Evaluation of the Effects of Levonorgestrel-releasing Intrauterine Device and Dydrogestreone on Quality of Life and Sexual Life in Patients With Abnormal Uterine Bleeding.

NCT ID: NCT05474703

Last Updated: 2022-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 171 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-20
• Study Completion Date: 2022-08-10

Brief Summary

This study was retrospectively collected from patients who were diagnosed with abnormal uterine bleeding and received oral dydrogesterone therapy for at least six months or who were administered an intrauterine device containing levonorgestrel at least six months ago, and prospectively Short form 36 (P-36); It covers the comparison of the Quality of Life Scale and the Female Sexual Function Scale (FSFI) by asking over the phone.

Detailed Description

This study aimed to apply to the Gynecology and Obstetrics Clinic of Istanbul Health Sciences University Kanuni Sultan Süleyman Training and Research Hospital between August 2020 and December 2021, diagnosed with abnormal uterine bleeding between the ages of 18-45 and receive oral dydrogesterone treatment for at least six months or an intrauterine device releasing levonorgestrel. A total of 171 sexually active female patients who were treated were included. Of the patients participating in the study, 86 comprised two groups of patients who received LNG-IUD, and 85 received oral dydrogesterone treatment.

This study was retrospectively collected from patients who were diagnosed with abnormal uterine bleeding and received oral dydrogesterone therapy for at least six months or who had an intrauterine device containing levonorgestrel at least six months ago, and prospectively Short form 36 (P-36); It covers the comparison of the Quality of Life Scale and the Female Sexual Function Scale (FSFI) by asking over the phone.

Patients outside the age range of 18-45, sexually inactive patients, patients in pregnancy or postpartum, patients with known malignancy history or suspected malignancy, patients with abnormal smear results, patients with bleeding diathesis, patients using drugs that may cause vaginal bleeding, gynecological patients. Patients with any organic pathology that could explain bleeding on examination, patients with levonorgestrel-releasing intrauterine mediator dislocated, and patients who had previously received different treatments for abnormal uterine bleeding were not included.

Conditions

Abnormal Uterine Bleeding

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

AUK with Dydrogestrone

Patients who applied for abnormal uterine bleeding and received oral dydrogesterone therapy for at least 6 months

SF-36 Scores

Intervention Type: OTHER

From the electronic database system of our hospital, patients who applied to the gynecology polyclinics of our hospital due to abnormal uterine bleeding between August 2020 and December 2021 and were administered oral dydrogesterone therapy or an intrauterine device releasing levonorgestrel for at least six months were reached using the phone numbers registered in the system.

The patients were informed about the study conducted by teleconference method, and the patients whose verbal consent was obtained were included in the study. After questioning the patients' sociodemographic characteristics such as age, marital status, educational status, income level, employment status, and obstetric history, the patients received the Short form 36 (P-36), consisting of 36 items; The Quality of Life Scale and the Female Sexual Function Scale (FSFI) composed of 19 items were applied.

AUK with Levonorgestrel releasing intrauterin device

Patients who applied for abnormal uterine bleeding and were administered levonorgestrel-releasing intrauterine device at least 6 months ago

SF-36 Scores

Intervention Type: OTHER

From the electronic database system of our hospital, patients who applied to the gynecology polyclinics of our hospital due to abnormal uterine bleeding between August 2020 and December 2021 and were administered oral dydrogesterone therapy or an intrauterine device releasing levonorgestrel for at least six months were reached using the phone numbers registered in the system.

The patients were informed about the study conducted by teleconference method, and the patients whose verbal consent was obtained were included in the study. After questioning the patients' sociodemographic characteristics such as age, marital status, educational status, income level, employment status, and obstetric history, the patients received the Short form 36 (P-36), consisting of 36 items; The Quality of Life Scale and the Female Sexual Function Scale (FSFI) composed of 19 items were applied.

Interventions

SF-36 Scores

From the electronic database system of our hospital, patients who applied to the gynecology polyclinics of our hospital due to abnormal uterine bleeding between August 2020 and December 2021 and were administered oral dydrogesterone therapy or an intrauterine device releasing levonorgestrel for at least six months were reached using the phone numbers registered in the system.

The patients were informed about the study conducted by teleconference method, and the patients whose verbal consent was obtained were included in the study. After questioning the patients' sociodemographic characteristics such as age, marital status, educational status, income level, employment status, and obstetric history, the patients received the Short form 36 (P-36), consisting of 36 items; The Quality of Life Scale and the Female Sexual Function Scale (FSFI) composed of 19 items were applied.

Intervention Type: OTHER

Other Intervention Names

FSFI scores

Eligibility Criteria

Inclusion Criteria

• Sexually active patients with abnormal uterine bleeding
• Patients with no known malignancy history or suspected malignancy, patients with average smear results,
• Patients without bleeding diathesis,
• Patients using drugs that may cause vaginal bleeding,

Exclusion Criteria

• Sexually inactive patients
• Patients in pregnancy or postpartum period,
• Patients with a known history of malignancy or suspected malignancy, patients with abnormal smear results,
• Patients with bleeding diathesis,
• Patients using drugs that may cause vaginal bleeding, patients with any organic pathology to explain the bleeding in gynecological examination
• Patients with a dislocated levonorgestrel-releasing intrauterine device
• Patients who have previously received different treatments for abnormal uterine bleeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pınar Yalcin bahat

Principial investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pinar Yalcin Bahat

Istanbul, İ̇stanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Duphastonversusmirena

Identifier Type: -

Identifier Source: org_study_id