Health Condition 1: N939- Abnormal uterine and vaginal bleeding, unspecified Health Condition 2: N939- Abnormal uterine and vaginal bleeding, unspecified Health Condition 3: N948- Other specified conditions associated with female genital organs and menstrual cycle
Conditions
Interventions
Intervention1: Tab. Ormeloxifene
: 60 mg
twice a week
orally
for 3 months
followed by
60mg once a week for 3 months
Control Intervention1: Tab. Tranexamic acid: 500 mg
three times a day
orally
d
Sponsors
INDIRA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
Eligibility
Inclusion criteria
Inclusion criteria: Women aged 25-44 years with complaints of menorrhagia and willing to participate in the study
Exclusion criteria
Exclusion criteria: 1.Pregnancy 2,Women who have delivered within the last 1 year 3.Women who have had abortions in the past 3 months 4.Any drug allergy 5.Post menopausal women 6.Fibroid 7.Adenomyosis 8.Endometriosis 9.Cervical dysplasia 10.Endometrial hyperplasia with atypia 11.Thyroid disorders 12.Breast and genital malignancies 13.Hepatic and renal dysfunction 14.Patient already on antifibrinolytic therapy 15.Patient already on any hormonal therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the PBAC score of patients after treatment with Ormeloxifene and Tranexamic AcidTimepoint: At the time of recruitment to study , 3rd and 6th month after starting treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Effect on blood hemoglobin levels 2.Need for change of therapy while on the intervention 3.To assess for adverse effects of either drugs Timepoint: At the time of recruitment to study , 3rd and 6th month after starting treatment | — |
Countries
India
Contacts
Public ContactPavithra S
Indira Gandhi Medical College and Research Institute
Outcome results
None listed