Dysfunctional Uterine BleedingPhase 1/2NCT02326922
The Use of Levonorgestrel-Releasing Device (Metraplant-E) in the Treatment of Dysfunctional Uterine Bleeding
A Phase 1/2 study testing Metraplant-E levonorgestrel-releasing intrauterine device in people with Dysfunctional Uterine Bleeding, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Dysfunctional Uterine Bleeding
- What is being tested?
- Metraplant-E levonorgestrel-releasing intrauterine device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2014to Mar 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- Endometrial biopsy prior to and 6 months after the insertion of the intrauterine system (Metraplant-E).
- Haemoglobin level measurement in gm/dl and serum ferritin level on same occasions as when endometrial biopsy is done.
- 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:
- 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 (intrauterine device) due to increased amount of menstrual blood loss which could lead to anemia.
- Conditions
- Dysfunctional Uterine Bleeding
- Being tested
- Metraplant-E levonorgestrel-releasing intrauterine device
- Keywords
- Dysfunctional uterine bleeding, Metraplant-E, Levonorgestrel-releasing intrauterine device, Endometrial decidualization
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metraplant-E levonorgestrel-releasing intrauterine deviceDevice
Metraplant-E insertion and follow up for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Metraplant-E First prototype | Experimental | Metraplant-E (first prototype) levonorgestrel-releasing intrauterine device Receives: Device: Metraplant-E levonorgestrel-releasing intrauterine device |
| Metraplant-E second prototype | Experimental | Metraplant-E (second prototype) levonorgestrel-releasing intrauterine device Receives: Device: Metraplant-E levonorgestrel-releasing intrauterine device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
Histological changes in Endometrial biopsy prior to and 6 months after the insertion of the intrauterine system (Metraplant-E)
to observe the effects of the intrauterine-released levonorgestrel on the endometrium after 6 months after the insertion of the device
Measured: 6 months
Hemoglobin level in blood prior to the device insertion and 6 months afterwards
and to assess the effect on general condition of the patient by following up the haemoglobin level.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunctional Uterine BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshaimaa Ahmad Aboulfetouh Mahmoud, Ain Shams Maternity Hospital
- Investigators
- Mohamed Azzam, MD, Study director, Ain Shams University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326922
- Sponsor's protocol ID
- AAAM1983
- Status last verified
- Mar 2016
- First submitted
- 29 Jun 2014
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Levonorgestrel-Releasing Device (Metraplant-E) in the Treatment of Dysfunctional Uterine Bleeding
- ClinicalTrials.gov ID
- NCT02326922
- Acronym / sponsor ID
- AAAM1983
- Conditions
- Dysfunctional Uterine Bleeding
- Keywords
- Dysfunctional uterine bleeding, Metraplant-E, Levonorgestrel-releasing intrauterine device, Endometrial decidualization
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Endometrial biopsy prior to and 6 months after the insertion of the intrauterine system (Metraplant-E).
- Haemoglobin level measurement in gm/dl and serum ferritin level on same occasions as when endometrial biopsy is done.
- 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:
- 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 (intrauterine device) due to increased amount of menstrual blood loss which could lead to anemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metraplant-E First prototype | Experimental | Device: Metraplant-E levonorgestrel-releasing intrauterine deviceMetraplant-E (first prototype) levonorgestrel-releasing intrauterine device |
| Metraplant-E second prototype | Experimental | Device: Metraplant-E levonorgestrel-releasing intrauterine deviceMetraplant-E (second prototype) levonorgestrel-releasing intrauterine device |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metraplant-E levonorgestrel-releasing intrauterine deviceMetraplant-E insertion and follow up for 6 months | Device | Metraplant-E First prototype, Metraplant-E second prototype |
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.
2 secondary outcomes
Histological changes in Endometrial biopsy prior to and 6 months after the insertion of the intrauterine system (Metraplant-E)
Time frame: 6 months
Hemoglobin level in blood prior to the device insertion and 6 months afterwards
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Azzam, MD study director
Ain Shams University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Metraplant-E levonorgestrel-releasing intrauterine device in people with Dysfunctional Uterine Bleeding, run by Ain Shams Maternity Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of menstrual blood loss (MBL) in women with menorrhagia by means of pictorial bleeding assesment chart (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.