This is a Phase 2, dose-finding, cross-over study for the purposes of evaluating the effect of a NES/E2 transdermal gel delivery on ovulation suppression in normal ovulating women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
18
Lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P\<10nmol/L) in 90-95% of the cycles. The high dose will deliver 4.5mg of NES; the medium dose will deliver 3mg of NES, and a low dose of 1.5mg of NES. Based on a 10% absorption rate, 450 µg/d, 300 µg/d and 150 µg/d will be absorbed respectively. The doses of Estradiol will also be tailored to the 3 formulations.
Women's and Children's Hospital; LA County/USC Medical Center
Los Angeles, California, United States
Instituto Chileno de Medicina Reproductiva
Santiago, Chile
Profamilia
Santo Domingo, Dominican Republic
Determine with ultrasound scan (USS) measures and serum progesterone (P) assessment the lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P<10nmol/L) in 90-95% of the cycles
Time frame: Subjects will remain in the study for approximately 8 months
Determine with USS and E2 serum levels the dose that can suppress follicle growth and replace estradiol at the physiological early follicular phase level
Time frame: Subjects will remain in the study for approximately 8 months
Evaluate the correlation of NES and E2 serum levels with the percentage of ovulation suppression
Time frame: Subjects will remain in the study for approximately 8 months
Evaluate the safety and tolerability of the formulations
Time frame: Subjects will remain in the study for approximately 8 months
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