Health Condition 1: null- myoma
Conditions
Interventions
Intervention1: Ulipristal Acetate: Ulipristal Acetate 5mg tablet will be given daily for 13 weeks
Control Intervention1: Leuprolide acetate(GnRH agonists): Leuprolide Acetate injection 3.75 mg will be
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age group: 21 to 49 years of age. 2.Uterus size 3.Ultrasonography suggestive of at least one uterine myoma of >= 3 cm diameter in size. 4.Provide informed written consent.
Exclusion criteria
Exclusion criteria: 1.Uterine size > 18 weeks on clinical examination. 2.Any single myoma size > 10 cm on ultrasonography. 3.Treatment with any hormonal preparation within 3 months of recruitment. 4.History of myomectomy. 5.History of uterine artery embolization. 6.Known case of uncontrolled thyroid disorders, liver disease, hemoglobinopathy coagulation disorder. 7.Large uterine polyp ( >2 cm), Submucosal fibroid (class 0 under myoma sub classification system). 8.Ovarian cysts >=4 cm in diameter as measured by ultrasound. 9.Suspected or known case of gynecological cancer/atypical endometrial hyperplasia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (a) Fibroid volume as assessed by USG (b) Pictorial blood loss assessment chart (PBAC) Score.Timepoint: Baseline, 3month, 6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| (a) Pain measured with the use of Visual analogue scale (VAS) scoreTimepoint: Baseline, 3month, 6 month;(b) Pulsatility index, Resistivity index of uterine Arteries.Timepoint: Baseline, 3month, 6 month | — |
Countries
India
Contacts
Public ContactDr Ram Kumar Patidar
All India Institute of Medical Sciences
Outcome results
None listed