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

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ClinicalTrials.gov Identifier: NCT02326922
Recruitment Status : Completed
First Posted : December 30, 2014
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Alshaimaa Ahmad Aboulfetouh Mahmoud, Ain Shams Maternity Hospital

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.


Condition or disease Intervention/treatment Phase
Dysfunctional Uterine Bleeding Device: Metraplant-E levonorgestrel-releasing intrauterine device Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Levonorgestrel-Releasing Device (Metraplant-E) in the Treatment of Dysfunctional Uterine Bleeding
Study Start Date : June 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Amount of menstrual blood loss (MBL) in women with menorrhagia by means of pictorial bleeding assesment chart [ Time Frame: 6 months ]
    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 :
  1. Histological changes in Endometrial biopsy prior to and 6 months after the insertion of the intrauterine system (Metraplant-E) [ Time Frame: 6 months ]
    to observe the effects of the intrauterine-released levonorgestrel on the endometrium after 6 months after the insertion of the device

  2. Hemoglobin level in blood prior to the device insertion and 6 months afterwards [ Time Frame: 6 months ]
    and to assess the effect on general condition of the patient by following up the haemoglobin level.


Other Outcome Measures:
  1. The degree of patient satisfaction and acceptability of treatment Metraplant-E intrauterine device for the patients with dysfunctional uterine bleeding. [ Time Frame: 6 months ]
    This will be conducted through a questionnaire offered to the women participating in this study which is designed on Likert scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326922


Locations
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Egypt
Ain Shams Maternity Hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
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Study Director: Mohamed Azzam, MD Ain Shams University Faculty of Medicine

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Responsible Party: Alshaimaa Ahmad Aboulfetouh Mahmoud, Obgyn resident, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02326922     History of Changes
Other Study ID Numbers: AAAM1983
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: March 14, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Alshaimaa Ahmad Aboulfetouh Mahmoud, Ain Shams Maternity Hospital:
Dysfunctional uterine bleeding
Metraplant-E
Levonorgestrel-releasing intrauterine device
Endometrial decidualization
Additional relevant MeSH terms:
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Uterine Hemorrhage
Metrorrhagia
Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral