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

NCT ID: NCT06918873

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-05

Study Completion Date

2026-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Hormonal Contraception

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Rossella Nappi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Pavia, Pavia, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Rossella Nappi, MD

Role: CONTACT

[email protected]
+390382503325

Facility Contacts

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Rossella Nappi, MD

Role: primary

[email protected]
+390382503325

Other Identifiers

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REN13

Identifier Type: -

Identifier Source: org_study_id

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