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Effect of two different doses on hematological parameters in perimenopausal anemic women with heavy menstrual bleeding: A Randomized controlled trial

Effect of intravenous Ferric carboxy maltose and Iron sucrose on hematological parameters in perimenopausal anemic women with heavy menstrual bleeding: A Randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/013854
Enrollment
60
Registered
2018-05-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Abnormal Uterine Bleeding

Interventions

Intervention1: IV iron carboxymaltose: Group 1 Will receive IV iron carboxymaltose. Maximal dose in a single day 15mg/kg, not to exceed 1000mg. Subsequent doses on day 7 and day 14. Drug diluted in 25

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Serum Hb >6g/dl and 2) Perimenopausal women in the age group of 40-51 years with anemia due to Heavy Menstrual Bleeding. 3) Not tolerating oral iron

Exclusion criteria

Exclusion criteria: 1) Age less than 40 years and more than 51 years 2) Anemia due to causes other than iron deficiency anemia 3) Chronic infections like hepatitis and HIV 4) Serum transaminase level greater than 1.5 times the upper limit of normal 5) Serum creatinine level of more than 2.0mg/dl 6) Patients with history of allergic reaction to intravenous iron infusion

Design outcomes

Primary

MeasureTime frame
â?¢ Rise in Hb levels / reticulocyte count above baseline, rate of rise in Hb in reference with timeTimepoint: 3 months

Secondary

MeasureTime frame
â?¢ Proportions of people acheieving normalisation of Hb (10.9g/dL) â?¢ Rise in serum ferritin and serum iron Timepoint: 3 months

Countries

India

Contacts

Public ContactDr k Rupendra
jaya_sunil@yahoo.com9917051626

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026