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Progestin Only Contraceptive Pills for Birth Control
Phase 4
Waitlist Available
Led By Sarah Averbach, MD, MAS
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Speak English or Spanish
Had a vaginal or cesarean delivery of a singleton full term (≥37 weeks) infant less than 168 hours prior Intends to breastfeed exclusively for 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 and 8 weeks postpartum
Awards & highlights
Study Summary
This trial will compare the effects of two types of birth control pills on mothers, their breastmilk, and their infants.
Eligible Conditions
- Birth Control
- Breastfeeding
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 and 8 weeks postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 and 8 weeks postpartum
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants exclusively breastfeeding at 2 months postpartum
Secondary outcome measures
Breastfeeding supplementation type
Carbohydrate content of breastmilk
Change in infant head circumference
+8 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Early Initiation n-POPsExperimental Treatment1 Intervention
Initiation of n-POPs 120-160 hours after delivery. Dosing is 0.35mg daily for 28 days for 2 months.
Group II: Early Initiation d-POPsExperimental Treatment1 Intervention
Initiation of d-POPs 120-160 hours after delivery. Dosing is 4mg daily for 24 days followed by 4 daily inactive tablets for 2 months.
Group III: Interval Initiation of d-POPsPlacebo Group1 Intervention
Placebo starting 120-160 hours after delivery, continuing for 28 days. Followed by 24 days of 4mg daily of d-POPs and 4 daily inactive tablets.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Norethisterone
FDA approved
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,115 Previous Clinical Trials
1,519,851 Total Patients Enrolled
Sarah Averbach, MD, MASPrincipal InvestigatorUniversity of California, San Diego
2 Previous Clinical Trials
690 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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