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Completed

NCT Number: NCT02314754

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

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.

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Key information

Conditions

Medical Abortion

Age range

11 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Scientific Research Institute of Obstetrics and Gynecology, Baku, Azerbaijan

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mifepristone followed by misoprostol 24-48 hours later

Drug

200mg oral mifepristone and 800mcg buccal misoprostol 24-48 hours after mifepristone

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Official study title

Outpatient Medical Abortion With Mifepristone and Misoprostol Through 77 Days of Gestation: A Non-inferiority Trial

Acronym: XXGA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 11, 2014
Registry last updated
Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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