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Oral Contraceptive Therapy and Sexuality

NCT02613039 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-03-26

No results posted yet for this study

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.

Conditions

  • Contraceptive Usage
  • Sexual Behavior
  • Mental Health Wellness 1

Interventions

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.

Sponsors & Collaborators

  • University of Florence

    lead OTHER

Principal Investigators

  • Mario Maggi · University of Florence

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-02-28
Completion
2019-02-28

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02613039 on ClinicalTrials.gov