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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06918873

Enrollment

400

Registered

2025-04-09

Start date

2014-05-05

Completion date

2026-01-31

Last updated

2025-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hormonal Contraception

Keywords

combined hormonal contraception, female sexual dysfunction, mood disorders

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Impact of different estrogen-progestin contraception regimens on sexual function and sexually related distress.	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

Measure	Time frame	Description
Impact of combined hormonal contraception on mood disorders	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).
Impact of basal clinical variables mood disorders and sexual dysfunction in women using combined hormonal contraception	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.

Countries

Italy

Contacts

Primary ContactRossella Nappi, MD

r.nappi@smatteo.pv.it+390382503325

Outcome results