estradiol does not negatively alter the vascular resistance of clitoral arteries: a prospective, exploratory study. Int J Impot Res. 2020 Ma — View Citation

Wierman ME, Nappi RE, Avis N, Davis SR, Labrie F, Rosner W, Shifren JL. Endocrine aspects of women's sexual function. J Sex Med. 2010 Jan;7(1 Pt 2):561-85. doi: 10.1111/j.1743-6109.2009.01629.x. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months and 12 months
Primary	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.	6 months and 12 months
Primary	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.	6 months and 12 months
Secondary	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.	6 months and 12 months
Secondary	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.	6 months and 12 months
Secondary	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.	6 months and 12 months
Secondary	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.	6 months and 12 months
Secondary	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.	6 months and 12 months
Secondary	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.	6 months and 12 months
Secondary	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.	6 months and 12 months
Secondary	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.	6 months and 12 months
Secondary	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.	6 months and 12 months
Secondary	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.	6 months and 12 months
Secondary	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.	6 months and 12 months
Secondary	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.	6 months and 12 months
Secondary	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.	6 months and 12 months
Secondary	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.	6 months and 12 months
Secondary	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.	6 months and 12 months
Secondary	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.	6 months and 12 months