Abortion incidence between 1990 and 2014: global, regional, and subregional levels and trends.
Gilda Sedgh, Jonathan Bearak, Susheela Singh...
https://pubmed.ncbi.nlm.nih.gov/27179755Actively Recruiting
Phase 4
Age: 21Years +
FEMALE
ID05341817
The Use of Letrozole or Mifepristone for Pretreatment of Medical Termination of Pregnancy A Randomized Trial Comparing Two Drug Regimens for Early Pregnancy Termination
Led by KK Women's and Children's Hospital · Updated on 2025-01-22
144
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of letrozole compared to mifepristone as pre-treatment options for medical termination of pregnancy (mTOP) up to 10 weeks gestation. The study focuses on women seeking abortion in the first trimester and aims to determine whether letrozole, a potentially cheaper and more accessible drug, is as effective as the current standard treatment with mifepristone. This study is a randomized, non-inferiority trial designed to provide preliminary data supporting the use of letrozole in mTOP. Participants are randomly assigned to one of two groups: the intervention group receives 10 mg of oral letrozole daily for three days followed by 800 mcg of vaginal misoprostol on day three. The control group receives a single 200 mg oral dose of mifepristone on day one, followed by 800 mcg of vaginal misoprostol two days later, with an additional 400 mcg dose of misoprostol given four hours later if no abortion signs are observed. The study includes a total of 144 patients, with 72 in each group. During the study, participants will be monitored for the rate of complete abortion by day 21 to 28 after treatment. Researchers will assess outcomes such as time to abortion, number of misoprostol doses needed, healthcare resource use, and side effects. The goal is to provide evidence that may lead to a more cost-effective and widely available mTOP treatment option, potentially reducing reliance on surgical methods and improving care for women undergoing abortion.
CONDITIONS
Official Title
The Use of Letrozole or Mifepristone for Pretreatment of Medical Termination of Pregnancy
Who Can Participate
Age: 21Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- 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 4 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
You will not qualify if you...
- 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
AI-Screening
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1
2
3
Trial Site Locations
Total: 1 location
1
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Actively Recruiting
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Research Team
M
Meei Jiun Seet
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Medical termination for pregnancy in early first trimester (≤ 63 days) using combination of mifepristone and misoprostol or misoprostol alone: a systematic review.
Ferid A Abubeker, Antonella Lavelanet, Maria I Rodriguez...
https://pubmed.ncbi.nlm.nih.gov/32635921The true cost differential between mifepristone and misoprostol and misoprostol-alone regimens for medical abortion.
Mitchell D Creinin, Eliane Shore, Shyamala Balasubramanian...
https://pubmed.ncbi.nlm.nih.gov/15639068Synergistic effects of antiprogestins and iNOS or aromatase inhibitors on establishment and maintenance of pregnancy.
Leili Shi, Shao-Qing Shi, Randall L Given...
https://pubmed.ncbi.nlm.nih.gov/14668001The effect of letrozole with misoprostol for medical termination of pregnancy on the expression of steroid receptors in the placenta.
Vivian Chi-Yan Lee, Jing Gao, Kai-Fai Lee...
https://pubmed.ncbi.nlm.nih.gov/23980056Effect of letrozole on uterine artery Doppler flow indices prior to first-trimester termination of pregnancy: a randomized controlled trial.
V C Y Lee, T W Y Yeung, O S Tang...
https://pubmed.ncbi.nlm.nih.gov/22302719The effect of 7 days of letrozole pretreatment combined with misoprostol on the expression of progesterone receptor and apoptotic factors of placental and decidual tissues from first-trimester abortion: a randomized controlled trial.
Sofie Shuk Fei Yung, Vivian Chi Yan Lee, Philip Chi Ngong Chiu...
https://pubmed.ncbi.nlm.nih.gov/26707996Misoprostol with or without letrozole pretreatment for termination of pregnancy: a randomized controlled trial.
Vivian Chi Yan Lee, Ernest Hung Yu Ng, William Shu Biu Yeung...
https://pubmed.ncbi.nlm.nih.gov/21252745Letrozole pretreatment prior to medical termination of pregnancy: a systematic review.
Christopher M Nash, Lauren Philp, Prakesh Shah...
https://pubmed.ncbi.nlm.nih.gov/29154779