The Use of Levonorgestrel-Releasing Device (Metraplant-E) in the Treatment of Dysfunctional Uterine Bleeding

Study Overview
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Brief Summary
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Research hypothesis: Release of levonorgestrel from Metraplant-E levonorgestrel releasing intrauterine contraceptive device is inadequate to be used as a medical line of treatment of dysfunctional uterine bleeding. The investigators aim to evaluate the therapeutic effect of the intrauterine system (Metraplant-E) in the treatment of dysfunctional uterine bleeding.

Detailed Description
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Primary outcome : The investigators aim to evaluate the short term release of levonorgestrel from the Metraplant-E levonorgestrel releasing intrauterine contraceptive devices (IUCDs). This is in a trial to determine to what extent the intrauterine release of levonorgestrel would reduce MBL in women with menorrhagia and if the treatment would increase the body iron stores and the degree of patient satisfaction and acceptability of treatment for the patients with dysfunctional uterine bleeding. This will be conducted through a questionnaire offered to the women participating in this study which is designed on Likert scale. Secondary outcome: 1) Endometrial biopsy prior to and 6 months after the insertion of the intrauterine system (Metraplant-E). 3) Haemoglobin level measurement in gm/dl and serum ferritin level on same occasions as when endometrial biopsy is done. 4) The amount of monthly menstrual blood loss after the insertion the Metraplant-E levonorgestrel releasing intrauterine contraceptive devices using the following scores: bleeding index,total bleeding score and Pictorial blood loss assessment chart (PBAC). Inclusion criteria: Women seeking contraception. Women with history of menorrhagia. Pre and perimenopausal women who are married or previously married. Failure of other medical treatment to control menorrhagia such as hemostatics. Women who did not tolerate copper IUD (intrauterine device) due to increased amount of menstrual blood loss which could lead to anemia.

Official Title
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The Use of Levonorgestrel-Releasing Device (Metraplant-E) in the Treatment of Dysfunctional Uterine Bleeding

Conditions
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Dysfunctional Uterine Bleeding

Intervention / Treatment
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* Device: Metraplant-E levonorgestrel-releasing intrauterine device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women seeking contraception. Women with history of menorrhagia. Pre and perimenopausal women who are married or previously married. Failure of other medical treatment to control menorrhagia such as hemostatics. Women who did not tolerate copper IUD due to increased amount of menstrual blood loss which could lead to anemia. Exclusion Criteria: History of ectopic pregnancy . Pregnancy or suspicion of pregnancy. Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity. Acute pelvic inflammatory disease Postpartum endometritis or infected abortion in the past 3 months. Known or suspected uterine or cervical neoplasia or unresolved, abnormal Pap smear. Genital bleeding of unknown etiology. Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections, until infection is controlled. Acute liver disease or liver tumor (benign or malignant). Conditions associated with increased susceptibility to infections with microorganisms. Such conditions include, but are not limited to, leukemia, acquired immune deficiency syndrome (AIDS), and I.V. drug abuse. A previously inserted IUD that has not been removed. Hypersensitivity to any component of this product. Women taking anticoagulants Women with coagulopathies due to thrombocytopenia or platelets dysfunction. Known or suspected carcinoma of the breast.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metraplant-E First prototype<br>Metraplant-E (first prototype) levonorgestrel-releasing intrauterine device | Device: Metraplant-E levonorgestrel-releasing intrauterine device<br>* Metraplant-E insertion and follow up for 6 months<br>|
| Experimental: Metraplant-E second prototype<br>Metraplant-E (second prototype) levonorgestrel-releasing intrauterine device | Device: Metraplant-E levonorgestrel-releasing intrauterine device<br>* Metraplant-E insertion and follow up for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of menstrual blood loss (MBL) in women with menorrhagia by means of pictorial bleeding assesment chart | This is in a trial to determine to what extent the intrauterine release of levonorgestrel would reduce menstrual blood loss (MBL) in women with menorrhagia and if the treatment would increase the body iron stores and the degree of patient satisfaction and acceptability of treatment for the patients with dysfunctional uterine bleeding. This will be conducted through a questionnaire offered to the women participating in this study which is designed on Likert scale. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological changes in Endometrial biopsy prior to and 6 months after the insertion of the intrauterine system (Metraplant-E) | to observe the effects of the intrauterine-released levonorgestrel on the endometrium after 6 months after the insertion of the device | 6 months | 
| Hemoglobin level in blood prior to the device insertion and 6 months afterwards | and to assess the effect on general condition of the patient by following up the haemoglobin level. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial decidualization, Dysfunctional uterine bleeding, Metraplant-E, Levonorgestrel-releasing intrauterine device