evonorgestrel Intrauterine System effect on Anemia: LISA Trial
- Conditions
- Haematological Disorders
- Registration Number
- PACTR202206713343239
- Lead Sponsor
- FHI 360
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 600
Prospective participants must meet the following main criteria:
1.Provide sequential oral and written consents to screen for eligibility and enroll
2.Female, aged 18-50
3.Desire to use contraception or possibly switch methods
4.Initial hemoglobin of < 126 g/L
5.Possession of a cell phone and willingness to be contacted
6.Confirmatory low hemoglobin (minimum of 87 g/L and maximum of 126 g/L) taken 1 to 4 weeks after the initial test
7.Regularly menstruating (at least once every 35 days)
8.At least 6 weeks postpartum
9.Willingness to agree to study procedures
10.Willingness to be randomized to treatment
11.Willingness to use assigned hormonal contraceptive for 18 months
An individual who has any of the following will be excluded from participation in this study:
1.Severe anemia (hemoglobin < 86 g/L), based on the second rapid test
2.Currently pregnant based on urine pregnancy test and failure to rule out possible pregnancy according to WHO guidelines (75)
3.Surgically sterilized or had a hysterectomy
4.Participated previously in this study by being randomized to contraceptive
5.Currently using a subdermal contraceptive implant and does not wish to have it removed
6.Currently using an LNG IUS
7.Currently receiving treatment for anemia
8.Any of the following previously diagnosed disorders: hemosiderosis, hemochromatosis, hemolytic anemia
9.Known allergic reactions to oral contraceptives or LNG IUS
10.Currently receiving an investigational (unapproved) drug in another study
11.Any condition (social or medical) which in the opinion of the investigator would make study participation unsafe
12.Intending to become pregnant in the next 18 months
13.Mucopurulent cervicitis
14.Pelvic inflammatory disease
15.Other medical contraindications to treatment, according to WHO Medical Eligibility Criteria (categories 3 or 4)(9)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in hemoglobin
- Secondary Outcome Measures
Name Time Method Serum ferritin changes over time in the randomized arms