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Trial record 16 of 408 for:    LEVONORGESTREL

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

Tracking Information
First Submitted Date  ICMJE June 29, 2014
First Posted Date  ICMJE December 30, 2014
Last Update Posted Date March 14, 2016
Study Start Date  ICMJE June 2014
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2015)
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 Measures  ICMJE
 (submitted: December 29, 2014)
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.
Change History Complete list of historical versions of study NCT02326922 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2015)
  • 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 Measures  ICMJE
 (submitted: December 29, 2014)
  • 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.
Current Other Pre-specified Outcome Measures
 (submitted: December 29, 2014)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Use of Levonorgestrel-Releasing Device (Metraplant-E) in the Treatment of Dysfunctional Uterine Bleeding
Official Title  ICMJE 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 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dysfunctional Uterine Bleeding
Intervention  ICMJE Device: Metraplant-E levonorgestrel-releasing intrauterine device
Metraplant-E insertion and follow up for 6 months
Study Arms  ICMJE
  • Experimental: Metraplant-E First prototype
    Metraplant-E (first prototype) levonorgestrel-releasing intrauterine device
    Intervention: Device: Metraplant-E levonorgestrel-releasing intrauterine device
  • Experimental: Metraplant-E second prototype
    Metraplant-E (second prototype) levonorgestrel-releasing intrauterine device
    Intervention: Device: Metraplant-E levonorgestrel-releasing intrauterine device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2016)
61
Original Estimated Enrollment  ICMJE
 (submitted: December 29, 2014)
50
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02326922
Other Study ID Numbers  ICMJE AAAM1983
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Alshaimaa Ahmad Aboulfetouh Mahmoud, Ain Shams Maternity Hospital
Study Sponsor  ICMJE Ain Shams Maternity Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mohamed Azzam, MD Ain Shams University Faculty of Medicine
PRS Account Ain Shams Maternity Hospital
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP