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Drospirenone-only Pill as Emergency Contraception

NCT05675644 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-01-09

No results posted yet for this study

Summary

Emergency contraception (EC) provides an additional measure to help prevent pregnancy after unprotected intercourse or contraceptive failure. The two currently available oral emergency contraceptive methods, levonorgestrel (LNG) and ulipristal acetate (UPA), have differing availability and effectiveness. Overweight and obesity are strong risk factors for failure of EC containing LNG and UPA for body mass index (BMI) ≥ 26kg/m2 and ≥35kg/m2, respectively, resulting in limited EC options for much of the population. Drospirenone is a unique progestin that effectively inhibits ovulation when taken daily as progestin-only oral contraception and has pharmacokinetic properties that make it a good candidate for a novel effective emergency contraceptive method across BMI categories.

The investigators propose a dose-finding, adaptive-design pilot study evaluating if a single dose of drospirenone can inhibit ovulation prior to the luteinizing hormone (LH) surge. The dose-finding study design will be conducted in a well-established 3+3 model with 2 planned study arms stratified by BMI. The investigators hypothesize that a single dose of drospirenone will effectively inhibit ovulation when administered prior to the LH surge. This pilot data will directly support the dose selection for future research further evaluating the efficacy of drospirenone-only EC aimed at ultimately increasing oral EC options, particularly for patients with overweight or obesity.

Conditions

  • Contraception

Interventions

DRUG

Drospirenone-only pill

Single dose based on adaptive dose-finding design

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05675644 on ClinicalTrials.gov