Clinical trial NCT05474703: Evaluation of the Effects of Levonorgestrel-releasing Intrauterine Device and Dydrogestreone on Quality of Life and Sexual Life in Patients With Abnormal Uterine Bleeding.
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abnormal Uterine Bleeding
Keywords: Dydrogesterone
Levonorgestrel
Abnormal Uterine Bleeding
Quality of life
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 171
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Short Form- 36 scores (SF-36)
timeFrame: 6 months
Secondary outcomes:
measure: The Female Sexual Function Index FSFI scores
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pinar Yalcin Bahat
state: İ̇stanbul
Study officials:
References: