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II for Birth Control
Phase 4
Waitlist Available
Led By Wendy V Norman, MD, FCFP
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial will help to improve information about the most effective contraception for women who have had an abortion, in order to reduce the number of unintended pregnancies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The expulsion rate of each IUD
Secondary outcome measures
Voluntary discontinuation rate of contraception
Trial Design
3Treatment groups
Active Control
Group I: IIIActive Control1 Intervention
Participants who elect for forms of contraception other than a copper IUD will chose which form of contraception they would like to use and be put into one of the groups specified below based on her contraceptive choice. These participants will be observed throughout the study for overall satisfaction and repeat pregnancy rate.
Groups - Participants will be in one of the five following groups Group A - Oral contraceptive pill 28day supply provided after abortion Group B - Medroxyprogesterone acetate (Depo-provera)150mg IM provided after abortion, lasts for 3 months Group C - Ethinyl estradiol and etonogestrel (Nuva ring) provided at time of abortion, lasts for 28 days Group D - Condoms provided at time of abortion Group E - Other
Group II: IIActive Control1 Intervention
Participants who elect to have an IUD inserted at the time of abortion will be randomized to either Arm I or Arm II. In this arm participants will receive the Nova T IUD. The participant is counseled that she may leave the device in for up to five years. She will be followed for up to five years to determine expulsion rate, discontinuation rate, pregnancy rate, and overall satisfaction with form of contraception.
Group III: IActive Control1 Intervention
Participants who elect to have an IUD inserted at the time of abortion will be randomized to either Arm I or Arm II. In this arm participants will receive the Flexi T 380(+) IUD. The participant is counseled that she may leave the device in for up to five years. She will be followed for up to five years to determine expulsion rate, discontinuation rate, pregnancy rate, and overall satisfaction with form of contraception.
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,410 Previous Clinical Trials
1,766,037 Total Patients Enrolled
Society of Family PlanningOTHER
98 Previous Clinical Trials
16,600 Total Patients Enrolled
Wendy V Norman, MD, FCFPPrincipal InvestigatorUniversity of British Columbia
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent could I pose a risk to those who take it?
"Assessing the safety of this intervention, our team has attributed a score of 3 based on its Phase 4 classification and current approval status."
Answered by AI
Are there any spots available for volunteers to participate in this investigation?
"This investigation, which was first posted on September 1st 2010 and most recently edited on May 19th 2022 is not currently seeking additional participants. Nevertheless, 61 other trials are open for enrollment of volunteers."
Answered by AI
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