Status:
UNKNOWN
Study on Combined Use of Letrozole, Mifepristone and Misoprostol in Termination of Pregnancy
Lead Sponsor:
The University of Hong Kong
Conditions:
Complete Abortion
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
By using the combination of mifepristone (anti-progestin), misoprostol (progstanglandin which stimulates uterine contraction), and letrozole (aromatise inhibitor which reduces estrogen production), th...
Detailed Description
After mifepristone was approved by the United States Food and Drug Administration in 2000, the combination of mifepristone 200 mg and vaginal use of misoprostol 800 mcg became almost a standard of car...
Eligibility Criteria
Inclusion
- good general health
- older than the age of legal consent (i.e. \>18 years old)
- requesting medical abortion and eligible for abortion
- on Day 1 of the study (day of letrozole and mifepristone administration) the duration of pregnancy not more than 63 days as confirmed by pelvic ultrasound examination
- intrauterine pregnancy (intrauterine amniotic sac seen in US)
- willing to use other than hormonal or intra-uterine contraception until the first menses after termination of pregnancy
- if treatment should fail agrees to termination of pregnancy with the surgical method
- willing and able to participate after the study has been explained
- haemoglobin higher than 10g/L, normal liver and renal function
Exclusion
- a history or evidence of adrenal pathology, steroid-dependent cancer, porphyria, diastolic pressure over 95mm Hg, bronchial asthma, arterial hypotension
- a history or evidence of thrombo-embolism, severe or recurrent liver disease or pruritus of pregnancy
- the regular use of prescription drugs before admission to the study
- the presence of an IUCD in utero
- breast-feeding
- multiple pregnancies
- heavy smoker of more than 20 cigarettes per day
- any abnormal values in pre-treatment blood tests
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01475318
Start Date
October 1 2011
End Date
June 1 2012
Last Update
November 21 2011
Active Locations (1)
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1
Joyce Chai
Hong Kong, Hong Kong