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Status unknownNCT05474703Updated Jul 29, 2022

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

An observational study in Abnormal Uterine Bleeding, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Status unknown at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-29.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
171
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Abnormal Uterine Bleeding

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Keywords

  • Dydrogesterone
  • Levonorgestrel
  • Abnormal Uterine Bleeding
  • Quality of life
03

In context

Metrorrhagia

103 studies on the registry are indexed under Metrorrhagia; 27 are open to participants now.

This study's enrollment of 171 is below the median of 202 across 21 observational studies indexed under Metrorrhagia.

Browse Metrorrhagia studies →

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 224 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
171 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • OtherSF-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.

    Also known as: FSFI scores

06

What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

  1. The Female Sexual Function Index FSFI scores

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

    Time frame: 6 months

07

Study locations

1 site
  • Pinar Yalcin Bahat
    Istanbul, İ̇stanbul 34000, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2022 to primary completion in Jul 2022, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2022
First posted
Jul 26, 2022
StartActual
Feb 20, 2022
Primary completionActual
Jul 24, 2022
CompletionEst.
Aug 10, 2022
Last update
Jul 29, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05474703
Responsible party
Pınar Yalcin bahat (Principial investigator, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Jul 26, 2022
Start date
Feb 20, 2022
Primary completion
Jul 24, 2022
Completion
Aug 10, 2022 (estimated)
Last update
Jul 29, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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