This study will be a Phase 3, randomized, three-cycle, double-blind, placebo-controlled, parallel group, multiple-dose design. The study design has four phases: Screening Period; Open-Label Estrogen-Priming Period (Run-In Period); Blinded Treatment Period; and Follow-Up. The Open Label Priming Period and Blinded Treatment Period cover a total of three 28-day cycles. Clinical evaluations will be performed at the following time points: Screening Period: • Screening Period (approximately 42 Days) Open-Label Estrogen Priming Period (Run In Period): * Visit 1 Baseline (Cycle 1, Day 1) * Telephone Interview (Cycle 1, Day 28 \[- 3 d to ±1d\]) Blinded Treatment Period: * Visit 2 Randomization (Cycle 2, Day 12 \[±2d\]) * Visit 3 Interim (Cycle 3, Day 12 \[±2d\]) * Visit 4 End of treatment (Cycle 3, Day 24 \[±1d\]) Follow-Up Period: * Visit 5 Follow-Up (Approximately 10 days after the last treatment) * Telephone Interview (Approximately 2-4 weeks after completion of progestin course) (Only applies to subjects receiving an approved progestin therapy for proliferative endometrium, as determined by biopsy.)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
6
Precision Trials/New Horizons Women's Care
Chandler, Arizona, United States
Precision Clinical Trials/Arizona Wellness Center for Women
Phoenix, Arizona, United States
Visions Clinical Research
Tucson, Arizona, United States
California Family Health Council
Berkeley, California, United States
California Family Health Council
Los Angeles, California, United States
Clinical Research Consulting
Milford, Connecticut, United States
Nature Coast Clinical Research
Crystal River, Florida, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States
Cypress Medical Research Center
Wichita, Kansas, United States
Women's Clinic of Lincoln, P.C.
Lincoln, Nebraska, United States
...and 12 more locations
• The proportion of subjects at Cycle 3 Day 24 ± 1 day on active treatment compared to placebo with complete secretory activity on endometrial biopsy.
Time frame: 3 Cycles
• The proportion of subjects at Cycle 3 Day 24 ± 1 day on active treatment compared to placebo with total secretory activity (defined as the aggregate of partial and complete secretory activity) on endometrial biopsy.
Time frame: 3 cycles
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