Drospirenone-only pill for Emergency Contraception

Overseen By Eva Dindinger, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Colorado, Denver

Must not be taking: CYP3A4 inducers/inhibitors, Diuretics

Disqualifiers: Liver disease, Kidney disease, Hyperkalemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new emergency contraceptive pill made from drospirenone, a unique hormone, to determine if it can prevent ovulation before it starts. The goal is to provide a reliable emergency contraception option for individuals across different body weights, particularly since current options may be less effective for those with a higher BMI (body mass index). The study will include various groups to determine the right dose and test its effectiveness. Individuals with regular menstrual cycles and overall good health who use non-hormonal birth control methods might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in contraceptive options.

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 there any evidence suggesting that the drospirenone-only pill is likely to be safe for humans?

Research shows that drospirenone is generally safe for use. Studies have found it effective as a contraceptive and usually well-tolerated. Drospirenone-only pills are commonly used for birth control and are known for their safety. Researchers continue to study its effectiveness and safety for emergency contraception.

Using drospirenone carries a risk of blood clots, especially when combined with other hormones, as in some birth control pills. However, drospirenone-only pills, which lack estrogen, might present a different level of risk. It's important to consider personal health conditions and consult a healthcare provider before use.

In summary, drospirenone is generally considered safe, but further research is ongoing to confirm its safety as an emergency contraceptive. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most emergency contraceptives available today, like Plan B and ella, primarily use levonorgestrel or ulipristal acetate to prevent pregnancy. The drospirenone-only pill is unique because it offers a new active ingredient for emergency contraception. Drospirenone, unlike other hormones used in emergency contraceptives, might offer a different safety profile and potentially fewer side effects. Researchers are excited because this could provide a new option for those who may not respond well to existing treatments or are looking for alternatives with different hormonal impacts.

What evidence suggests that the drospirenone-only pill might be an effective treatment for emergency contraception?

Research has shown that drospirenone effectively stops ovulation, a key factor in emergency contraception. In earlier studies, pills containing only drospirenone resulted in a very low ovulation rate of just 0.9%, even when taken late, demonstrating its strong ability to prevent pregnancy. Another study found that drospirenone worked well for individuals of different body weights, including those who are overweight or obese. This suggests drospirenone could be a reliable choice for people of all body sizes, unlike some other emergency contraceptive pills. These findings support drospirenone as a promising option for emergency contraception.

In this trial, participants will receive a drospirenone-only pill in varying doses to determine the most effective dose for inhibiting ovulation. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Drospirenone-only pill

How Is the Trial Designed?

Group I: Primary ovulation inhibition testing Experimental Treatment 1 Intervention

Drospirenone-only pill single-dose at dose determined by dose finding arm

Group II: Dose finding Experimental Treatment 1 Intervention

Drospirenone-only pill single-dose ranging from 16mg to 32mg

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05675644

Drospirenone-only Pill as Emergency Contraception

Drospirenone is a unique progestin that effectively inhibits ovulation when taken daily as progestin-only oral contraception and has ...

2.

nature.com

nature.com/articles/s41598-024-64753-7

A randomized single-blind non-inferiority trial of delayed ...

DRSP-based POPs showed a low overall ovulation rate (0.9%) despite multiple intentional 24-h delays in pill intake, representing the same safety ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26232513/

Drospirenone-only Oral Contraceptive: Results From a ...

The primary efficacy endpoint was the overall Pearl Index (PI). Bleeding patterns, changes in vital signs and changes in laboratory values were also analyzed.

4.

contraceptionjournal.org

contraceptionjournal.org/article/S0010-7824(23)00230-5/fulltext

The efficacy, safety, and tolerability of an estrogen-free oral ...

Drospirenone 4 mg demonstrated similar contraceptive efficacy for both nonobese and obese users despite a difference in exposure based on bodyweight.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0010782422002153

Pooled efficacy results of estetrol/drospirenone combined ...

Pooled results from two phase 3 trials demonstrate high contraceptive efficacy of the novel estetrol-drospirenone oral contraceptive.

6.

mayoclinic.org

mayoclinic.org/drugs-supplements/drospirenone-and-ethinyl-estradiol-oral-route/description/drg-20061917

Drospirenone and ethinyl estradiol (oral route)

Using this medicine may increase your risk of having blood clotting problems, especially in the first 6 months of use. This risk may be higher ...

7.

cdc.gov

cdc.gov/contraception/hcp/usspr/progestin-only-pills.html

Progestin-Only Pills | Contraception

Progestin-only pills (POPs) contain only a progestin and no estrogen. Three formulations are currently available in the United States.

8.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2022/216285s000lbl.pdf

drospirenone - accessdata.fda.gov

The safety of Drospirenone Chewable Tablets has been established from studies of drospirenone tablets [see Clinical Studies (14)]. The data described below ...