Clinical trial NCT02326922: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dysfunctional Uterine Bleeding
Keywords: Dysfunctional uterine bleeding
Metraplant-E
Levonorgestrel-releasing intrauterine device
Endometrial decidualization
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2014-12-30
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Amount of menstrual blood loss (MBL) in women with menorrhagia by means of pictorial bleeding assesment chart
timeFrame: 6 months
Secondary outcomes:
measure: Histological changes in Endometrial biopsy prior to and 6 months after the insertion of the intrauterine system (Metraplant-E)
timeFrame: 6 months
measure: Hemoglobin level in blood prior to the device insertion and 6 months afterwards
timeFrame: 6 months
Other outcomes:
measure: The degree of patient satisfaction and acceptability of treatment Metraplant-E intrauterine device for the patients with dysfunctional uterine bleeding.
timeFrame: 6 months
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
affiliation: Ain Shams University Faculty of Medicine
name: Mohamed Azzam, MD
role: STUDY_DIRECTOR
References: