Evaluation of menstrual bleeding pattern and sexual quality of life in women using hormonal or copper intrauterine devices

Bleeding pattern and sexual quality of life in users of hormonal IUD and copper IUD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

REBEC

Registry ID

RBR-4j2cy33

Enrollment

Registered

2026-03-30

Start date

2024-08-26

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Intrauterine Devices

Interventions

The study will employ a prospective, observational, and comparative methodology. The levonorgestrel-releasing intrauterine system (Kyleena®) containing 19.5 mg of intrauterine devices will be inserted

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Women; aged between 18 and 40 years; eligible for the use of an intrauterine device according to the World Health Organization medical eligibility criteria; who chose to use a long-acting reversible contraceptive method, including the levonorgestrel-releasing intrauterine system 19.5 mg or a copper intrauterine device; who agreed to participate in the study by signing the Informed Consent Form

Exclusion criteria

Exclusion criteria: Current pregnancy at the time of inclusion; active genital infection at the time of inclusion or device insertion; medical contraindication to the use of an intrauterine device; refusal to participate in the study or to answer the study questionnaires

Design outcomes

Primary

Measure	Time frame
It is expected to evaluate changes in the bleeding pattern in women using the levonorgestrel-releasing intrauterine system 19.5 mg and the copper intrauterine device, verified through the application of a standardized bleeding pattern questionnaire, based on the comparison of responses obtained at baseline (T0) and twelve months (T12) after device insertion, observing the variation in bleeding pattern between the two evaluation time points.	—

Measure

Time frame

It is expected to evaluate changes in the bleeding pattern in women using the levonorgestrel-releasing intrauterine system 19.5 mg and the copper intrauterine device, verified through the application of a standardized bleeding pattern questionnaire, based on the comparison of responses obtained at baseline (T0) and twelve months (T12) after device insertion, observing the variation in bleeding pattern between the two evaluation time points.

—

Secondary

Measure	Time frame
It is expected to evaluate the variation in sexual quality of life in women using the levonorgestrel-releasing intrauterine system 19.5 mg and the copper intrauterine device, verified through the application of the Female Sexual Function Index (FSFI) questionnaire, based on the comparison of the total FSFI score obtained at baseline (T0) and twelve months (T12) after device insertion, observing the difference in the mean total FSFI scores between the two evaluation time points.	—

Measure

Time frame

It is expected to evaluate the variation in sexual quality of life in women using the levonorgestrel-releasing intrauterine system 19.5 mg and the copper intrauterine device, verified through the application of the Female Sexual Function Index (FSFI) questionnaire, based on the comparison of the total FSFI score obtained at baseline (T0) and twelve months (T12) after device insertion, observing the difference in the mean total FSFI scores between the two evaluation time points.

—

Countries

Contacts

Public ContactZsuzsanna Di Bella

Universidade Federal de São Paulo

zsuvi@uol.com.br+55(11)83490033

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: May 1, 2026