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Vaginal Micronized Progesterone Versus Levonorgestrel for Treatment of Non-atypical Endometrial Hyperplasia

NCT ID: NCT03992937

Last Updated: 2020-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-20

Study Completion Date

2020-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Endometrial Hyperplasia Without Atypia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Vaginal Micronized Progesterone

Intervention Type DRUG

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.

LNG-IUS

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

Group Type ACTIVE_COMPARATOR

Levonorgestrel-Intrauterine System

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DRUG

Levonorgestrel-Intrauterine System

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

Intervention Type DEVICE

Other Intervention Names

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Mirena

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Şener Gezer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Şener Gezer, M.D

Role: PRINCIPAL_INVESTIGATOR

Kocaeli University

Locations

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Kocaeli University

Kocaeli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 24488582 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36527262 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32909630 (View on PubMed)

Other Identifiers

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VMP vs LNG

Identifier Type: -

Identifier Source: org_study_id