Clinical Trial: 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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional



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

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.)