Study on Combined Use of Letrozole, Mifepristone and Misoprostol in Termination of Pregnancy

• Status: Unknown status
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Letrozole; Mifepristone; Misoprostol

Criteria

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