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

• ClinicalTrials.gov Identifier: NCT03992937
• Recruitment Status: Completed
• First Posted: June 20, 2019
• Last Update Posted: December 2, 2020
• Sponsor: Kocaeli University
• Information provided by (Responsible Party): Şener Gezer, Kocaeli University

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	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.

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: June 20, 2019
• Actual Primary Completion Date: December 1, 2020
• Actual Study Completion Date: December 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 Name: Mirena

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Turkey

Kocaeli University

Kocaeli, Turkey, 41380

Sponsors and Collaborators

Kocaeli University

Investigators

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

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Şener Gezer, Principal Investigator, Kocaeli University
• ClinicalTrials.gov Identifier: NCT03992937
• Other Study ID Numbers: VMP vs LNG
• First Posted: June 20, 2019
• Last Update Posted: December 2, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Endometrial Hyperplasia; Hyperplasia; Pathologic Processes; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Levonorgestrel; Progesterone; Progestins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral