Study on Combined Use of Letrozole, Mifepristone and Misoprostol in Termination of Pregnancy (NCT01475318) | Clinical Trial Compass
UnknownNot Applicable
Study on Combined Use of Letrozole, Mifepristone and Misoprostol in Termination of Pregnancy
Hong Kong50 participantsStarted 2011-10
Plain-language summary
By using the combination of mifepristone (anti-progestin), misoprostol (progstanglandin which stimulates uterine contraction), and letrozole (aromatise inhibitor which reduces estrogen production), the abortion process will be more effective.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Complete abortion rate
Timeframe: from drug administration till return of next menses (average 4-6 weeks)