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

Sponsor
Kanuni Sultan Suleyman Training and Research Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05474703
Collaborator
(none)
171
1
5.6
30.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
171 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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.
Actual Study Start Date :
Feb 20, 2022
Actual Primary Completion Date :
Jul 24, 2022
Anticipated Study Completion Date :
Aug 10, 2022

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. Short Form- 36 scores (SF-36) [6 months]

      The difference in quality of life between the two groups will be evaluated with the SF-36 scale.

    Secondary Outcome Measures

    1. The Female Sexual Function Index FSFI scores [6 months]

      Sexual life quality difference between the two groups will be evaluated with the FSFI scale.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pinar Yalcin Bahat Istanbul İ̇stanbul Turkey 34000

    Sponsors and Collaborators

    • Kanuni Sultan Suleyman Training and Research Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pınar Yalcin bahat, Principial investigator, Kanuni Sultan Suleyman Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT05474703
    Other Study ID Numbers:
    • Duphastonversusmirena
    First Posted:
    Jul 26, 2022
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pınar Yalcin bahat, Principial investigator, Kanuni Sultan Suleyman Training and Research Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 29, 2022