Health Condition 1: N921- Excessive and frequent menstruation with irregular cycle
Conditions
Interventions
Intervention1: Ormeloxifene 60 mg twice a week for 3 months in test group .: 1.LNG-IUS insertion along with tab ormeloxifene 60 mg twice a week for 3 months will be started from date of insertion in
Sponsors
Dr Sushma
Eligibility
Inclusion criteria
Inclusion criteria: Patient with abnormal uterine bleeding 1. Age group: 21 – 50 yrs 2. Endometrial biopsy showing benign pathology 3. No distortion of endometrial cavity on USG 4. Uterine size 5. Willing to provide informed written consent.
Exclusion criteria
Exclusion criteria: 1. Endometrial hyperplasia with atypia / Endometrial cancer 2. History of any malignancy 3. Current signs of PID 4. Endocrinopathy or other systemic disorder causing heavy menstrual bleeding 5. Current signs of PID 6. Abnormal Pap smear finding 7. Pregnancy, decision of pregnancy 8. Postmenopausal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of days with bleeding and spottingTimepoint: 1 YEAR | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Side effects of LNG-IUS insertion 2. PBAC score in both the groups 3. Rate of discontinuation of LNG-IUS due to side effects 4. Satisfaction level of patients 5. Side effects of ormeloxifen (ovarian cyst, cervical erosion & discharge, gastric dyspepsia, vague abdominal pain, headache & others). 6. Haemoglobin level Timepoint: 1 YR | — |
Countries
India
Contacts
Public ContactDr Richa Vatsa
AIIMS , New Delhi
Outcome results
None listed