NCT02326922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 30, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 14, 2016

Status Verified

March 1, 2016

Enrollment Period

1.7 years

First QC Date

June 29, 2014

Last Update Submit

March 11, 2016

Conditions

Dysfunctional Uterine Bleeding

Keywords

Dysfunctional uterine bleedingMetraplant-ELevonorgestrel-releasing intrauterine deviceEndometrial decidualization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Histological changes in Endometrial biopsy prior to and 6 months after the insertion of the intrauterine system (Metraplant-E)

    6 months

  • Hemoglobin level in blood prior to the device insertion and 6 months afterwards

    6 months

Other Outcomes (1)

  • The degree of patient satisfaction and acceptability of treatment Metraplant-E intrauterine device for the patients with dysfunctional uterine bleeding.

    6 months

Study Arms (2)

Metraplant-E First prototype

EXPERIMENTAL

Metraplant-E (first prototype) levonorgestrel-releasing intrauterine device

Device: Metraplant-E levonorgestrel-releasing intrauterine device

Metraplant-E second prototype

EXPERIMENTAL

Metraplant-E (second prototype) levonorgestrel-releasing intrauterine device

Device: Metraplant-E levonorgestrel-releasing intrauterine device

Interventions

Metraplant-E levonorgestrel-releasing intrauterine deviceDEVICE

Metraplant-E insertion and follow up for 6 months

Metraplant-E First prototypeMetraplant-E second prototype

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women seeking contraception.
  • Women with history of menorrhagia.
  • Pre and perimenopausal women who are married or previously married.
  • Failure of other medical treatment to control menorrhagia such as hemostatics.
  • Women who did not tolerate copper IUD due to increased amount of menstrual blood loss which could lead to anemia.

You may not qualify if:

  • History of ectopic pregnancy .
  • Pregnancy or suspicion of pregnancy.
  • Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity.
  • Acute pelvic inflammatory disease
  • Postpartum endometritis or infected abortion in the past 3 months.
  • Known or suspected uterine or cervical neoplasia or unresolved, abnormal Pap smear.
  • Genital bleeding of unknown etiology.
  • Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections, until infection is controlled.
  • Acute liver disease or liver tumor (benign or malignant).
  • 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.
  • A previously inserted IUD that has not been removed.
  • Hypersensitivity to any component of this product.
  • Women taking anticoagulants
  • Women with coagulopathies due to thrombocytopenia or platelets dysfunction.
  • Known or suspected carcinoma of the breast.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed Azzam, MD

    Ain Shams University Faculty of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Obgyn resident

Study Record Dates

First Submitted

June 29, 2014

First Posted

December 30, 2014

Study Start

June 1, 2014

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

March 14, 2016

Record last verified: 2016-03

Locations

EG(1)