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

Sponsor

Kocaeli University (Other)

Overall Status

Completed

CT.gov ID

NCT03992937

Collaborator

(none)

132

Enrollment

Location

Arms

17.4

Actual Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Actual 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 :

Jun 20, 2019

Actual Primary Completion Date :

Dec 1, 2020

Actual Study Completion Date :

Dec 1, 2020

Arms and Interventions

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 Names: Mirena

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 Names:

Mirena

Outcome Measures

Primary Outcome Measures

Regression and remission rate of endometrial hyperplasia [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

Mean Reduction From Baseline in Menstrual Blood Loss [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 [6 month]
Any side effects will be recorded into questionnaire during a consultation with the patient

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kocaeli University	Kocaeli		Turkey	41380

Sponsors and Collaborators

Kocaeli University

Investigators

Principal Investigator: Şener Gezer, M.D, Kocaeli University

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Şener Gezer, Principal Investigator, Kocaeli University

ClinicalTrials.gov Identifier:

NCT03992937

Other Study ID Numbers:

VMP vs LNG

First Posted:

Jun 20, 2019

Last Update Posted:

Dec 2, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endometrial Hyperplasia

Hyperplasia

Levonorgestrel

Progesterone

Study Results

No Results Posted as of Dec 2, 2020