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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Abnormal Uterine Bleeding
• Intervention / Treatment: Other: SF-36 Scores

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.

• Study Type: Observational
• Enrollment (Actual): 171

Contacts and Locations

Study Locations

• Turkey
  • İ̇stanbul
    • Istanbul, İ̇stanbul, Turkey, 34000
      • Pinar Yalcin Bahat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AUK with Dydrogestrone; Patients who applied for abnormal uterine bleeding and received oral dydrogesterone therapy for at least 6 months	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.; Other Names: FSFI scores
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	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.; Other Names: FSFI scores

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Female Sexual Function Index FSFI scores	Sexual life quality difference between the two groups will be evaluated with the FSFI scale.	6 months

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2022
• Primary Completion (Actual): July 24, 2022
• Study Completion (Anticipated): August 10, 2022

Study Registration Dates

• First Submitted: July 23, 2022
• First Submitted That Met QC Criteria: July 23, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Quality of life; Levonorgestrel; Abnormal Uterine Bleeding; Dydrogesterone
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Uterine Hemorrhage
• Other Study ID Numbers: Duphastonversusmirena

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No