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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorFondazione IRCCS Policlinico San Matteo di Pavia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

stable relationship

Disqualifiers

None

Trial population

Women referred for prescription of a hormonal contraceptive.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

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).

Time frame
6 months
2

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.

Time frame
6 months

Other outcomes

Sponsors and contacts

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