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Clinical Trials/ACTRN12617001118392
ACTRN12617001118392RecruitingPhase 2

Safety and efficacy of oral vinorelbine in treatment of ectopic pregnancies

orth Shore Hospital0 sites20 target enrollmentStarted: July 31, 2017Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
20
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Non-randomised trial
Primary Purpose
Treatment
Masking
Open (masking not used)

Eligibility Criteria

Ages
18 Years to 50 Years (—)
Sex
Female

Inclusion Criteria

  • •Aged 18-50 years old
  • •English speaking
  • •Able to provide informed consent to participate
  • •A diagnosis of a tubal ectopic pregnancy on transvaginal ultrasound
  • •A stable ectopic pregnancy (no evidence of bleeding or rupture)
  • •A pre-treatment serum Human Chorionic Gonadotrophin (hCG) level of 1,000 – 3,000 IU/L
  • •Adnexal mass less than or equal to 3.0 cm, with no fetal cardiac activity

Exclusion Criteria

  • •Unable to provide informed consent to participate
  • •A multiple pregnancy
  • •Contraindication(s) to vinorelbine or to medical management of ectopic pregnancy
  • •Immunodeficiency disorder(s)
  • •A current malignancy
  • •Received chemotherapy or radiation therapy in the previous five years
  • •Concomitant disease which could significantly impair gastric absorption (Inflammatory bowel disease, coeliac, etc.)
  • •History of surgical resection of the stomach/small bowel
  • •Breastfeeding
  • •Hepatic impairment, renal impairment, or haematological toxicity

Investigators

Sponsor
orth Shore Hospital

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