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

Abnormal Uterine Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05474703
• Other study ID #: Duphastonversusmirena
• Status: Active, not recruiting
• Start date: February 20, 2022
• Est. completion date: August 10, 2022

Study information

• Verified date: July 2022
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 171
• Est. completion date: August 10, 2022
• Est. primary completion date: July 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding
• Hemorrhage
• Uterine Hemorrhage

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Pinar Yalcin Bahat	Istanbul	I?stanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Form- 36 scores (SF-36)	The difference in quality of life between the two groups will be evaluated with the SF-36 scale.	6 months
Secondary	The Female Sexual Function Index FSFI scores	Sexual life quality difference between the two groups will be evaluated with the FSFI scale.	6 months