A trial designed to treat women with a diagnosis of ectopic pregnancy with a combination of methotrexate (standard treatment) and gefitinib (trial agent)

Phase 3

Completed

• Conditions: Ectopic Pregnancy; Ectopic pregnancy; Pregnancy and Childbirth

• Registration Number: ISRCTN67795930
• Lead Sponsor: niversity of Edinburgh and NHS Lothian ACCORD

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30458863 protocol 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36738759/ (added 06/02/2023) 2023 Results article in https://doi.org/10.1093/humrep/dead089 Secondary analysis (added 15/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-15
• Study Completion: 2022-03-01
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 328

Inclusion Criteria

1. Clinical decision made for treatment of tubal EP with MTX
2. Able to understand all information (written and oral) presented (using an interpreter if necessary) and provide signed consent
3. Women 18-50 years at time of randomisation
4. Diagnosis of either:
4.1. Definite tubal EP (extrauterine gestational sac with yolk sac and/or embryo, without cardiac activity on USS) or
4.2. Clinical decision of probable tubal EP (extrauterine sac-like structure or inhomogeneous adnexal mass on USS with a background of sub optimally rising serum hCG concentrations (on at least 2 different days)
5. Pre-treatment serum hCG level of 1000–5000 iu/L (within 1 calendar day of treatment)
6. Clinically stable
7. Haemoglobin between 100 and 165 g/L within 3 calendar days of treatment
8. Able to comply with treatment and willing to participate in follow up

Exclusion Criteria

1. Women with a Ppregnancy of unknown location (PUL)
2. Evidence of intrauterine pregnancy
3. Breastfeeding
4. Hypersensitivity to gefitinib
5. Women with mean EP mass on ultrasound greater than 3.5cm (mean dimensions)
6. Women with evidence of intrauterine pregnancy
7. Evidence of significant intra-abdominal bleed on ultrasound USS defined by echogenic free fluid above the uterine fundus or surrounding ovary within 1 calendar day of treatment
8. Significant abdominal pain, guarding/rigidity
9. Clinically significant abnormal liver/renal/haematological indices noted within 3 calendar days of treatment
10. Galactose intolerance
11. Significant pre-existing dermatological disease eg severe psoriasis/eczema
12. Significant pulmonary disease eg severe/uncontrolled asthma
13. Significant gastrointestinal medical illness eg Crohn’s disease/ulcerative colitis
14. Participating in any other clinical trial of an investigational medicinal product
15. Previous participation in GEM3
16. Women of Japanese ethnicity

Study & Design

• Study Type: Interventional
• Study Design: Not specified