Health Condition 1: null- Patients presenting with menorrhagia due to uterine myomas
Conditions
Interventions
Intervention1: Ormeloxifene: Ormeloxifene is a Selective Estrogen receptor modulator, which was given in the dose of 60 mg twice weekly for 6 months
Control Intervention1: Novelon: Oral contraceptive
Sponsors
All India institute of medical Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Patients presenting with menorrhagia due to uterine myomas with intramural or subserosal myomas on ultrasound or submucosal grade 2 myomas on hysteroscopy
Exclusion criteria
Exclusion criteria: Patients with more than 16 weeks gravid size uterus, submucosal myomas of grade 0 or 1 on hysteroscopy, atypia on endometrial histopathology, concurrent ovarian pathology, history or currently suffering from thromboembolic disease, smokers more than 35 years age, hypertension or with history of taking hormonal treatment within 3 months of treatment initiation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PBAC Score to assess menstrual blood lossTimepoint: End of 1st, 3rd and 6th month during treatment and at 3 months after stopping treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Bleeding days, cycle length, VAS score for dysmenorrhoea, Myoma volume, side effect, haemoglobinTimepoint: End of 1st, 3rd and 6th month during treatment and at 3 months after stopping treatment, hemoglobin after 6 months of treatment | — |
Countries
India
Contacts
Public ContactAlka Kriplani
All india institute of Medical Sciences, New Delhi
Outcome results
None listed