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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
35
Single dose based on adaptive dose-finding design
University of Colorado Denver
Aurora, Colorado, United States
Serum progesterone concentration
Serum progesterone concentration measured after drug administration
Time frame: Measured daily for the seven days immediately following administration of the drospirenone-only pill dose during the Intervention cycle (each cycle is 21-35 days)
Dominant ovarian follicle ultrasound measurement
Measurement of the dominant ovarian follicle in three planes (width, length, height) using transvaginal ultrasound
Time frame: Measured daily for the seven days immediately following administration of the drospirenone-only pill dose during the Intervention cycle (cycle length 21-35 days)
Serum potassium concentration
Measured as a safety outcome
Time frame: Measured on the first and second days immediately following administration of the drospirenone-only pill dose during the Intervention cycle (cycle length 21-35 days)
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