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NCT Number: NCT06918873

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Pavia, 27100, Italy

Location status: Recruiting

Location contact

Rossella Nappi, MD

CONTACT

[email protected]

+390382503325

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Impact of different estrogen-progestin contraception regimens on sexual function and sexually related distress.

    Time frame: 6 months

    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.

Secondary outcomes

  1. Impact of combined hormonal contraception on mood disorders

    Time frame: 6 months

    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).

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

    Time frame: 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rossella Nappi, MD

CONTACT

[email protected]

+390382503325

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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