Clinical trial NCT02613039: Oral Contraceptive Therapy and Sexuality
Official title: Study on the Effect of Combined Oral Contraceptive Therapy on Female Sexuality, Body Image and Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraceptive Usage
Sexual Behavior
Mental Health Wellness 1
Keywords: oral contraceptives
female sexuality
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Changes in sexual function (FSFI score)
timeFrame: 6 months and 12 months
measure: Changes in sexual distress (FSDS score)
timeFrame: 6 months and 12 months
measure: Changes in clitoris vascularization
timeFrame: 6 months and 12 months
Secondary outcomes:
measure: Changes in body image perception
timeFrame: 6 months and 12 months
measure: Changes in mood and mental status
timeFrame: 6 months and 12 months
measure: Changes in glycaemia
timeFrame: 6 months and 12 months
measure: Changes in glycated hemoglobin (HbA1c) levels
timeFrame: 6 months and 12 months
measure: Changes in insulin levels
timeFrame: 6 months and 12 months
measure: Changes in total cholesterol levels
timeFrame: 6 months and 12 months
measure: Changes in HDL (high-density lipoprotein) cholesterol levels
timeFrame: 6 months and 12 months
measure: Changes in triglycerides levels
timeFrame: 6 months and 12 months
measure: Changes in total testosterone levels
timeFrame: 6 months and 12 months
measure: Changes in estradiol levels
timeFrame: 6 months and 12 months
measure: Changes in SHBG (sex hormone binding globulin) levels
timeFrame: 6 months and 12 months
measure: Changes in LH (luteinizing hormone) levels
timeFrame: 6 months and 12 months
measure: Changes in FSH (follicle-stimulating hormone) levels
timeFrame: 6 months and 12 months
measure: Changes in prolactin levels
timeFrame: 6 months and 12 months
measure: Changes in delta4-androstenedione levels
timeFrame: 6 months and 12 months
measure: Changes in Dehydroepiandrosterone sulfate (DHEAS) levels
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Ambulatori di Medicina della Sessualità e Andrologia
Study officials:
affiliation: University of Florence
name: Mario Maggi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. doi: 10.1080/00224490409552216.
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.
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 Mar;32(2):239-247. doi: 10.1038/s41443-019-0162-7. Epub 2019 Jul 1.