NCT03992937

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

June 20, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 2, 2020

Status Verified

December 1, 2020

Enrollment Period

1.5 years

First QC Date

June 14, 2019

Last Update Submit

December 1, 2020

Conditions

Endometrial Hyperplasia Without Atypia

Outcome Measures

Primary Outcomes (1)

  • Regression and remission rate of endometrial hyperplasia

    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.

    3 month

Secondary Outcomes (2)

  • Mean Reduction From Baseline in Menstrual Blood Loss

    6 month

  • Number of Participants with adverse events associated with medication and device

    6 month

Study Arms (2)

Vaginal Micronized Progesterone

EXPERIMENTAL

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

LNG-IUS

ACTIVE COMPARATOR

Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day with one year follow up.

Device: Levonorgestrel-Intrauterine System

Interventions

Vaginal Micronized ProgesteroneDRUG

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.

Vaginal Micronized Progesterone
Levonorgestrel-Intrauterine SystemDEVICE

Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day.

Also known as: Mirena
LNG-IUS

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

Location

Related Publications (3)

  • Tasci Y, Polat OG, Ozdogan S, Karcaaltincaba D, Seckin L, Erkaya S. Comparison of the efficacy of micronized progesterone and lynestrenol in treatment of simple endometrial hyperplasia without atypia. Arch Gynecol Obstet. 2014 Jul;290(1):83-6. doi: 10.1007/s00404-014-3161-4. Epub 2014 Feb 1.

    PMID: 24488582BACKGROUND

  • Gezer S, Kole E, Aksoy L. Vaginal micronized progesterone versus the levonorgestrel-releasing intrauterine system for treatment of non-atypical endometrial hyperplasia: A randomized controlled trial. Int J Gynaecol Obstet. 2023 May;161(2):661-666. doi: 10.1002/ijgo.14632. Epub 2023 Jan 12.

    PMID: 36527262DERIVED

  • Mittermeier T, Farrant C, Wise MR. Levonorgestrel-releasing intrauterine system for endometrial hyperplasia. Cochrane Database Syst Rev. 2020 Sep 6;9(9):CD012658. doi: 10.1002/14651858.CD012658.pub2.

    PMID: 32909630DERIVED

Study Officials

  • Şener Gezer, M.D

    Kocaeli University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 14, 2019

First Posted

June 20, 2019

Study Start

June 20, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

December 2, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)