Spots Global Cancer Trial Database for A Phase 3, Randomized, Three-Cycle, Double-Blind, Placebo-Controlled Study to Evaluate Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding for Secondary Amenorrhea
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Trial Identification
Brief Title: A Phase 3, Randomized, Three-Cycle, Double-Blind, Placebo-Controlled Study to Evaluate Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding for Secondary Amenorrhea
Official Title: A Phase 3, Randomized, Three-Cycle, Double-Blind, Placebo-Controlled Study to Evaluate Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding After Administration of TX-12-002-HR in Estrogen-Primed Women With Secondary Amenorrhea
Study ID: NCT02019589
Conditions
Study Description
Brief Summary: 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.)
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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
Lawrence OB-Gyn Clinical Research, Lawrenceville, New Jersey, United States
Suffolk OBGYN, Port Jefferson, New York, United States
Wake Research Associates, Raleigh, North Carolina, United States
Lyndhurst Clinical Research, Winston-Salem, North Carolina, United States
University of Cincinnati Physicians Company, Cincinnati, Ohio, United States
HWC Women's Research Center, Englewood, Ohio, United States
Vista Clinical Research, Columbia, South Carolina, United States
Chattanooga Medical Research, Chattanooga, Tennessee, United States
Methodist Charlton Medical Center, DeSoto, Texas, United States
The Woman's Hospital of Texas Clinical Research Center, Houston, Texas, United States
PRO/Salt Lake Women's Center, Sandy, Utah, United States
Tidewater Clinical Research, Virginia Beach, Virginia, United States
Contact Details
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