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

NCT ID: NCT02326922

Last Updated: 2016-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-03-31

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:

1. Women seeking contraception.

2. Women with history of menorrhagia.

3. Pre and perimenopausal women who are married or previously married.

4. Failure of other medical treatment to control menorrhagia such as hemostatics.

5. Women who did not tolerate copper IUD (intrauterine device) due to increased amount of menstrual blood loss which could lead to anemia.

Conditions

Dysfunctional Uterine Bleeding

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metraplant-E First prototype

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

Group Type: EXPERIMENTAL

Metraplant-E levonorgestrel-releasing intrauterine device

Intervention Type: DEVICE

Metraplant-E insertion and follow up for 6 months

Metraplant-E second prototype

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

Group Type: EXPERIMENTAL

Metraplant-E levonorgestrel-releasing intrauterine device

Intervention Type: DEVICE

Metraplant-E insertion and follow up for 6 months

Interventions

Metraplant-E levonorgestrel-releasing intrauterine device

Metraplant-E insertion and follow up for 6 months

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Women seeking contraception.

2. Women with history of menorrhagia.

3. Pre and perimenopausal women who are married or previously married.

4. Failure of other medical treatment to control menorrhagia such as hemostatics.

5. Women who did not tolerate copper IUD due to increased amount of menstrual blood loss which could lead to anemia.

Exclusion Criteria

1. History of ectopic pregnancy .

2. Pregnancy or suspicion of pregnancy.

3. Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity.

4. Acute pelvic inflammatory disease

5. Postpartum endometritis or infected abortion in the past 3 months.

6. Known or suspected uterine or cervical neoplasia or unresolved, abnormal Pap smear.

7. Genital bleeding of unknown etiology.

8. Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections, until infection is controlled.

9. Acute liver disease or liver tumor (benign or malignant).

10. 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.

11. A previously inserted IUD that has not been removed.

12. Hypersensitivity to any component of this product.

13. Women taking anticoagulants

14. Women with coagulopathies due to thrombocytopenia or platelets dysfunction.

15. Known or suspected carcinoma of the breast.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams Maternity Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alshaimaa Ahmad Aboulfetouh Mahmoud

Obgyn resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Azzam, MD

Role: STUDY_DIRECTOR

Ain Shams University Faculty of Medicine

Locations

Ain Shams Maternity Hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

AAAM1983

Identifier Type: -

Identifier Source: org_study_id