Study on Combined Use of Letrozole, Mifepristone and Misoprostol in Termination of Pregnancy
A Pilot Study on the Combined Use of Letrozole, Miferpristone and Misoprostol in Termination of First Trimester Pregnancy up to 63 Days Gestation
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 31, 2011
CompletedFirst Posted
Study publicly available on registry
November 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedNovember 21, 2011
November 1, 2011
8 months
October 31, 2011
November 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete abortion rate
If no suction evacuation is required before the return of next menstruation, it is classified as complete abortion
from drug administration till return of next menses (average 4-6 weeks)
Secondary Outcomes (3)
the induction-to-abortion interval
drug administration to passage of abortus (average within 48 hours)
incidence of side effects
drug administration (D1) till D43
the duration of bleeding
drug administration till cessation of bleeding (average 4-6 weeks)
Study Arms (1)
misoprostol + mifepristone + letrozole
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Joyce Chai
Hong Kong, Hong Kong
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2011
First Posted
November 21, 2011
Study Start
October 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
November 21, 2011
Record last verified: 2011-11