Comparing Two Regimens for Medical Abortion: Mifepristone+Misoprostol Versus Misoprostol Alone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00680394
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : March 13, 2013
Information provided by (Responsible Party):
Gynuity Health Projects

Brief 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.

Condition or disease Intervention/treatment Phase
Pregnancy Termination Drug: mifepristone Drug: misoprostol Drug: placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparing Two Regimens for Medical Abortion: Mifepristone+Misoprostol Versus Misoprostol Alone
Study Start Date : July 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: mifepristone+misoprostol
200 mg mifepristone+ 800 mcg buccal misoprostol
Drug: mifepristone
200 mg mifepristone

Drug: misoprostol
800 buccal misoprostol + matching placebo or 1600 buccal misoprostol

Experimental: misoprostol
800 mcg buccal misoprostol+placebo
Drug: misoprostol
800 buccal misoprostol + matching placebo or 1600 buccal misoprostol

Drug: placebo
800 buccal misoprostol + matching placebo or 1600 buccal misoprostol

Primary Outcome Measures :
  1. Efficacy defined as complete abortion without recourse to surgical abortion. [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00680394

La Rabta Hospital
Tunis, Tunisia
Hung Vuong Hospital
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Gynuity Health Projects
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gynuity Health Projects Identifier: NCT00680394     History of Changes
Other Study ID Numbers: Protocol 1.2.1
First Posted: May 20, 2008    Key Record Dates
Last Update Posted: March 13, 2013
Last Verified: March 2013

Keywords provided by Gynuity Health Projects:
medical abortion

Additional relevant MeSH terms:
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Abortifacient Agents, Steroidal
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents