Comparing Two Regimens for Medical Abortion: Mifepristone+Misoprostol Versus Misoprostol Alone
Information source: Gynuity Health Projects
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pregnancy Termination
Intervention: mifepristone (Drug); misoprostol (Drug); placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Gynuity Health Projects Official(s) and/or principal investigator(s):
Beverly Winikoff, MD, MPH, Principal Investigator, Affiliation: Gynuity Health Projects
Summary
A double blinded, placebo-controlled randomized trial to compare the safety, efficacy and
acceptability of two medical abortion regimens up to 63 days' LMP. The first regimen will
include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol. The
second regimen will include two 800 mcg doses of buccal misoprostol. We hypthesize that both
methods work well, but that the mifepristone regimen will have an efficacy rate of
approximately 95%, and misoprostol alone will be closer to 90%. We will consider a greater
than 5% difference to be clinically meaningful.
Clinical Details
Official title: Comparing Two Regimens for Medical Abortion: Mifepristone+Misoprostol Versus Misoprostol Alone
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Efficacy defined as complete abortion without recourse to surgical abortion.
Detailed description:
Non-surgical abortion methods have the potential to improve the quality and safety of women's
reproductive health in the developing world. However, until recently, widespread
availability and utilization of medical abortion with mifepristone in low resource countries
has been restricted by the limited availability of mifepristone and perceived high cost of
the drug, while the low and varied rates of efficacy of the misoprostol alone regimens have
hindered its widespread adoption. In recent years, a handful of new mifepristone and
misoprostol products have come to the market, easing the availability and reducing the cost
of both drugs, and therefore making their introduction in new settings more feasible.
Nonetheless, mifepristone is much more expensive than misoprostol (approximately $4 - 6 a
tablet versus $0. 35 a tablet) and often a large part of the cost of the medical abortion
cost. In this respect, this study provides an important opportunity to better understand the
real difference in efficacy of the two regimens in addition to the costs and benefits of
these two non-surgical abortion regimens.
The study will contribute greatly to the literature on medical abortion. First, it will be
the first randomized trial to compare two buccal regimens (and the second ever to compare
mifepristone+misoprostol with misoprostol alone. Second, if proven efficacious, it promises
to offer alternative regimens for use in women with gestations up to 63 days' LMP. Third, it
may create evidence in support of shortening the time to abortion completion, by offering all
women in the mifepristone arm the chance to complete their abortions 24 hours after
mifepristone, instead of the standard 48 hours later. Lastly, it provides a unique
opportunity to systematically and in a non-biased manner, compare the side effects and
acceptability of these two regimens, thereby creating more information to help providers and
policy makers debate the relative costs and benefits of these two medical abortion regimens.
A total of 700 women will be recruited. We assume that the efficacy of mifepristone plus
buccal misoprostol is approximately 95%. The efficacy of misoprostol alone for medical
abortion, via the vaginal route, is 88%. The efficacy of misoprostol alone via the buccal
route is not known, nor is the efficacy via the buccal route with repeat dosing after a 24
hour interval. We expect that the efficacy with buccal misoprostol should be similar to that
with vaginal misoprostol based on both pharmokinetic and clinical data.
We assume that the efficacy of mifepristone plus buccal misoprostol in our research settings
will be 95%. A difference in efficacy of buccal misoprostol alone of at least 5% (90%) is
clinically meaningful to providers and women.
Using alpha = 0. 05 with a one-sided test and power = 0. 80, the number needed to demonstrate
this difference is 664 (334 in each arm). Assuming 5% will drop out or not complete the
protocol, we plan to enroll a total of 700 women.
The primary endpoint is efficacy; safety, acceptability and side effects will be assessed as
secondary endpoints.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Gestational age < 63 days by LMP, ultrasound or clinical assessment.
- General good health including absence of conditions which contraindicate the use of
mifepristone and misoprostol for pregnancy termination.
- Agrees to return for follow-up visit and willing to provide an address and/or
telephone number for purposes of follow-up.
- Able to consent to study participation.
Exclusion Criteria:
- Gestational age > 63 days
- Confirmed or suspected ectopic or molar pregnancy
- Contraindications to medical abortion including IUD in place (must be removed before
procedure), chronic adrenal failure, concurrent long-term corticosteroid therapy,
history of allergy to mifepristone, misoprostol or prostaglandin, hemorrhagic
disorders or concurrent anticoagulant therapy, inherited porphyries.
Locations and Contacts
La Rabta Hospital, Tunis, Tunisia
Hung Vuong Hospital, Ho Chi Minh City, Vietnam
Additional Information
Starting date: July 2007
Ending date: May 2008
Last updated: May 19, 2008
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