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Trial record 10 of 404 for:    LEVONORGESTREL

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
Sponsor:
Information provided by (Responsible Party):
Şener Gezer, Kocaeli University

Brief Summary:
The purpose of this study is to compare the efficacy of the vaginal micronized progesterone and Levonorgestrel-releasing Intrauterine System for treatment of non-atypical endometrial hyperplasia in premenopausal women.

Condition or disease Intervention/treatment Phase
Endometrial Hyperplasia Without Atypia Drug: Vaginal Micronized Progesterone Device: Levonorgestrel-Intrauterine System Not Applicable

Detailed Description:
Vaginal use of micronized progesterone in the treatment of endometrial hyperplasia can result in better than oral administration, as it will remain away from the first pass effect, and depending on the local application. In this study, we aimed to compare this local treatment with Levonorgestrel-releasing Intrauterine System for treatment of non-atypical endometrial hyperplasia.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Premenopausal Patients
  • Patients with histologically confirmed endometrial hyperplasia without atypia

Exclusion Criteria:

  • Endometrial hyperplasia with atypia
  • Endometrial Carcinoma
  • Suspected pathology on Physical/Ultrasonographic Examination e.g. fibroids, adnexal abnormality

Information from the National Library of Medicine

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


Contacts
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Contact: Şener Gezer, M.D +902623037039 dr.senergezer@gmail.com

Locations
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Turkey
Kocaeli University Recruiting
Kocaeli, Turkey, 41380
Contact: Şener Gezer    2623037039    dr.senergezer@gmail.com   
Sponsors and Collaborators
Kocaeli University
Investigators
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Principal Investigator: Şener Gezer, M.D Kocaeli University

Publications:
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Responsible Party: Şener Gezer, Principal Investigator, Kocaeli University
ClinicalTrials.gov Identifier: NCT03992937     History of Changes
Other Study ID Numbers: VMP vs LNG
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Levonorgestrel
Endometrial Hyperplasia
Hyperplasia
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral