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The Use of Letrozole or Mifepristone for Pretreatment of Medical Termination of Pregnancy

RecruitingPhase 4Ages 21 Years - anyFemaleKK Women's and Children's Hospital
NCT05341817 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Medical termination of pregnancy (mTOP) generally involves using either a combined regimen consisting of mifepristone and misoprostol, or a misoprostol-only regimen. Complete abortion rates of first trimester mTOP with the use of misoprostol-only regimen varies between 74-88%. With the addition of mifepristone as pre-treatment drug, this improves success rates to 93-97%. Mifepristone, an anti-progesterone, is relatively expensive and is subject to stringent regulations for usage in addition to restricted access in many countries. Therefore, there is a need to find a cheaper and more readily available, yet effective alternative. The use of letrozole (an aromatase inhibitor) in mTOP is postulated to suppress estradiol levels (an important factor in the maintenance of early pregnancy), therefore enhancing the effect of misoprostol in inducing abortion. Studies have shown that pre-treatment

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📋 Eligibility rules (as published)
Inclusion Criteria: * 21 years and above * Patient requesting for medical termination of pregnancy (mTOP) * Patient eligible for legal abortion according to the Termination of Pregnancy Act (Chapter 324) * Gestational age ≤10 weeks (on day 1 of mifepristone or letrozole administration) as confirmed by the first trimester dating scan * Singleton pregnancy * Patient is agreeable to undergo surgical evacuation or repeat medical therapy if treatment fails * Willing and able to provide written, informed consent Exclusion Criteria: * History or evidence of adrenal pathology, steroid-dependent cancer, porphyria, poorly controlled hypertension, bronchial asthma, thromboembolism and severe cardiac/renal/liver disease * Haemoglobin level of \<9.5 g/L * Presence of an intrauterine contraceptive device * Breastfeeding * Reported allergic reaction to mifepristone, misoprostol or letrozole, * Participating in another trial of investigational medicinal products during the current pregnancy
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What it tests

  • Letrozole
  • Mifepristone
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Where

1 site
KK Women&#39;s and Children&#39;s Hospital
Singapore, Singapore
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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