Endometrial Hyperplasia Without AtypiaNCT03992937
Vaginal Micronized Progesterone Versus Levonorgestrel for Treatment of Non-atypical Endometrial Hyperplasia
A study testing Vaginal Micronized Progesterone and Levonorgestrel-Intrauterine System in people with Endometrial Hyperplasia Without Atypia, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Endometrial Hyperplasia Without Atypia
- What is being tested?
- Vaginal Micronized Progesterone and Levonorgestrel-Intrauterine System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal Patients
- Patients with histologically confirmed endometrial hyperplasia without atypia
Who cannot join
- Endometrial hyperplasia with atypia
- Endometrial Carcinoma
- Suspected pathology on Physical/Ultrasonographic Examination e.g. fibroids, adnexal abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaginal Micronized Progesterone or Levonorgestrel-releasing Intrauterine System (LNG-IUS) for Treatment of Non-atypical Endometrial Hyperplasia: A Prospective Randomized Trial
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.
Read the 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.
- Conditions
- Endometrial Hyperplasia Without Atypia
- Being tested
- Vaginal Micronized Progesterone, Levonorgestrel-Intrauterine System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Levonorgestrel-Intrauterine SystemDevice
Also called Mirena
Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Vaginal Micronized Progesterone |
| LNG-IUS | Active comparator | Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day with one year follow up. Receives: Device: Levonorgestrel-Intrauterine System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 month
Secondary outcomes (2)
Mean Reduction From Baseline in Menstrual Blood Loss
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
Measured: 6 month
Number of Participants with adverse events associated with medication and device
Any side effects will be recorded into questionnaire during a consultation with the patient
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start20 Jun 2019
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endometrial Hyperplasia Without AtypiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şener Gezer, Kocaeli University
- Investigators
- Şener Gezer, M.D, Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992937
- Sponsor's protocol ID
- VMP vs LNG
- Status last verified
- Dec 2020
- First submitted
- 14 Jun 2019
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24488582Gezer 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.
PubMed 36527262Mittermeier 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.
PubMed 32909630
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Micronized Progesterone or Levonorgestrel-releasing Intrauterine System (LNG-IUS) for Treatment of Non-atypical Endometrial Hyperplasia: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03992937
- Acronym / sponsor ID
- VMP vs LNG
- Conditions
- Endometrial Hyperplasia Without Atypia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Micronized Progesterone | Experimental | Drug: Vaginal Micronized ProgesteroneMicronized 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 |
| LNG-IUS | Active comparator | Device: Levonorgestrel-Intrauterine SystemRelease rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day with one year follow up. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Premenopausal Patients
- Patients with histologically confirmed endometrial hyperplasia without atypia
Key exclusion criteria (3 listed)
- Endometrial hyperplasia with atypia
- Endometrial Carcinoma
- Suspected pathology on Physical/Ultrasonographic Examination e.g. fibroids, adnexal abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal Micronized ProgesteroneMicronized 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. | Drug | Vaginal Micronized Progesterone |
| Levonorgestrel-Intrauterine SystemAlso: MirenaRelease rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day. | Device | LNG-IUS |
Primary outcome
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.
2 secondary outcomes
Mean Reduction From Baseline in Menstrual Blood Loss
Time frame: 6 month
Number of Participants with adverse events associated with medication and device
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Background: PubMed 24488582Tasci 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.
- Derived from this study: PubMed 36527262Gezer 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.
- Derived from this study: PubMed 32909630Mittermeier 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.
- Individual participant dataSharing planned: No
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Atypical Endometrial Hyperplasia, FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
Active, not recruitingPhase 2
Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şener Gezer, M.D principal investigator
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal Micronized Progesterone and Levonorgestrel-Intrauterine System in people with Endometrial Hyperplasia Without Atypia, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression and remission rate of endometrial hyperplasia (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03992937, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.