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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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 coul
    Sponsor: Ain Shams Maternity Hospital

    Current Primary Outcome: 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.


    Original Primary Outcome: Menstrual blood loss (MBL) in women with menorrhagia [ 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.


    Current Secondary Outcome:

    • 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
    • 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.


    Original Secondary Outcome:

    • 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
    • Hemoglobin measurement 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.


    Information By: Ain Shams Maternity Hospital

    Dates:
    Date Received: June 29, 2014
    Date Started: June 2014
    Date Completion:
    Last Updated: March 11, 2016
    Last Verified: March 2016