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Outpatient Medical Abortion With Mifepristone and Misoprostol Through 77 Days of Gestation (XXGA)

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ClinicalTrials.gov Identifier: NCT02314754
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : July 14, 2016
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Brief Summary:
To demonstrate non-inferiority of the efficacy of 200 mg mifepristone followed in 24 to 48 hours by 800 µg buccal misoprostol in outpatient medical abortion services among women 71-77 days' compared to women 64-70 days' LMP.

Condition or disease Intervention/treatment Phase
Medical Abortion Drug: Mifepristone followed by misoprostol 24-48 hours later Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 719 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outpatient Medical Abortion With Mifepristone and Misoprostol Through 77 Days of Gestation: A Non-inferiority Trial
Study Start Date : December 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 71-77 days gestational age
Women whose pregnancies are estimated to have a gestational age of 71-77 days.
Drug: Mifepristone followed by misoprostol 24-48 hours later
200mg oral mifepristone and 800mcg buccal misoprostol 24-48 hours after mifepristone

No Intervention: 64-70 days gestational age
Women whose pregnancies are estimated to have a gestational age of 64-70 days.( Women in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range).



Primary Outcome Measures :
  1. Efficacy as determined by the proportion of successful terminations without surgical intervention (suction curettage or D&C) for any reason [ Time Frame: 7-36 days ]
    Efficacy of medical abortion in the later first trimester as determined by the proportion of successful terminations without surgical intervention (suction curettage or D&C) for any reason


Secondary Outcome Measures :
  1. Proportion of Individual Side Effects Experienced by Participants [ Time Frame: 7-14 days ]
    Side effects include diarrhea, nausea, vomiting, fever, chills, headaches, dizziness and/or weakness experienced by participants

  2. Proportion of Women Who Determine Method Acceptable [ Time Frame: 7-14 days ]
    overall acceptability, time to complete abortion, bleeding, side effects, pain

  3. Proportion of Providers Who Determine Method Acceptable [ Time Frame: 7-36 days ]
    As assessed by service provider semi-structured interviews



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • intrauterine pregnancy between 64 days and 77 days' LMP
  • eligible for medical abortion according to study doctor assessment
  • willing and able to sign consent form
  • speak english or spanish (in US sites); speak the local language(s) (in international sites)
  • agree to comply with the study procedures and visit schedule

Exclusion Criteria:

  • Have known allergies or present other contraindications to mifepristone or misoprostol

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 ClinicalTrials.gov identifier (NCT number): NCT02314754


Locations
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United States, Connecticut
Hartford GYN Center
Hartford, Connecticut, United States, 06106
United States, Georgia
Atlanta Women's Center
Atlanta, Georgia, United States, 30342
United States, Illinois
John H. Stroger, Jr. Hospital of Cook CountY
Chicago, Illinois, United States, 60612
Family Planning Associates Medical Group
Chicago, Illinois, United States, 60630
Azerbaijan
Scientific Research Institute of Obstetrics and Gynecology
Baku, Azerbaijan
Georgia
David Gagua Clinic
Tbilisi, Georgia
Mexico
Clínica Comunitaria Santa Catarina
Mexico City, Mexico
Vietnam
Hung Vuong Hospital
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Gynuity Health Projects
Investigators
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Principal Investigator: Beverly Winikoff, MD,MPH Gynuity Health Projects

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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02314754     History of Changes
Other Study ID Numbers: 1016
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
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Misoprostol
Mifepristone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
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