Oral Contraceptive Therapy and Sexuality (COSEX)

U

University of Florence (UNIFI)

Status and phase

Completed
Phase 4

Conditions

Mental Health Wellness 1
Sexual Behavior
Contraceptive Usage

Treatments

Drug: Combined Estrogen-Progestin Oral Contraceptives

Study type

Interventional

Funder types

Other

Identifiers

NCT02613039
ANDRO-AOUC-2015-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

female outpatient subjects
Other group
Description:
Patients requiring combined Oral Contraceptives therapy.
Treatment:
Drug: Combined Estrogen-Progestin Oral Contraceptives

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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