Evaluation of the Effects of Levonorgestrel-releasing Intrauterine Device

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05474703
Study type	Observational [Patient Registry]
Source	Kanuni Sultan Suleyman Training and Research Hospital
Contact
Status	Active, not recruiting
Phase
Start date	February 20, 2022
Completion date	August 10, 2022

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms