Drospirenone-only pill for Emergency Contraception
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires participants to stop taking medications and supplements that are known to affect CYP3A4, an enzyme involved in drug metabolism, during the study period. If you are currently taking any of these, you will need to stop.
Is the drospirenone-only pill safe for use as emergency contraception?
Drospirenone, used in various contraceptive formulations, has been shown to have a good safety profile with low cardiovascular risks and no increased risk of hyperkalemia (high potassium levels) or thromboembolic events (blood clots) compared to other contraceptives. It is generally well-tolerated, with benefits such as improved mood and reduced weight gain.12345
How does the drospirenone-only pill differ from other emergency contraception drugs?
The drospirenone-only pill is unique because it uses drospirenone, a synthetic hormone similar to progesterone, which has antimineralocorticoid and antiandrogenic properties. This is different from other emergency contraceptives that typically use levonorgestrel or ulipristal acetate, focusing on different hormonal pathways.24678
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Finding
Participants receive a single dose of drospirenone ranging from 16mg to 32mg to evaluate ovulation inhibition
Primary Ovulation Inhibition Testing
Participants receive a single dose of drospirenone at the determined dose to test ovulation inhibition
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Drospirenone-only pill
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor