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Clinical Trials/CTRI/2018/06/014616
CTRI/2018/06/014616
Completed
Phase 4

Comparison of efficacy and safety of different dosages of mifepristone in women with symptomatic fibroids.

Department of obstetrics and gynaecology0 sites92 target enrollmentTBD
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Department of obstetrics and gynaecology
Enrollment
92
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
July 10, 2019
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Department of obstetrics and gynaecology

Eligibility Criteria

Inclusion Criteria

  • •1\.Symptomatic fibroid cases, measuring at least 3 cm exhibiting heavy menstrual bleeding or dysmenorrhoea or pelvic pressure 2\.Those giving consent
  • •3\.Accepting the use of non\-hormonal contraceptive
  • •4\.Agreeing to endometrial biopsy if needed

Exclusion Criteria

  • •1\.currently planning pregnancy during study period
  • •2\.menopausal
  • •3\.currently breastfeeding
  • •4\.adnexal mass or endometriosis
  • •5\. coagulation dysfunction or bleeding tendencies
  • •6\.severe anemia \<5 g% or needing blood transfusion
  • •7\.current or recent (within 3 months) use of oral / systemic corticosteroids or mifepristone
  • •8\.use within past 6 months of GnRH analogues
  • •9\.any contraindication to receive anti\-progestins
  • •10\.any history or suspicion of breast cancer or other genital malignancy

Outcomes

Primary Outcomes

Not specified

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