Quality of Life During Different Regimens of Combined Hormonal Contraceptives in Women of Reproductive Age
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Impact of different estrogen-progestin contraception regimens on sexual function and sexually related distress.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •women of childbearing age (aged 18-40) who seek advice for use of combined hormonal contraception (CHC).
- •stable relationship
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
- Impact of combined hormonal contraception on mood disorders(6 months)
- Impact of basal clinical variables mood disorders and sexual dysfunction in women using combined hormonal contraception(6 months)
Investigators
Rossella Nappi
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia