Using Letrozole or Mifepristone for Medical Termination of Pregnancy
The Use of Letrozole or Mifepristone for Pretreatment of Medical Termination of Pregnancy: a Randomized, Non-inferiority Trial
This study is testing if letrozole can be a more effective and affordable option than mifepristone for women having a medical abortion in the first trimester.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | KK Women's and Children's Hospital Government |
| Locations | 1 site (Singapore) |
| Trial ID | NCT05341817 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of letrozole as a pre-treatment for medical termination of pregnancy (mTOP) compared to the standard mifepristone regimen. The study aims to determine if letrozole can achieve similar or improved complete abortion rates while being a more cost-effective and accessible alternative. Participants will receive either letrozole or mifepristone before the administration of misoprostol, with the goal of enhancing the success rates of abortion in the first trimester. The trial will include women aged 21 and above who are eligible for legal abortion and have a singleton pregnancy of up to 10 weeks gestation.
Who should consider this trial
Good fit: Ideal candidates are women aged 21 and older requesting medical termination of pregnancy within the first trimester.
Not a fit: Patients with certain medical conditions, such as severe cardiac or renal disease, or those who are breastfeeding, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more affordable and accessible option for women seeking medical termination of pregnancy.
How similar studies have performed: Previous studies have shown promising results with letrozole as a pre-treatment for mTOP, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Singapore
- KK Women's and Children's Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Meei Jiun Seet — Consultant at KK Women&#39;s and Children&#39;s Hospital, Singapore
- Study coordinator: Meei Jiun Seet
- Email: julin.wong.sx@kkh.com.sg
- Phone: (+65) 97865163
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.