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

Primary Purpose

Dysfunctional Uterine Bleeding

Status

Completed

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

Metraplant-E levonorgestrel-releasing intrauterine device

About this trial

This is an interventional treatment trial for Dysfunctional Uterine Bleeding focused on measuring Dysfunctional uterine bleeding, Metraplant-E, Levonorgestrel-releasing intrauterine device, Endometrial decidualization

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Ain Shams Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Metraplant-E First prototype

Metraplant-E second prototype

Arm Description

Metraplant-E (first prototype) levonorgestrel-releasing intrauterine device

Metraplant-E (second prototype) levonorgestrel-releasing intrauterine device

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT02326922

First Posted

June 29, 2014

Last Updated

March 11, 2016

Sponsor

Ain Shams Maternity Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02326922

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams Maternity Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dysfunctional Uterine Bleeding

Keywords

Dysfunctional uterine bleeding, Metraplant-E, Levonorgestrel-releasing intrauterine device, Endometrial decidualization

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metraplant-E First prototype

Arm Type

Experimental

Arm Description

Metraplant-E (first prototype) levonorgestrel-releasing intrauterine device

Arm Title

Metraplant-E second prototype

Arm Type

Experimental

Arm Description

Metraplant-E (second prototype) levonorgestrel-releasing intrauterine device

Intervention Type

Device

Intervention Name(s)

Metraplant-E levonorgestrel-releasing intrauterine device

Intervention Description

Metraplant-E insertion and follow up for 6 months

Primary Outcome Measure Information:

Title

Amount of menstrual blood loss (MBL) in women with menorrhagia by means of pictorial bleeding assesment chart

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Histological changes in Endometrial biopsy prior to and 6 months after the insertion of the intrauterine system (Metraplant-E)

Description

to observe the effects of the intrauterine-released levonorgestrel on the endometrium after 6 months after the insertion of the device

Time Frame

6 months

Title

Hemoglobin level in blood prior to the device insertion and 6 months afterwards

Description

and to assess the effect on general condition of the patient by following up the haemoglobin level.

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

The degree of patient satisfaction and acceptability of treatment Metraplant-E intrauterine device for the patients with dysfunctional uterine bleeding.

Description

This will be conducted through a questionnaire offered to the women participating in this study which is designed on Likert scale.

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed Azzam, MD

Organizational Affiliation

Ain Shams University Faculty of Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Ain Shams Maternity Hospital

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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