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

NCT06918873 | Recruiting

• 1 other identifier: REN13
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hormonal Contraception

Keywords

combined hormonal contraception; female sexual dysfunction; mood disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Impact of combined hormonal contraception on mood disorders

  6 months

• Impact of basal clinical variables mood disorders and sexual dysfunction in women using combined hormonal contraception

  6 months

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women referred for prescription of a hormonal contraceptive.

You may qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo, SSD Ostetricia e Ginecologia 2 - Riproduzione e Procreazione Medicalmente Assistita

Pavia, Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Rossella Nappi, MD

CONTACT

+390382503325; r.nappi@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 9, 2025
• Study Start: May 5, 2014
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)