Quality of Life During Different Regimens of Combined Hormonal Contraceptives in Women of Reproductive Age

The aim of the present study is to investigate the psychosexual effects of combined hormonal contraception regimens, comparing them in terms of estrogen type and dosage, hormonal combination regimen and different routes of administration, in women seeking a hormonal contraception method to prevent unwanted pregnancies. In particular, the study focuses on the incidence of mood disorders and sexual dysfunctions associated with distress in the entire study population using combined hormonal contraception. It will also examine the incidence of these conditions under the influence of specific combined hormonal contraceptives, as well as whether different types of progestins and the route of administration (oral, vaginal or transdermal) may affect the occurrence of mood disorders and sexual dysfunctions.

Study Overview

• Status: Recruiting
• Conditions: Hormonal Contraception

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Rossella Nappi, MD; Phone Number: +390382503325; Email: r.nappi@smatteo.pv.it

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • Fondazione IRCCS Policlinico San Matteo, SSD Ostetricia e Ginecologia 2 - Riproduzione e Procreazione Medicalmente Assistita
    • Contact: Rossella Nappi, MD; Phone Number: +390382503325; Email: r.nappi@smatteo.pv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women referred for prescription of a hormonal contraceptive.

Description

Inclusion Criteria:

• women of childbearing age (aged 18-40) who seek advice for use of combined hormonal contraception (CHC).
• stable relationship

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of different estrogen-progestin contraception regimens on sexual function and sexually related distress.	Evaluate the trend of the scores of the Female Sexual Function Index (FSFI) in the entire study population using combined hormonal contraception (CHC), both at baseline and after 6 months of CHC exposure; evaluate whether the FSFI scores vary significantly in relation to the type and dosage of estrogen used in hormonal contraception; evaluate the extent of female sexual distress score (FSDS) in the entire study population using CHC, both at baseline and after 6 months of CHC exposure; evaluate whether the FSDS scores vary significantly in relation to the type and dosage of estrogen used in hormonal contraception.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of combined hormonal contraception on mood disorders	Evaluate mood disorders (Hospital Anxiety and Depression score [HADS] > 10) in the entire study population taking CHC, at baseline and after 6 months of CHC exposure; evaluate if there are significant differences in the onset mood disorders based on the type of estrogen, its dosage, the pharmacological class of the progestin, and the type of contraceptive administration (oral, vaginal, transdermal).	6 months
Impact of basal clinical variables mood disorders and sexual dysfunction in women using combined hormonal contraception	Evaluate if certain basal characteristics of menstrual cycles, psychological well-being and quality of life (assessed through validated questionnaires) are correlated with the extent of sexual dysfunctions (FSFI, FSDS) and mood (HADS) both at baseline and after 6 months of CHC therapy.	6 months

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2014
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: mood disorders; female sexual dysfunction; combined hormonal contraception
• Other Study ID Numbers: REN13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No