Health Condition 1: N925- Other specified irregular menstruation
Conditions
Interventions
Intervention1: Tablet CENTCHROMAN: Tab Centchroman to be started as 60 mg twice weekly for the first 3 months followed by 60 mg once weekly for the next 3 months, follow up visits done at 2 months, 4
Sponsors
ANGANA DAS
Eligibility
Inclusion criteria
Inclusion criteria: 1.Women with heavy menstrual bleeding with or without associated dysmenorrhea or chronic pelvic pain 2.All women with histologically proven endometrial hyperplasia without atypia or any other benign endometrial pathology 3.Fibroid uterus less than 12 weeks in size not distorting the endometrial cavity 4.Adenomyosis 5.All women with medical or surgical high risk factors making the subjects unsuitable for surgery
Exclusion criteria
Exclusion criteria: 1.Active genital infection 2.Suspicion of pregnancy or malignancy 3.Submucosal fibroid distorting the endometrial cavity 4.Uterine fibroids more than 5 centimeters in size 5.Atypical endometrial hyperplasia or malignancy 6.Abnormal cervical cytology and malignancy 7.Haematological disease or abnormal coagulopathy 8.History of arterial or venous thromboembolic disorders 9.Women who want to conceive 10.Women who are not willing to give consent for the study 11.Patients with polycystic ovarian disease or history of jaundice or hepatic impairment or severe allergy or tuberculosis or renal impairment or undiagnosed vaginal bleeding or breast cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy in terms of reduction of menstrual blood loss by PBAC(pictorial blood loss assessment) score calculation before and after treatment with Centchroman and Norethisterone. Timepoint: PBAC score calculation before starting the treatment, at 2 monthly visit, at 4 monthly visit, at 6 monthly visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| To check the mean Hemoglobin levels of the patients before and after treatment with Centchroman and NorethisteroneTimepoint: Hemoglobin level estimation before starting the treatment, at 2 monthly visit, at 4 monthly visit, at 6 monthly visit.;To compare the effect of Centchroman and Norethisterone on the metabolic parameters of the patient (Blood glucose levels, Liver function tests, Serum lipid profile)Timepoint: Fasting blood glucose, post-prandial blood glucose, lipid profile, liver function test and glycosylated hemoglobin (HbA1C) level estimation before starting the treatment, at 2 monthly visit , at 4 monthly visit, at 6 monthly visit;To compare the endometrial thickness on Ultrasonography before and after treatment with Centchroman and NorethisteroneTimepoint: Endometrial thickness (ET) measurement on USG before starting the treatment, at 2 monthly visit, at 4 monthly visit, at 6 monthly visit. | — |
Countries
India
Contacts
Public ContactDR MANISHA BAJAJ
ESI PGIMSR ESICMCH JOKA KOLKATA
Outcome results
None listed