NCT02326922

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Ain Shams Maternity Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysfunctional Uterine Bleeding

Interventions

Type	Name	Description
DEVICE	Metraplant-E levonorgestrel-releasing intrauterine device	Metraplant-E insertion and follow up for 6 months

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-02-01
• Completion: 2016-03-01
• First posted: 2014-12-30
• Last updated: 2016-03-14

Locations

1 site across 1 country: Egypt