EUCTR2011-001820-39-NLActive, not recruitingPhase 1
evothyroxine for euthyroid women with recurrent miscarriage and thyroid autoimmunity : a randomized controlled trial - T4Life
Academic medical centre0 sites240 target enrollmentStarted: December 14, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 240
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •1.Women with unexplained RM and thyroid autoimmunity. Recurrent miscarriage is defined as two or more miscarriages. TPOAb positivity is defined as a TPO titre higher then 100 kU/ltr or two times higher then 60 kU/ltr.
- •2.Age 18 - 42 years at randomisation
- •3.Willing and able to give informed consent (IC).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 240
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1.Antiphospholipid syndrome (lupus anticoagulant and/ or anticardiolipin antibodies [IgG or IgM])
- •2. Other auto-immune conditions
- •3.Previous enrolment in the trial
- •4. Abnormal TSH levels
- •5. Contraindications to levothyroxine use:
- •Adrenal or pituitary disorders, untreated
- •Thyreotoxicosis, untreated
- •Acute cardiac arrest
- •Acute pancreatitis
- •Acute myocarditis
Investigators
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