35 Participants Needed

Drospirenone-only pill for Emergency Contraception

PK
ED
Overseen ByEva Dindinger, MPH
Age: 18 - 65
Sex: Female
Trial Phase: Phase 2
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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

You are in good overall health.
If patient is postpartum or post-second trimester abortion, she must have 3 menses (2 cycles) prior to enrollment
Consistent use of a barrier method or other non-hormonal birth control method throughout the study, or otherwise not at risk for pregnancy
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Exclusion Criteria

You have unexplained or abnormal bleeding from your uterus or genitals that has not been diagnosed.
You have a kidney condition or take certain medications that can affect your kidney function or electrolyte balance.
Currently taking any known CYP3A4 inducers/inhibitors
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Finding

Participants receive a single dose of drospirenone ranging from 16mg to 32mg to evaluate ovulation inhibition

1 week
Daily visits for 7 days

Primary Ovulation Inhibition Testing

Participants receive a single dose of drospirenone at the determined dose to test ovulation inhibition

1 week
Daily visits for 7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

Treatment Details

Interventions

  • Drospirenone-only pill
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

References

Drospirenone: a novel progestin. [2019]
YAZ and the novel progestin drospirenone. [2013]
Safety, influence on the endometrium, sonographic changes and bleeding profile after 13 cycles with the new drospirenone only pill (DOP) for contraception. [2021]
A randomised study comparing the effect on ovarian activity of a progestogen-only pill (POP) containing desogestrel and a new POP containing drospirenone in a 24/4 regimen. [2015]
Oestrogen-free oral contraception with a 4 mg drospirenone-only pill: new data and a review of the literature. [2022]
The association between drospirenone and hyperkalemia: a comparative-safety study. [2023]
Drospirenone/ethinyl estradiol. [2017]
Combined oral contraceptive with estetrol plus drospirenone: from pharmacokinetics to clinical applications. [2023]