Vaginal Micronized Progesterone Versus Levonorgestrel for Treatment of Non-atypical Endometrial Hyperplasia
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|ClinicalTrials.gov Identifier: NCT03992937|
Recruitment Status : Recruiting
First Posted : June 20, 2019
Last Update Posted : June 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Hyperplasia Without Atypia||Drug: Vaginal Micronized Progesterone Device: Levonorgestrel-Intrauterine System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Vaginal Micronized Progesterone or Levonorgestrel-releasing Intrauterine System (LNG-IUS) for Treatment of Non-atypical Endometrial Hyperplasia: A Prospective Randomized Trial|
|Actual Study Start Date :||June 20, 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Vaginal Micronized Progesterone
Micronized progesterone tablets at a dose of 200 mg once a day vaginally, for 12 days (Between 14'th-25'th days of the menstrual cycle) over three months. With persistence of endometrial hyperplasia, the treatment is repeated for another 3 months
Drug: Vaginal Micronized Progesterone
Micronized progesterone tablets at a dose of 200 mg once a day vaginally, for 12 days (Between 14'th-25'th days of the menstrual cycle) over three months.
Active Comparator: LNG-IUS
Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day with one year follow up.
Device: Levonorgestrel-Intrauterine System
Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day.
Other Name: Mirena
- Regression and remission rate of endometrial hyperplasia [ Time Frame: 3 month ]Endometrial sampling will be performed for 3'th month with Carmen canula. Pathological specimens will be reported by the specialist pathologist in accordance with the World Health Organisation (WHO) endometrial hyperplasia classification.
- Mean Reduction From Baseline in Menstrual Blood Loss [ Time Frame: 6 month ]Menorrhagia Impact Questionnaire (MIQ). This is a validated disease-specific patient-reported outcome questionnaire assessing menstrual blood loss and the influence of heavy menstrual bleeding on quality of life
- Number of Participants with adverse events associated with medication and device [ Time Frame: 6 month ]Any side effects will be recorded into questionnaire during a consultation with the patient
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03992937
|Contact: Şener Gezer, M.Demail@example.com|
|Kocaeli, Turkey, 41380|
|Contact: Şener Gezer 2623037039 firstname.lastname@example.org|
|Principal Investigator:||Şener Gezer, M.D||Kocaeli University|