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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02985229
Other study ID # 1028
Secondary ID
Status Completed
Phase Phase 3
First received October 19, 2016
Last updated April 4, 2018
Start date October 2016
Est. completion date July 2017

Study information

Verified date April 2018
Source Gynuity Health Projects
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To test the hypothesis that a regimen of 200 mg oral mifepristone, with the option of home administration, followed by 800 μg buccal misoprostol 24 hours later for abortion through 70 days LMP will be feasible and acceptable in Singapore.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Have an intrauterine pregnancy consistent wit gestational age = 70 days

- Be 21 years of age or over

- Be willing and able to sign consent forms

- Be eligible for abortion according to current hospital guidelines

- Be able to return to the clinic and able to contact study staff or emergency medical services if needed

- Be willing to provide an address, email and/or telephone number for purposes of follow-up

- Agree to comply with the study procedures and visit schedule

Exclusion Criteria:

- confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass

- chronic renal failure

- concurrent long-term corticosteroid therapy

- history of inherited porphyrias

- IUD in place (must be removed after mifepristone is administered).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Mifepristone
The option of home or clinic administration of 200 mg oral mifepristone
Misoprostol
800 µg buccal misoprostol through 70 days LMP following administration of mifepristone

Locations

Country Name City State
Singapore KK Women's and Children's Hospital Singapore
Singapore National University Hospital Singapore

Sponsors (1)

Lead Sponsor Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of successful abortion Proportion of abortions that are complete without surgical intervention 7-10 days after mifepristone administration
Secondary Satisfaction with the medical abortion method Proportion of women who are satisfied with the medical abortion method 7-10 days after mifepristone administration
Secondary Preferred location of mifepristone administration Proportion of women who select home use of mifepristone The day of enrollment
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