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Progestin-only pill

Drospirenone-only pill for Emergency Contraception

Phase 2
Waitlist Available
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured daily for the seven days immediately following administration of the drospirenone-only pill dose during the intervention cycle (cycle length 21-35 days)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if a single dose of drospirenone can prevent ovulation in women who are overweight or obese. Current emergency contraceptives don't work as well for these women, so this study aims to find a better option. Drospirenone is a new type of hormone that has been shown to stop ovulation and is used in various contraceptive methods.

Eligible Conditions
  • Birth Control

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured daily for the seven days immediately following administration of the drospirenone-only pill dose during the intervention cycle (cycle length 21-35 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured daily for the seven days immediately following administration of the drospirenone-only pill dose during the intervention cycle (cycle length 21-35 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dominant ovarian follicle ultrasound measurement
Serum progesterone concentration
Secondary study objectives
Serum potassium concentration

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Primary ovulation inhibition testingExperimental Treatment1 Intervention
Drospirenone-only pill single-dose at dose determined by dose finding arm
Group II: Dose findingExperimental Treatment1 Intervention
Drospirenone-only pill single-dose ranging from 16mg to 32mg

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,806 Previous Clinical Trials
2,822,321 Total Patients Enrolled

Media Library

Drospirenone-only pill (Progestin-only pill) Clinical Trial Eligibility Overview. Trial Name: NCT05675644 — Phase 2
Birth Control Research Study Groups: Dose finding, Primary ovulation inhibition testing
Birth Control Clinical Trial 2023: Drospirenone-only pill Highlights & Side Effects. Trial Name: NCT05675644 — Phase 2
Drospirenone-only pill (Progestin-only pill) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05675644 — Phase 2
~13 spots leftby Nov 2025
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