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

NCT05474703 | Unknown

• 1 other identifier: Duphastonversusmirena
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Abnormal Uterine Bleeding

Keywords

Dydrogesterone; Levonorgestrel; Abnormal Uterine Bleeding; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The Female Sexual Function Index FSFI scores

  6 months

Study Arms (2)

AUK with Dydrogestrone

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

Other: SF-36 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

Interventions

SF-36 Scores 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.

Also known as: FSFI scores

AUK with Dydrogestrone; AUK with Levonorgestrel releasing intrauterin device

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Pinar Yalcin Bahat

Istanbul, İ̇stanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principial investigator

Study Record Dates

• First Submitted: July 23, 2022
• First Posted: July 26, 2022
• Study Start: February 20, 2022
• Primary Completion: July 24, 2022
• Study Completion: August 10, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Locations

TU (1)