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Recruiting NCT06918873

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

Observational Hormonal Contraception

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hormonal Contraception. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Impact of different estrogen-progestin contraception regimens on sexual function and sexually related distress. [Time frame: 6 months]
Secondary outcome measures (2)
  • Impact of combined hormonal contraception on mood disorders [Time frame: 6 months]
  • Impact of basal clinical variables mood disorders and sexual dysfunction in women using combined hormonal contraception [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Fondazione IRCCS Policlinico San Matteo, SSD Ostetricia e Ginecologia 2 - Riproduzione e P — Pavia

Identifiers

NCT: NCT06918873 · REN13

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗