Hemoglobin; DeficiencyNCT06935968
Effect of Levonorgestrel Intrauterine System on Hemoglobin Level
A study testing Levonorgestrel intrautrine system in people with Hemoglobin; Deficiency, run by Assiut University.
Trial summary
To study the effect of LNG-IUS on improving iron status in reproductive-aged women presenting for contraception. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hemoglobin; Deficiency
- What is being tested?
- Levonorgestrel intrautrine system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The study will include married women attending the outpatient clinics of the forementioned health facilities for contraception counseling
- Age between 18 and 45 years
- Women who choose LNG_IUS for contraception
- Any parity including nulliparous
Who cannot join
- 1.Women with any inherited hemoglobinopathy (thalassemia, sickle cell anemia) or acquired hemolytic anemia 2.Women with sever iron deficiency anemia requiring immediate treatment 3.Women with any contraindication to Mirena insertion (pelvic inflammatory disease, cervical or vaginal infection, cervical cancer) 4. Any uterine abnormality making LNG_IUS insertion difficult (septate uterus or fibroid distorting the cavity) 5. Women within 6 months of delivery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Essam eldeen Rashad contact
About this study
Official title: Effect of Levonorgestrel Intrautrine System on Hemoglobin Level and Iron Profile on Women Requiring Contraception
To study the effect of LNG-IUS on improving iron status in reproductive-aged women presenting for contraception.
Read the detailed description
Women come to family planning clinic to insert levonorgestrel intrautrine system and take a blood sample from her to analyse hemoglobin level
- Conditions
- Hemoglobin; Deficiency
- Being tested
- Levonorgestrel intrautrine system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel intrautrine systemDevice
Also called Take a blood sample
Insertion of levonorgestrel intrautrine system and take a blood sample from the women to analyse it
| Study group | Role | What they receive |
|---|---|---|
| Levonorgestrel intrauterine system insertion | Other | Not described Receives: Device: Levonorgestrel intrautrine system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of blood haemoglobin level from time of insertion to 6 months after insertion
To know the effect of LNG-IUDs on hemoglobin level after insertion
Measured: 6 months
Secondary outcomes (1)
Change of serum ferritin level from time of insertion to 6 months after insertionPrevalence of iron deficiency and iron deficiency anemia in women requiring contraception in our community
To know the effect of LNG-IUDs in serum ferritin
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 posted20 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemoglobin; DeficiencyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Melad Matta, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935968
- Sponsor's protocol ID
- Mirena
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Levonorgestrel Intrautrine System on Hemoglobin Level and Iron Profile on Women Requiring Contraception
- ClinicalTrials.gov ID
- NCT06935968
- Acronym / sponsor ID
- Mirena
- Conditions
- Hemoglobin; Deficiency
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 20 Apr 2025 (actual)
- 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.
To study the effect of LNG-IUS on improving iron status in reproductive-aged women presenting for contraception.
Detailed description
Women come to family planning clinic to insert levonorgestrel intrautrine system and take a blood sample from her to analyse hemoglobin level
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levonorgestrel intrauterine system insertion | Other | Device: Levonorgestrel intrautrine system |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The study will include married women attending the outpatient clinics of the forementioned health facilities for contraception counseling
- Age between 18 and 45 years
- Women who choose LNG_IUS for contraception
- Any parity including nulliparous
Key exclusion criteria (1 listed)
- 1.Women with any inherited hemoglobinopathy (thalassemia, sickle cell anemia) or acquired hemolytic anemia 2.Women with sever iron deficiency anemia requiring immediate treatment 3.Women with any contraindication to Mirena insertion (pelvic inflammatory disease, cervical or vaginal infection, cervical cancer) 4. Any uterine abnormality making LNG_IUS insertion difficult (septate uterus or fibroid distorting the cavity) 5. Women within 6 months of delivery
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 |
|---|---|---|
| Levonorgestrel intrautrine systemAlso: Take a blood sampleInsertion of levonorgestrel intrautrine system and take a blood sample from the women to analyse it | Device | Levonorgestrel intrauterine system insertion |
Primary outcome
Change of blood haemoglobin level from time of insertion to 6 months after insertion
Time frame: 6 months
To know the effect of LNG-IUDs on hemoglobin level after insertion
1 secondary outcome
Change of serum ferritin level from time of insertion to 6 months after insertionPrevalence of iron deficiency and iron deficiency anemia in women requiring contraception in our community
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
Related trials for Hemoglobin; Deficiency
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Alternate-Day vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA)
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Reticulocyte Hemoglobin Equivalent (RET-He) in Early Detection of Iron Deficiency Among Blood Donors and Its Potential Impact on Donor Eligibility and Transfusion Safety
Iron Deficiency, Latent Iron Deficiency
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Menstruation and Anemia Research: A Community Health Study
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Impact of Iron Supplementation During Pregnancy
Anemia, Iron Deficiency Anaemia in Childbirth
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Iron-Rich Snack Intervention for Anemia in Adolescent Girls
Iron Deficiency Anemia (IDA)
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.
Essam eldeen Rashad contact
Questions about this trial
What is this clinical trial studying?
A study testing Levonorgestrel intrautrine system in people with Hemoglobin; Deficiency, run by Assiut University.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariam Melad (01020214925, mariomamelad8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of blood haemoglobin level from time of insertion to 6 months after insertion (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 20 Apr 2025.