None listed
Conditions
Interventions
Intervention1: Tablet Mifepristone: Participants will receive Mifepristone tablets 10/25 mg for 20 days and then uterus and blood samples will be collected from subjects undergoing hysterectomy, then
Sponsors
Womed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Planned hysterectomy for one or more symptomatic fibroids 2. Age 18 to 50 years 3. Is willing to participate in study and consented for the same 4. Is willing to take daily oral treatment of 10 mg or 25 mg mifepristone during 20 days before hysterectomy 5. Is willing to give blood sample before starting Mifepristone and after completing 20 doses
Exclusion criteria
Exclusion criteria: Medical History 1. Post menopausal 2. Any contraindication to hysterectomy 3. Uterus larger than a sixteen weeks gestation uterus as measured by pelvic manual examination 4. Abnormal liver and renal function 5. History of relevant known or suspected malignant tumors. 6. History of unexplained vaginal bleeding or endometrial hyperplasia with atypia or endometrial carcinoma 7. Contraindication to mifepristone, including: adrenal disease; sickle cell anemia; severe liver, respiratory, or renal disease; and blood clotting defect. 8. History of allergy to Mifepristone Prior or concomitant medication 9. CYP3A inhibitors (itraconazole, voriconazole, clarithromycin, erythromycin) or inducers (barbiturates, carbamazepine, nevirapine, phenytoin, primidone, rifabutin, rifampicin, ritonavir, herbals containing hypericum perforatum) as well as consumption of grapefruit and derivatives (juices etc?). 10. Participation in clinical studies of drugs in the past 3 months Other 11. Inability to establish a venous catheter for blood sampling. 12. Regular consumption of more than 10 g of alcohol per day or anamnestic information about alcoholism, drug addiction, drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary research objective of the current study is to obtain uterine tissue concentrations after 20 days of daily oral treatment with mifepristone at 10 and 25 mg/day.Timepoint: Mifepristone tissue concentrations at trough levels after 20 days of daily treatment in endometrium, myometrium and fibroid tissue | — |
Secondary
| Measure | Time frame |
|---|---|
| A secondary objective is to obtain the corresponding systemic concentrationsTimepoint: Plasma concentrations of mifepristone at trough levels after 20 days of daily treatment | — |
Countries
India
Contacts
Public ContactDr Sharad Singh
Womed
Outcome results
None listed