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Secondary Amenorrhea clinical trials

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NCT ID: NCT02019589 Terminated - Clinical trials for Secondary Amenorrhea

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

SPRY
Start date: January 20, 2014
Phase: Phase 3
Study type: Interventional

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.)