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

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.

Study Overview

• Status: Completed
• Conditions: Dysfunctional Uterine Bleeding
• Intervention / Treatment: Device: Metraplant-E levonorgestrel-releasing intrauterine device

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The degree of patient satisfaction and acceptability of treatment Metraplant-E intrauterine device 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

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Investigators: Study Director: Mohamed Azzam, MD, Ain Shams University Faculty Of Medicine

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: June 29, 2014
• First Submitted That Met QC Criteria: December 29, 2014
• First Posted (Estimate): December 30, 2014

Study Record Updates

• Last Update Posted (Estimate): March 14, 2016
• Last Update Submitted That Met QC Criteria: March 11, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Dysfunctional uterine bleeding; Metraplant-E; Levonorgestrel-releasing intrauterine device; Endometrial decidualization
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Metrorrhagia; Uterine Hemorrhage; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: AAAM1983

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED